Trial Outcomes & Findings for CONSORT Randomized Controlled Trial in Assisted Reproductive Technology (NCT NCT00829244)
NCT ID: NCT00829244
Last Updated: 2014-02-13
Results Overview
Mean number of oocytes retrieved on the day of ovum pick up (OPU) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
200 participants
Primary outcome timeframe
34-38 hours post-recombinant human choriogonadotropin (hCG) (OPU)
Results posted on
2014-02-13
Participant Flow
Participants were enrolled at 22 clinical trial centers in 9 European countries and 1 center in Chile. Recruitment period: 29 August 2008 to 21 January 2010.
A total of 244 participants gave informed consent and were screened for study entry. Forty-four (44) of these participants were not randomized due to: screening failure (38), failure to down regulate (3), or other reasons (3). A total of 200 participants were randomized to one of the two treatment arms.
Participant milestones
| Measure |
GONAL-f ® CONSORT Calculator
GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone \[r-FSH\] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
|
GONAL-f ® Standard Treatment
GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
|
|---|---|---|
|
Overall Study
STARTED
|
96
|
104
|
|
Overall Study
COMPLETED
|
82
|
83
|
|
Overall Study
NOT COMPLETED
|
14
|
21
|
Reasons for withdrawal
| Measure |
GONAL-f ® CONSORT Calculator
GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone \[r-FSH\] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
|
GONAL-f ® Standard Treatment
GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
3
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Lack of ovarian response to stimulation
|
9
|
5
|
|
Overall Study
Ovarian hyperstimulation syndrome (OHSS)
|
1
|
6
|
|
Overall Study
No fertilization
|
2
|
2
|
|
Overall Study
All embryos discarded
|
0
|
3
|
|
Overall Study
No embryo cleavage
|
0
|
2
|
Baseline Characteristics
CONSORT Randomized Controlled Trial in Assisted Reproductive Technology
Baseline characteristics by cohort
| Measure |
GONAL-f ® CONSORT Calculator
n=96 Participants
GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone \[r-FSH\] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
|
GONAL-f ® Standard Treatment
n=104 Participants
GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
96 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
30.0 years
STANDARD_DEVIATION 2.9 • n=5 Participants
|
30.6 years
STANDARD_DEVIATION 2.6 • n=7 Participants
|
30.3 years
STANDARD_DEVIATION 2.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
96 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Chile
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
26 participants
n=5 Participants
|
26 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Region of Enrollment
France
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
13 participants
n=5 Participants
|
16 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
11 participants
n=5 Participants
|
14 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Serum Anti-Mullerian Hormone (AMH)
|
2.705 nanogram/milliliter (ng/mL)
STANDARD_DEVIATION 1.870 • n=5 Participants
|
2.399 nanogram/milliliter (ng/mL)
STANDARD_DEVIATION 1.492 • n=7 Participants
|
2.551 nanogram/milliliter (ng/mL)
STANDARD_DEVIATION 1.692 • n=5 Participants
|
|
Serum Progesterone (P4)
|
2.934 nanomole/liter (nmol/L)
STANDARD_DEVIATION 2.328 • n=5 Participants
|
2.803 nanomole/liter (nmol/L)
STANDARD_DEVIATION 2.291 • n=7 Participants
|
2.868 nanomole/liter (nmol/L)
STANDARD_DEVIATION 2.303 • n=5 Participants
|
PRIMARY outcome
Timeframe: 34-38 hours post-recombinant human choriogonadotropin (hCG) (OPU)Population: The modified Intention-To-Treat (ITT) population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.
Mean number of oocytes retrieved on the day of ovum pick up (OPU) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.
Outcome measures
| Measure |
GONAL-f ® CONSORT Calculator
n=86 Participants
GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone \[r-FSH\] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
|
GONAL-f ® Standard Treatment
n=93 Participants
GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
|
|---|---|---|
|
Number of Oocytes Retrieved Per Participant
|
10.0 oocytes
Standard Deviation 5.6
|
11.8 oocytes
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: Start of treatment until end of stimulation cycle (approximately 28 days)Population: The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.
Outcome measures
| Measure |
GONAL-f ® CONSORT Calculator
n=86 Participants
GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone \[r-FSH\] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
|
GONAL-f ® Standard Treatment
n=93 Participants
GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
|
|---|---|---|
|
Total GONAL-f® Dose
|
1288.54 IU
Standard Deviation 300.95
|
1809.95 IU
Standard Deviation 546.90
|
SECONDARY outcome
Timeframe: Start of treatment until end of stimulation cycle (approximately 28 days)Population: The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.
Outcome measures
| Measure |
GONAL-f ® CONSORT Calculator
n=86 Participants
GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone \[r-FSH\] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
|
GONAL-f ® Standard Treatment
n=93 Participants
GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
|
|---|---|---|
|
Mean GONAL-f® Daily Dose
|
121.49 IU
Standard Deviation 22.56
|
167.43 IU
Standard Deviation 30.79
|
SECONDARY outcome
Timeframe: Start of treatment until end of stimulation cycle (approximately 28 days)Population: The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.
Outcome measures
| Measure |
GONAL-f ® CONSORT Calculator
n=86 Participants
GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone \[r-FSH\] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
|
GONAL-f ® Standard Treatment
n=93 Participants
GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
|
|---|---|---|
|
Total Number of GONAL-f® Stimulation Treatment Days
|
10.6 days
Standard Deviation 1.7
|
10.7 days
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: Start of treatment until Day 15-20 post-hCGPopulation: All the randomized participants were analyzed for this outcome measure (N=200).
Number of participants with cancelled cycles due to excessive or inadequate response was evaluated. An excessive response: greater than or equal to 25 oocytes which could put the participant at risk of OHSS; An inadequate response: defined as 3 or less follicles of greater than or equal to 12 millimeter (mm) developing following at least 7 days of GONAL-f® treatment.
Outcome measures
| Measure |
GONAL-f ® CONSORT Calculator
n=96 Participants
GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone \[r-FSH\] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
|
GONAL-f ® Standard Treatment
n=104 Participants
GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
|
|---|---|---|
|
Number of Participants With Cancelled Cycles Due to Excessive or Inadequate Response to Treatment
Inadequate response
|
9 Participants
|
5 Participants
|
|
Number of Participants With Cancelled Cycles Due to Excessive or Inadequate Response to Treatment
Excessive response (Risk of OHSS)
|
1 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Start of treatment until Day 15-20 Post-hCGPopulation: The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.
Biochemical pregnancy was defined as a pregnancy diagnosed only by the detection of hCG in serum and that does not develop into a clinical pregnancy.
Outcome measures
| Measure |
GONAL-f ® CONSORT Calculator
n=86 Participants
GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone \[r-FSH\] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
|
GONAL-f ® Standard Treatment
n=93 Participants
GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
|
|---|---|---|
|
Percentage of Participants With Biochemical Pregnancies
|
47.7 percentage of participants
|
44.1 percentage of participants
|
SECONDARY outcome
Timeframe: Day 35-42 Post-hCGPopulation: The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.
Number of participants with fetal sacs and fetal hearts (with activity) as seen on an ultrasound scan to confirm clinical pregnancy.
Outcome measures
| Measure |
GONAL-f ® CONSORT Calculator
n=86 Participants
GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone \[r-FSH\] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
|
GONAL-f ® Standard Treatment
n=93 Participants
GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
|
|---|---|---|
|
Number of Participants With Fetal Sacs and Fetal Hearts
Missing (fetal sacs and fetal hearts)
|
47 participants
|
57 participants
|
|
Number of Participants With Fetal Sacs and Fetal Hearts
0 (fetal sacs)
|
6 participants
|
1 participants
|
|
Number of Participants With Fetal Sacs and Fetal Hearts
1 (fetal sacs)
|
27 participants
|
25 participants
|
|
Number of Participants With Fetal Sacs and Fetal Hearts
2 (fetal sacs)
|
5 participants
|
10 participants
|
|
Number of Participants With Fetal Sacs and Fetal Hearts
3 (fetal sacs)
|
1 participants
|
0 participants
|
|
Number of Participants With Fetal Sacs and Fetal Hearts
0 (fetal hearts)
|
8 participants
|
3 participants
|
|
Number of Participants With Fetal Sacs and Fetal Hearts
1 (fetal hearts)
|
25 participants
|
24 participants
|
|
Number of Participants With Fetal Sacs and Fetal Hearts
2 (fetal hearts)
|
5 participants
|
9 participants
|
|
Number of Participants With Fetal Sacs and Fetal Hearts
3 (fetal hearts)
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 35-42 Post-hCGPopulation: The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.
Implantation rate was measured as the number of gestational sacs observed divided by the number of embryos transferred multiplied by 100.
Outcome measures
| Measure |
GONAL-f ® CONSORT Calculator
n=86 Participants
GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone \[r-FSH\] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
|
GONAL-f ® Standard Treatment
n=93 Participants
GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
|
|---|---|---|
|
Implantation Rate
|
31.1 percent sacs per embryo
Standard Deviation 41.3
|
31.2 percent sacs per embryo
Standard Deviation 40.8
|
SECONDARY outcome
Timeframe: Day 35-42 Post-hCGPopulation: The modified ITT population. Number of participants analyzed (N) signifies those participants who were evaluated for this outcome measure.
Multiple pregnancy was defined as 2 or more fetal hearts with activity.
Outcome measures
| Measure |
GONAL-f ® CONSORT Calculator
n=39 Participants
GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone \[r-FSH\] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
|
GONAL-f ® Standard Treatment
n=36 Participants
GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
|
|---|---|---|
|
Number of Participants With Multiple Pregnancies
|
6 participants
|
9 participants
|
SECONDARY outcome
Timeframe: End of stimulation cycle (approximately 28 days)Population: The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.
Outcome measures
| Measure |
GONAL-f ® CONSORT Calculator
n=86 Participants
GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone \[r-FSH\] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
|
GONAL-f ® Standard Treatment
n=93 Participants
GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
|
|---|---|---|
|
Serum Progesterone (P4) Levels
|
5.41 nmol/L
Standard Deviation 7.57
|
4.88 nmol/L
Standard Deviation 2.22
|
SECONDARY outcome
Timeframe: Day 35-42 Post-hCGPopulation: The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.
Clinical pregnancy is defined by the number of sacs and hearts with activity per ultrasound scan performed on Day 35-42 post-hCG.
Outcome measures
| Measure |
GONAL-f ® CONSORT Calculator
n=86 Participants
GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone \[r-FSH\] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
|
GONAL-f ® Standard Treatment
n=93 Participants
GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
|
|---|---|---|
|
Percentage of Participants With Clinical Pregnancy
|
36.0 percentage of participants
|
35.5 percentage of participants
|
SECONDARY outcome
Timeframe: Start of treatment until Day 15-20 Post-hCGPopulation: Safety population included all the participants who were randomized.
OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting.
Outcome measures
| Measure |
GONAL-f ® CONSORT Calculator
n=96 Participants
GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone \[r-FSH\] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
|
GONAL-f ® Standard Treatment
n=104 Participants
GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
|
|---|---|---|
|
Number of Participants With OHSS
|
6 participants
|
13 participants
|
SECONDARY outcome
Timeframe: up to 9 month (following the end of treatment)Population: The modified ITT population included all participants randomized into trial who received at least 1 dose of GONAL-f®, and who completed primary efficacy assessment (total number of oocytes retrieved per participant following GONAL-f® stimulation and hCG injection). Participants were analyzed based on treatment they received.
Pregnancy outcomes are live outcome (live infant) and non-live outcome (non-live infant) or unknown outcome (subject lost to follow-up).
Outcome measures
| Measure |
GONAL-f ® CONSORT Calculator
n=31 Participants
GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone \[r-FSH\] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
|
GONAL-f ® Standard Treatment
n=33 Participants
GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
|
|---|---|---|
|
Pregnancy Outcome - Number of Participants With Pregnancy and Their Outcome
Live outcomes
|
24 participants
|
25 participants
|
|
Pregnancy Outcome - Number of Participants With Pregnancy and Their Outcome
Non-live outcomes
|
2 participants
|
3 participants
|
|
Pregnancy Outcome - Number of Participants With Pregnancy and Their Outcome
Unknown outcomes
|
5 participants
|
5 participants
|
Adverse Events
GONAL-f ® CONSORT Calculator
Serious events: 4 serious events
Other events: 40 other events
Deaths: 0 deaths
GONAL-f ® Standard Treatment
Serious events: 3 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GONAL-f ® CONSORT Calculator
n=96 participants at risk
GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone \[r-FSH\] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
|
GONAL-f ® Standard Treatment
n=104 participants at risk
GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
|
|---|---|---|
|
Reproductive system and breast disorders
Ovarian hyperstimulation syndrome
|
2.1%
2/96 • Number of events 2 • Adverse Events (AEs) were collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the final treatment examination, on Day 15-20 of the post-treatment assessment period
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study; Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication.
|
1.9%
2/104 • Number of events 2 • Adverse Events (AEs) were collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the final treatment examination, on Day 15-20 of the post-treatment assessment period
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study; Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.0%
1/96 • Number of events 1 • Adverse Events (AEs) were collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the final treatment examination, on Day 15-20 of the post-treatment assessment period
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study; Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication.
|
0.00%
0/104 • Adverse Events (AEs) were collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the final treatment examination, on Day 15-20 of the post-treatment assessment period
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study; Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
1.0%
1/96 • Number of events 1 • Adverse Events (AEs) were collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the final treatment examination, on Day 15-20 of the post-treatment assessment period
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study; Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication.
|
0.00%
0/104 • Adverse Events (AEs) were collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the final treatment examination, on Day 15-20 of the post-treatment assessment period
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study; Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/96 • Adverse Events (AEs) were collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the final treatment examination, on Day 15-20 of the post-treatment assessment period
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study; Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication.
|
0.96%
1/104 • Number of events 1 • Adverse Events (AEs) were collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the final treatment examination, on Day 15-20 of the post-treatment assessment period
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study; Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication.
|
Other adverse events
| Measure |
GONAL-f ® CONSORT Calculator
n=96 participants at risk
GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone \[r-FSH\] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
|
GONAL-f ® Standard Treatment
n=104 participants at risk
GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
8.3%
8/96 • Number of events 9 • Adverse Events (AEs) were collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the final treatment examination, on Day 15-20 of the post-treatment assessment period
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study; Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication.
|
8.7%
9/104 • Number of events 11 • Adverse Events (AEs) were collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the final treatment examination, on Day 15-20 of the post-treatment assessment period
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study; Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication.
|
|
Gastrointestinal disorders
Abdominal distension
|
8.3%
8/96 • Number of events 8 • Adverse Events (AEs) were collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the final treatment examination, on Day 15-20 of the post-treatment assessment period
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study; Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication.
|
2.9%
3/104 • Number of events 5 • Adverse Events (AEs) were collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the final treatment examination, on Day 15-20 of the post-treatment assessment period
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study; Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication.
|
|
Nervous system disorders
Headache
|
18.8%
18/96 • Number of events 30 • Adverse Events (AEs) were collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the final treatment examination, on Day 15-20 of the post-treatment assessment period
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study; Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication.
|
24.0%
25/104 • Number of events 40 • Adverse Events (AEs) were collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the final treatment examination, on Day 15-20 of the post-treatment assessment period
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study; Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication.
|
|
Reproductive system and breast disorders
Adnexa uteri pain
|
9.4%
9/96 • Number of events 10 • Adverse Events (AEs) were collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the final treatment examination, on Day 15-20 of the post-treatment assessment period
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study; Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication.
|
7.7%
8/104 • Number of events 9 • Adverse Events (AEs) were collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the final treatment examination, on Day 15-20 of the post-treatment assessment period
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study; Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication.
|
|
Reproductive system and breast disorders
Ovarian hyperstimulation syndrome
|
5.2%
5/96 • Number of events 5 • Adverse Events (AEs) were collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the final treatment examination, on Day 15-20 of the post-treatment assessment period
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study; Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication.
|
10.6%
11/104 • Number of events 12 • Adverse Events (AEs) were collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the final treatment examination, on Day 15-20 of the post-treatment assessment period
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study; Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
9.4%
9/96 • Number of events 9 • Adverse Events (AEs) were collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the final treatment examination, on Day 15-20 of the post-treatment assessment period
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study; Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication.
|
4.8%
5/104 • Number of events 5 • Adverse Events (AEs) were collected on an ongoing basis from day of written informed consent. All new AEs must be recorded until the final treatment examination, on Day 15-20 of the post-treatment assessment period
Pre-Treatment:Medical conditions present at the initial study visit that did not worsen in severity or frequency during the study; Treatment-Emergent: If the onset date of the AE was on or after the first dose date of the study medication.
|
Additional Information
Merck KGaA Communication Center
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Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The PI shall submit any results communication to the sponsor for review and comment at least 30 business days prior to submission. The sponsor shall have the right to request the PI to delete or modify any of sponsor's proprietary information contained therein. If the PI does not agree to the deletion or appropriate modification of such information, it shall postpone submission for publication or presentation for 60 days from the date the PI notifies the sponsor.
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Restriction type: OTHER