Trial Outcomes & Findings for Safety and Efficacy Study in in Vitro Fertilisation (IVF) Patients (NCT NCT01312766)
NCT ID: NCT01312766
Last Updated: 2016-07-22
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
270 participants
Primary outcome timeframe
up to 24 days after treatment start
Results posted on
2016-07-22
Participant Flow
Participant milestones
| Measure |
hMG-IBSA
New hMG preparation.
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
|
Menopur
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
|
|---|---|---|
|
Overall Study
STARTED
|
135
|
135
|
|
Overall Study
COMPLETED
|
129
|
130
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy Study in in Vitro Fertilisation (IVF) Patients
Baseline characteristics by cohort
| Measure |
hMG-IBSA
n=135 Participants
New hMG preparation.
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
|
Menopur
n=135 Participants
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
|
Total
n=270 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.3 years
STANDARD_DEVIATION 4.0 • n=5 Participants
|
33.0 years
STANDARD_DEVIATION 4.1 • n=7 Participants
|
33.1 years
STANDARD_DEVIATION 4.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
135 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
270 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
126 participants
n=5 Participants
|
126 participants
n=7 Participants
|
252 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 participants
n=5 Participants
|
6 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 24 days after treatment startOutcome measures
| Measure |
hMG-IBSA
n=135 Participants
New hMG preparation.
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
|
Menopur
n=135 Participants
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
|
|---|---|---|
|
Total Number of Oocytes Retrieved
|
11.6 number of oocytes
Standard Deviation 6.6
|
9.7 number of oocytes
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: up to 22 days after treatment startOutcome measures
| Measure |
hMG-IBSA
n=135 Participants
New hMG preparation.
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
|
Menopur
n=135 Participants
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
|
|---|---|---|
|
Mean hMG Dose (Total);
|
2171.4 Internationa Units (IU)
Standard Deviation 980
|
2303.6 Internationa Units (IU)
Standard Deviation 906
|
SECONDARY outcome
Timeframe: up to 28 days after treatment startPopulation: The population analysed corresponds to the patients who had at least one embryo to be analysed (i.e 120 participants in the hMG-IBSA group and 123 in the Menopur group). Of this, 119 in the hMG-IBSA group and 121 in the Menopur group underwent embryo transfer.
Assessed by counting the total number of embryos obtained, the number of embryos transferred, frozen and discarded.
Outcome measures
| Measure |
hMG-IBSA
n=120 Participants
New hMG preparation.
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
|
Menopur
n=123 Participants
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
|
|---|---|---|
|
Embryo Quality (Percentage of Patients With at Least One Top Quality Embryo)
|
63.3 percentage of participants
1.74
|
63.3 percentage of participants
1.65
|
SECONDARY outcome
Timeframe: up to 5 weeks after treatment startOutcome measures
| Measure |
hMG-IBSA
n=135 Participants
New hMG preparation.
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
|
Menopur
n=135 Participants
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
|
|---|---|---|
|
Positive b-hCG Test
|
43.7 percentage of participants
|
45.2 percentage of participants
|
SECONDARY outcome
Timeframe: up to 23 days after treatment startOutcome measures
| Measure |
hMG-IBSA
n=135 Participants
New hMG preparation.
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
|
Menopur
n=135 Participants
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
|
|---|---|---|
|
Controlled Ovarian Stimulation Duration (Days)
|
10.2 days
Standard Deviation 1.3
|
10.6 days
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: up to 23 days after treatment startOutcome measures
| Measure |
hMG-IBSA
n=135 Participants
New hMG preparation.
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
|
Menopur
n=135 Participants
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
|
|---|---|---|
|
17-β Estradiol (E2) Serum Concentration on the Monitoring Day Before hCG Injection;
|
2613.8 pg/ml
Standard Deviation 1531.6
|
2364.0 pg/ml
Standard Deviation 1441.6
|
SECONDARY outcome
Timeframe: 10-11 weeks after embryo transferdefined as the mean of the total number of implanted embryos (presence of gestational sac assessed by ultrasound) divided by the total number of transferred embryos x 100;
Outcome measures
| Measure |
hMG-IBSA
n=135 Participants
New hMG preparation.
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
|
Menopur
n=135 Participants
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
|
|---|---|---|
|
Implantation Rate
|
29.1 percentage of embryos transferred
Standard Deviation 41.0
|
28.2 percentage of embryos transferred
Standard Deviation 36.9
|
SECONDARY outcome
Timeframe: 10 - 11 weeks after embryo transferdefined as a pregnancy showing ultrasound embryonic heart activity at 10 - 11 weeks after embryo transfer;
Outcome measures
| Measure |
hMG-IBSA
n=135 Participants
New hMG preparation.
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
|
Menopur
n=135 Participants
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
|
|---|---|---|
|
Clinical Pregnancy Rate,
|
33.3 percentage of participants
|
37.1 percentage of participants
|
SECONDARY outcome
Timeframe: at the end of the stimulation.Outcome measures
| Measure |
hMG-IBSA
n=135 Participants
New hMG preparation.
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
|
Menopur
n=135 Participants
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
|
|---|---|---|
|
Number of Mature (Grade III Metaphase II) Oocytes Retrieved.
|
10.3 oocytes
Standard Deviation 6.0
|
8.2 oocytes
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: at the end of the stimulation.Percentage of retrieved oocytes considered to be mature.
Outcome measures
| Measure |
hMG-IBSA
n=135 Participants
New hMG preparation.
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
|
Menopur
n=135 Participants
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
|
|---|---|---|
|
Ratio Mature/Total Number of Oocytes Retrieved.
|
85 percentage of total oocytes retrieved
|
81 percentage of total oocytes retrieved
|
SECONDARY outcome
Timeframe: on the day of oocyte retrievalnumber of oocytes that were inseminated via IVF or injected via ICSI technique.
Outcome measures
| Measure |
hMG-IBSA
n=135 Participants
New hMG preparation.
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
|
Menopur
n=135 Participants
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
|
|---|---|---|
|
Total Number of Inseminated Oocytes (IVF and ICSI)
|
10.8 oocytes
Standard Deviation 5.9
|
8.4 oocytes
Standard Deviation 5.0
|
SECONDARY outcome
Timeframe: two days after inseminationOutcome measures
| Measure |
hMG-IBSA
n=135 Participants
New hMG preparation.
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
|
Menopur
n=135 Participants
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
|
|---|---|---|
|
Number of Cleaved Embryos
|
5.8 embryos
Standard Deviation 3.8
|
4.8 embryos
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: 9 months after treatmentOutcome measures
| Measure |
hMG-IBSA
n=135 Participants
New hMG preparation.
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
|
Menopur
n=135 Participants
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
|
|---|---|---|
|
Live Birth Rate
|
32.6 percentage of participants
|
36.3 percentage of participants
|
Adverse Events
hMG-IBSA
Serious events: 5 serious events
Other events: 46 other events
Deaths: 0 deaths
Menopur
Serious events: 8 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
hMG-IBSA
n=135 participants at risk
New hMG preparation.
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
|
Menopur
n=135 participants at risk
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
|
|---|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
0.74%
1/135 • Number of events 1
|
0.00%
0/135
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.74%
1/135 • Number of events 1
|
0.00%
0/135
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.74%
1/135 • Number of events 1
|
0.00%
0/135
|
|
Gastrointestinal disorders
Constipation
|
0.74%
1/135 • Number of events 1
|
0.00%
0/135
|
|
Gastrointestinal disorders
peritoneal heamorrage
|
0.74%
1/135 • Number of events 1
|
0.00%
0/135
|
|
Musculoskeletal and connective tissue disorders
back pain
|
0.00%
0/135
|
0.74%
1/135 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.74%
1/135 • Number of events 1
|
0.00%
0/135
|
|
Nervous system disorders
Headacje
|
0.74%
1/135 • Number of events 1
|
0.00%
0/135
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Incomplete
|
0.00%
0/135
|
0.74%
1/135 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Missed
|
1.5%
2/135 • Number of events 2
|
2.2%
3/135 • Number of events 3
|
|
Pregnancy, puerperium and perinatal conditions
Abortion threatened
|
0.74%
1/135 • Number of events 1
|
0.00%
0/135
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/135
|
0.74%
1/135 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
Hyperemesis gravidarum
|
0.00%
0/135
|
0.74%
1/135 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
Imminent abortion
|
0.00%
0/135
|
0.74%
1/135 • Number of events 1
|
|
Reproductive system and breast disorders
OHSS
|
0.74%
1/135 • Number of events 1
|
0.74%
1/135 • Number of events 1
|
|
Reproductive system and breast disorders
Ovarina torsion
|
0.74%
1/135 • Number of events 1
|
0.00%
0/135
|
|
Reproductive system and breast disorders
Vaginal haemorrage
|
0.00%
0/135
|
0.74%
1/135 • Number of events 1
|
Other adverse events
| Measure |
hMG-IBSA
n=135 participants at risk
New hMG preparation.
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
|
Menopur
n=135 participants at risk
Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
13.3%
18/135 • Number of events 23
|
10.4%
14/135 • Number of events 18
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.2%
7/135 • Number of events 7
|
4.4%
6/135 • Number of events 9
|
|
General disorders
fatigue
|
6.7%
9/135 • Number of events 10
|
5.9%
8/135 • Number of events 9
|
|
Nervous system disorders
Headache
|
15.6%
21/135 • Number of events 33
|
14.8%
20/135 • Number of events 32
|
|
Vascular disorders
Hot flushes
|
8.1%
11/135 • Number of events 13
|
1.5%
2/135 • Number of events 2
|
Additional Information
Dr. Barbara Cometti, Senior Clinical Research Manager, IBSA
IBSA Institut Biochimique SA
Phone: +41 58 360 10 00
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place