Trial Outcomes & Findings for A Trial to Compare the Efficacy and Safety of Ovarian Stimulation With GONAL-f® and Luveris® Starting on Day 1 Versus Day 6 in Women Undergoing Assisted Reproductive Technique (NCT NCT01497197)
NCT ID: NCT01497197
Last Updated: 2015-11-09
Results Overview
Ovarian stimulation was performed using in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). The total number of oocytes collected per subject following stimulation was reported.
TERMINATED
PHASE3
174 participants
34-38 hours post r-hCG administration
2015-11-09
Participant Flow
Participant milestones
| Measure |
Gonal-f®+Luveris
GONAL f® (Liquid Pen; 300 international units \[IU\] of per day) stimulation Day 1-5 then followed by Luveris® (vial/powder, 150 IU per day) from stimulation Day 1 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the centre's standard practice.
|
Gonal-f® Followed by Luveris
GONAL-f® (Liquid Pen; 300 IU per day) stimulation Day 1-5 then added Luveris® (vial/powder, 150 IU per day) from stimulation day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the centre's standard practice.
|
|---|---|---|
|
Overall Study
STARTED
|
89
|
85
|
|
Overall Study
COMPLETED
|
72
|
70
|
|
Overall Study
NOT COMPLETED
|
17
|
15
|
Reasons for withdrawal
| Measure |
Gonal-f®+Luveris
GONAL f® (Liquid Pen; 300 international units \[IU\] of per day) stimulation Day 1-5 then followed by Luveris® (vial/powder, 150 IU per day) from stimulation Day 1 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the centre's standard practice.
|
Gonal-f® Followed by Luveris
GONAL-f® (Liquid Pen; 300 IU per day) stimulation Day 1-5 then added Luveris® (vial/powder, 150 IU per day) from stimulation day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the centre's standard practice.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Excessive/lack of response to treatment
|
1
|
0
|
|
Overall Study
Risk of OHSS
|
1
|
0
|
|
Overall Study
No oocytes retrieved
|
3
|
2
|
|
Overall Study
No fertilisation
|
6
|
5
|
|
Overall Study
Intention to freeze all embryos
|
0
|
1
|
|
Overall Study
All embryos discarded
|
0
|
3
|
|
Overall Study
Other
|
3
|
1
|
Baseline Characteristics
A Trial to Compare the Efficacy and Safety of Ovarian Stimulation With GONAL-f® and Luveris® Starting on Day 1 Versus Day 6 in Women Undergoing Assisted Reproductive Technique
Baseline characteristics by cohort
| Measure |
Gonal-f®+Luveris
n=89 Participants
GONAL f® 300 international units \[IU\] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
|
Gonal-f® Followed by Luveris
n=85 Participants
GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
|
Total
n=174 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.8 years
STANDARD_DEVIATION 1.6 • n=5 Participants
|
38 years
STANDARD_DEVIATION 1.7 • n=7 Participants
|
37.9 years
STANDARD_DEVIATION 1.65 • n=5 Participants
|
|
Sex: Female, Male
Female
|
89 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 34-38 hours post r-hCG administrationPopulation: Modified intention-to-treat (MITT) included all the subjects randomized into the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed the primary efficacy assessment (total number of oocytes retrieved per subject following recombinant human follicle stimulating hormone (r-hFSH) stimulation and r-hCG injection).
Ovarian stimulation was performed using in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). The total number of oocytes collected per subject following stimulation was reported.
Outcome measures
| Measure |
Gonal-f®+Luveris
n=86 Participants
GONAL f® 300 international units \[IU\] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
|
Gonal-f® Followed by Luveris
n=82 Participants
GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
|
|---|---|---|
|
Total Number of Oocytes Retrieved Per Subject Following Ovarian Stimulation
|
8.6 oocytes
Standard Deviation 6.54
|
8.7 oocytes
Standard Deviation 5.77
|
SECONDARY outcome
Timeframe: ScreeningPopulation: Data was not analysed as per planned analysis due to frequent protocol violations/deviations, there was no subject eligible to be analyzed per protocol.
Mean daily dose of FSH was to be determined by dividing the total daily dose by the number of stimulation days.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 days post stimulation (Number of stimulation days+6 days)Population: MITT included all the subjects randomized into the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed the primary efficacy assessment (total number of oocytes retrieved per subject following r-hFSH stimulation and r-hCG injection).
The total number of stimulation treatment days for each subject was determined based on the treatment administration information collected in the case report form.
Outcome measures
| Measure |
Gonal-f®+Luveris
n=86 Participants
GONAL f® 300 international units \[IU\] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
|
Gonal-f® Followed by Luveris
n=82 Participants
GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
|
|---|---|---|
|
Total Number of Stimulation Treatment Days
|
11.1 days
Standard Deviation 2.42
|
11.3 days
Standard Deviation 2.24
|
SECONDARY outcome
Timeframe: 35-42 days post r-hCG administrationPopulation: MITT included all subjects randomized in the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed primary efficacy assessment(total number of oocytes retrieved/subject following r-hFSH stimulation and r-hCG injection). 'N' signifies all subjects who showed positive pregnancy test and evaluable for this outcome measure.
The implantation rate was determined as number of fetal sacs divided by the number of embryos transferred post r-hCG administration.
Outcome measures
| Measure |
Gonal-f®+Luveris
n=19 Participants
GONAL f® 300 international units \[IU\] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
|
Gonal-f® Followed by Luveris
n=21 Participants
GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
|
|---|---|---|
|
Implantation Rate
|
0.5 fetal sacs/embryo transferred
Standard Deviation 0.51
|
0.4 fetal sacs/embryo transferred
Standard Deviation 0.51
|
SECONDARY outcome
Timeframe: 35-42 days post r-hCG administrationPopulation: MITT included all subjects randomized in the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed primary efficacy assessment(total number of oocytes retrieved/subject following r-hFSH stimulation and r-hCG injection). 'N' signifies all participants who showed positive pregnancy test and evaluable for this outcome measure.
Number of fetal sacs with activity was evaluated by ultrasound scan (US) on Days 35-42 post r-hCG to confirm clinical pregnancy.
Outcome measures
| Measure |
Gonal-f®+Luveris
n=19 Participants
GONAL f® 300 international units \[IU\] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
|
Gonal-f® Followed by Luveris
n=21 Participants
GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
|
|---|---|---|
|
Number of Fetal Sacs With Activity
|
0.8 Fetal sacs
Standard Deviation 0.42
|
1.1 Fetal sacs
Standard Deviation 0.54
|
SECONDARY outcome
Timeframe: 35-42 days post r-hCG administrationPopulation: MITT included all subjects randomized in the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed primary efficacy assessment(total number of oocytes retrieved/subject following r-hFSH stimulation and r-hCG injection). 'N' signifies all participants who showed positive pregnancy test and evaluable for this outcome measure.
Number of fetal sacs with detectable heart beats was evaluated by US on Days 35-42 post r-hCG to confirm clinical pregnancy
Outcome measures
| Measure |
Gonal-f®+Luveris
n=19 Participants
GONAL f® 300 international units \[IU\] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
|
Gonal-f® Followed by Luveris
n=21 Participants
GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
|
|---|---|---|
|
Number of Fetal Sacs With Detectable Heart Beats
|
0.6 Fetal sacs
Standard Deviation 0.50
|
1.0 Fetal sacs
Standard Deviation 0.45
|
SECONDARY outcome
Timeframe: 35-42 days post r-hCG administrationPopulation: MITT included all the subjects randomized into the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed the primary efficacy assessment (total number of oocytes retrieved per subject following r-hFSH stimulation and r-hCG injection).
The subject was considered to have a positive pregnancy result if beta-hCG \>10 international units per liter (IU/L) and the subject had not menstruated between post-r-hCG Days 15-20. Clinical pregnancy was defined as the existence of at least an US confirmed gestational sac in the uterus with fetal heart activity post-r-hCG Days 35-42.
Outcome measures
| Measure |
Gonal-f®+Luveris
n=86 Participants
GONAL f® 300 international units \[IU\] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
|
Gonal-f® Followed by Luveris
n=82 Participants
GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
|
|---|---|---|
|
Total Pregnancy Rate and Clinical Pregnancy Rate
Total pregnancy
|
20 percentage of subjects
|
27 percentage of subjects
|
|
Total Pregnancy Rate and Clinical Pregnancy Rate
Clinical pregnancy
|
17 percentage of subjects
|
23 percentage of subjects
|
SECONDARY outcome
Timeframe: Up to 85 daysPopulation: MITT included all the subjects randomized into the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed the primary efficacy assessment (total number of oocytes retrieved per subject following r-hFSH stimulation and r-hCG injection).
If the subject was not administered with r-hCG and withdrew prematurely from the trial, it was considered as cycle cancellation.
Outcome measures
| Measure |
Gonal-f®+Luveris
n=86 Participants
GONAL f® 300 international units \[IU\] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
|
Gonal-f® Followed by Luveris
n=82 Participants
GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
|
|---|---|---|
|
Cycle Cancellation Rate Prior to r-hCG
|
0 percentage of subjects
|
0 percentage of subjects
|
SECONDARY outcome
Timeframe: 35 to 42 days post r-hCG administrationPopulation: MITT included all the subjects randomized into the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed the primary efficacy assessment (total number of oocytes retrieved per subject following r-hFSH stimulation and r-hCG injection).
Biochemical pregnancy was defined as the pregnancy diagnosed only by the detection of hCG in serum or urine and that does not develop into a clinical pregnancy. Subjects with beta-hCG concentration greater than 10 IU/L were considered as biochemical pregnant.
Outcome measures
| Measure |
Gonal-f®+Luveris
n=86 Participants
GONAL f® 300 international units \[IU\] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
|
Gonal-f® Followed by Luveris
n=82 Participants
GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
|
|---|---|---|
|
Number of Subjects With Biochemical Pregnancies
|
2 subjects
|
1 subjects
|
SECONDARY outcome
Timeframe: 35 to 42 days post r-hCG administrationPopulation: MITT included all subjects randomized into trial who received at least 1 dose of Gonal-f® or Luveris®, and completed the primary efficacy assessment (total number of oocytes retrieved per subject following r-hFSH stimulation and r-hCG injection). 'N'=signifies all subjects who showed positive pregnancy test and evaluable for this outcome measure.
Multiple pregnancy was defined as the existence of more than one ultrasound confirmed gestational sac in the uterus with fetal heart activity at post-r-hCG Days 35-42.
Outcome measures
| Measure |
Gonal-f®+Luveris
n=19 Participants
GONAL f® 300 international units \[IU\] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
|
Gonal-f® Followed by Luveris
n=21 Participants
GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
|
|---|---|---|
|
Number of Subjects With Multiple Pregnancies
|
0 subjects
|
4 subjects
|
SECONDARY outcome
Timeframe: Baseline up to 15-20 days post r-hCG administrationPopulation: Safety population included all randomized subjects who received at least one dose of the trial treatment.
An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A serious AE is an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
Outcome measures
| Measure |
Gonal-f®+Luveris
n=89 Participants
GONAL f® 300 international units \[IU\] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
|
Gonal-f® Followed by Luveris
n=85 Participants
GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
|
|---|---|---|
|
Number of Subjects With Any Adverse Events (AEs), Serious AEs, AEs Leading to Death, and AEs Leading to Discontinuation
AEs
|
27 subjects
|
28 subjects
|
|
Number of Subjects With Any Adverse Events (AEs), Serious AEs, AEs Leading to Death, and AEs Leading to Discontinuation
Serious AEs
|
4 subjects
|
5 subjects
|
|
Number of Subjects With Any Adverse Events (AEs), Serious AEs, AEs Leading to Death, and AEs Leading to Discontinuation
AEs Leading to Death
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Any Adverse Events (AEs), Serious AEs, AEs Leading to Death, and AEs Leading to Discontinuation
AEs Leading to Discontinuation
|
1 subjects
|
3 subjects
|
Adverse Events
Gonal-f®+Luveris
Gonal-f® Followed by Luveris
Serious adverse events
| Measure |
Gonal-f®+Luveris
n=89 participants at risk
GONAL f® 300 international units \[IU\] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
|
Gonal-f® Followed by Luveris
n=85 participants at risk
GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
2.2%
2/89 • Baseline up to 15-20 days post r-hCG administration
|
4.7%
4/85 • Baseline up to 15-20 days post r-hCG administration
|
|
Reproductive system and breast disorders
Ovarian cyst
|
2.2%
2/89 • Baseline up to 15-20 days post r-hCG administration
|
1.2%
1/85 • Baseline up to 15-20 days post r-hCG administration
|
Other adverse events
| Measure |
Gonal-f®+Luveris
n=89 participants at risk
GONAL f® 300 international units \[IU\] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
|
Gonal-f® Followed by Luveris
n=85 participants at risk
GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Overdose
|
14.6%
13/89 • Baseline up to 15-20 days post r-hCG administration
|
16.5%
14/85 • Baseline up to 15-20 days post r-hCG administration
|
|
Investigations
Oestradiol increased
|
9.0%
8/89 • Baseline up to 15-20 days post r-hCG administration
|
9.4%
8/85 • Baseline up to 15-20 days post r-hCG administration
|
|
Investigations
Progesterone increased
|
0.00%
0/89 • Baseline up to 15-20 days post r-hCG administration
|
1.2%
1/85 • Baseline up to 15-20 days post r-hCG administration
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/89 • Baseline up to 15-20 days post r-hCG administration
|
1.2%
1/85 • Baseline up to 15-20 days post r-hCG administration
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
2.2%
2/89 • Baseline up to 15-20 days post r-hCG administration
|
5.9%
5/85 • Baseline up to 15-20 days post r-hCG administration
|
|
Reproductive system and breast disorders
Breast pain
|
1.1%
1/89 • Baseline up to 15-20 days post r-hCG administration
|
0.00%
0/85 • Baseline up to 15-20 days post r-hCG administration
|
Additional Information
Merck KGaA Communication Center
Merck Serono, a division of Merck KGaA
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60