Infertility
Conditions
Keywords
Reproductive Techniques, Assisted, Follicle Stimulating Hormone, Human, Fertilization In Vitro
Brief summary
The purpose of this follow-up study is to collect the outcome and safety of FTET cycles after the embryos are cryopreserved in P06029 (NCT01144416). P06029 was a study in which a single injection of corifollitropin alfa (SCH 900962) was compared with daily recombinant follicle stimulating hormone (recFSH) injections in women aged 35 to 42 years undergoing controlled ovarian stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).
Interventions
BIOLOGICALCorifollitropin alfa
Single injection of 150 μg corifollitropin alfa administered under protocol P06029
BIOLOGICALrecFSH (follitropin beta)
Daily recFSH 300 IU administered under protocol P06029.
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 42 Years
Healthy volunteers
No
Inclusion criteria
* Participant must have provided written informed consent for the trial. * Participant must have cryopreserved embryo(s) in trial P06029 (NCT01144416) of which at least one embryo is thawed for use in a subsequent FTET cycle.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With ≥1 Vital Pregnancy (Cumulative Vital Pregnancy Rate) | Assessed at least 35 days after ET in COS cycle in Base Study P06029 or an FTET cycle in Follow-Up Study P06031 (up to 2 years) | The cumulative vital pregnancy rate was defined as the number of participants with at least 1 vital pregnancy in a controlled ovarian stimulation (COS) cycle in Base Study P06029 or a frozen-thawed embryo transfer (FTET) in Follow Up Study P06031, divided by the total number of participants in each Full Analysis Set (FAS) treatment group. A vital pregnancy was defined as an intrauterine pregnancy with fetal heart tones assessed at least 35 days (≥5 weeks) after embryo transfer (ET). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With ≥1 Live Birth (Cumulative Live-Birth Rate) | From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to time of delivery (up to 2 years) | The cumulative live-birth rate was defined as the number of participants with at least 1 live birth after ET in a COS cycle in Base Study P06029 or an FTET in Follow-Up Study P06031, divided by the total number of participants in each FAS treatment group. |
Participant flow
Pre-assignment details
Period 1 consists of participants from Base Study P06029 (NCT01144416) randomized to treatment groups corifollitropin alfa or recombinant follicle stimulating hormone (recFSH). Period 2 consists of participants from base study enrolled in Follow-Up Study P06031. Period 3 consists of infants born to expectant mothers in Follow-Up Study P06031.
Participants by arm
| Arm | Count |
|---|---|
| Corifollitropin Alfa 150 μg Women/Expectant Mothers Participants in Base Study P06029 (NCT01144416) received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study. | 151 |
| recFSH 300 IU Women/Expectant Mothers Participants in the reference group in Base Study P06029 (NCT01144416) received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study. | 147 |
| Total | 298 |
Baseline characteristics
| Characteristic | Corifollitropin Alfa 150 μg Women/Expectant Mothers | recFSH 300 IU Women/Expectant Mothers | Total |
|---|---|---|---|
| Age, Continuous | 38.5 Years STANDARD_DEVIATION 2.1 | 38.3 Years STANDARD_DEVIATION 2.2 | 38.4 Years STANDARD_DEVIATION 2.2 |
| Sex: Female, Male Female | 151 Participants | 147 Participants | 298 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 64 / 151 | 45 / 147 | 26 / 52 | 19 / 50 | 18 / 61 | 21 / 56 |
| serious Total, serious adverse events | 4 / 151 | 3 / 147 | 34 / 52 | 29 / 50 | 15 / 61 | 17 / 56 |
Outcome results
Primary
Percentage of Participants With ≥1 Vital Pregnancy (Cumulative Vital Pregnancy Rate)
The cumulative vital pregnancy rate was defined as the number of participants with at least 1 vital pregnancy in a controlled ovarian stimulation (COS) cycle in Base Study P06029 or a frozen-thawed embryo transfer (FTET) in Follow Up Study P06031, divided by the total number of participants in each Full Analysis Set (FAS) treatment group. A vital pregnancy was defined as an intrauterine pregnancy with fetal heart tones assessed at least 35 days (≥5 weeks) after embryo transfer (ET).
Time frame: Assessed at least 35 days after ET in COS cycle in Base Study P06029 or an FTET cycle in Follow-Up Study P06031 (up to 2 years)
Population: Full Analysis Set (FAS) population consisted of all randomized participants who received corifollitropin alfa or recFSH in Base Study P06029.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Corifollitropin Alfa 150 μg Women/Expectant Mothers | Percentage of Participants With ≥1 Vital Pregnancy (Cumulative Vital Pregnancy Rate) | 31.1 Percentage of Participants |
| recFSH 300 IU Women/Expectant Mothers | Percentage of Participants With ≥1 Vital Pregnancy (Cumulative Vital Pregnancy Rate) | 33.0 Percentage of Participants |
95% CI: [-6.5, 3]Clopper-Pearson method
Secondary
Percentage of Participants With ≥1 Live Birth (Cumulative Live-Birth Rate)
The cumulative live-birth rate was defined as the number of participants with at least 1 live birth after ET in a COS cycle in Base Study P06029 or an FTET in Follow-Up Study P06031, divided by the total number of participants in each FAS treatment group.
Time frame: From approximately 10 weeks after ET in Base Study P06029 or FTET in Follow-Up Study P06031 up to time of delivery (up to 2 years)
Population: FAS population consisted of all randomized participants who received corifollitropin alfa or recFSH in Base Study P06029.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Corifollitropin Alfa 150 μg Women/Expectant Mothers | Percentage of Participants With ≥1 Live Birth (Cumulative Live-Birth Rate) | 28.2 Percentage of Participants |
| recFSH 300 IU Women/Expectant Mothers | Percentage of Participants With ≥1 Live Birth (Cumulative Live-Birth Rate) | 29.5 Percentage of Participants |
95% CI: [-5.7, 3.4]Clopper-Pearson method