Primary outcomeNumber· Up to one day following delivery (up to 1 year)
Number of Mothers in Current Follow Up Trial Experiencing Adverse Events (AEs)
| Group | Value (Participants) |
|---|---|
| Mothers Corifollitropin Alfa 150 µg | 222 |
| Mothers recFSH 200 IU | 214 |
Trial · Observational
CompletedPhase not statedResults postedRegistry dataPregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05787 (P05712)
NCTNCT00703014 (opens ClinicalTrials.gov in a new tab)Other idP05712Other id2004-004772-36Other id38821Other idMK-8962-005
Overview
- Status
- Completed
- Phase
- Phase not stated
- Enrollment
- 541 participants (actual)
- Sponsor
- Organon and Co · Industry
- Design
- Not stated
- Countries
- Not stated
- Start
- 13 Jul 2006
- Primary completion
- 18 Apr 2008
- Completion
- 15 Mar 2009
- First posted
- 20 Jun 2008 (estimated)
- Last update posted
- 19 Sept 2024
- Conditions
- Pregnancy · Neonates
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20062007200820092010
- Ph –
Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05787 (P05712)
NCT0070301413 Jul 2006 to 15 Mar 2009
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The objective of this trial was to evaluate whether Corifollitropin Alfa treatment for the induction of multifollicular growth in women undergoing controlled ovarian stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) was safe for pregnant participants and their offspring. The primary endpoint was the take-home baby rate calculated as the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800) with at least one live born infant relative to the number of participants in the Base Trial, and to the number of participants in the Base Trial with Embryo Transfer (ET).
Interventions
- Corifollitropin Alfa 150 μgDrug
- 200 IU RecFSH/Follitropin beta (Days 1 to 7)Biological
- Placebo for Corifollitropin AlfaDrug
- Placebo for RecFSH/Follitropin betaDrug
- 200 IU RecFSH/Follitropin beta (Days 8 to hCG)Biological
- GanirelixDrug
- hCGBiological
- ProgesteroneBiological
Arms2
Other
Mothers Corifollitropin Alfa 150 µg
Participants from the Base Trial P05787 who received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recombinant Follicle Stimulating Hormone (recFSH); followed by daily SC injections with 200 IU recFSH up to the day of human chorionogonadotropin (hCG); multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (5000 or 10,000 IU/USP) was administered when 3 follicles \>= 17 mm were observed; and on the day of oocyte pick up (OPU) daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
Other
Mothers recFSH 200 IU
Participants from the Base Trial P05787 who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (5000 or 10,000 IU/USP) was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored.
Primary outcomes6
Outcomes the sponsor listed as primary.
Number of Mothers in Current Follow Up Trial Experiencing Adverse Events (AEs)
Time frame · Up to one day following delivery (up to 1 year)
Registry description
An AE is any untoward medical occurrence in a trial participant administered a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including laboratory finding), symptom, or disease temporally associated with the use of investigational medicinal product.
Number of Mothers in Current Follow Up Trial Experiencing Serious AEs (SAEs)
Time frame · Up to one day following delivery (up to 1 year)
Registry description
A SAE is any untoward medical occurrence that at any dose resulted in the following: death, was life threatening, required in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.
Number of Infants Born in Current Follow Up Trial Experiencing AEs
Time frame · Up to 12 weeks following delivery (up to 1 year)
Registry description
An AE is any untoward medical occurrence in a trial participant administered a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including laboratory finding), symptom, or disease temporally associated with the use of investigational medicinal product.
Number of Infants in Current Follow Up Trial Experiencing SAEs
Time frame · Up to 12 weeks following delivery (up to 1 year)
Registry description
A SAE is any untoward medical occurrence that at any dose resulted in the following: death, was life threatening, required in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.
Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants in the Base Trial.
Time frame · At least 10 weeks after embryo transfer in Base Trial P05787 up to birth in current follow up Trial (up to 1 year)
Registry description
The take-home baby rate is 100 X the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800), from the Intent-to-Treat (ITT) group, with at least one live born infant relative to the number of participants in the Base Trial.
Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants From the Base Trial With Embryo Transfer.
Time frame · At least 10 weeks after embryo transfer in Base Trial P05787 up to birth in current Follow Up Trial (up to 1 year)
Registry description
The take-home baby rate is 100 X the number of participants with an ongoing pregnancy in Base Trial P05787 (NCT00696800), from the ITT group, with at least one live born infant relative to the number of participants from the Base Trial with embryo transfer.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeNumber· Up to one day following delivery (up to 1 year)
Number of Mothers in Current Follow Up Trial Experiencing Serious AEs (SAEs)
| Group | Value (Participants) |
|---|---|
| Mothers Corifollitropin Alfa 150 µg | 129 |
| Mothers recFSH 200 IU | 117 |
Primary outcomeNumber· Up to 12 weeks following delivery (up to 1 year)
Number of Infants Born in Current Follow Up Trial Experiencing AEs
| Group | Value (Participants) |
|---|---|
| Infants Corifollitropin Alfa 150 µg | 164 |
| Infants recFSH 200 IU | 161 |
Primary outcomeNumber· Up to 12 weeks following delivery (up to 1 year)
Number of Infants in Current Follow Up Trial Experiencing SAEs
| Group | Value (Participants) |
|---|---|
| Infants Corifollitropin Alfa 150 µg | 106 |
| Infants recFSH 200 IU | 94 |
Primary outcomeNumber· At least 10 weeks after embryo transfer in Base Trial P05787 up to birth in current follow up Trial (up to 1 year)
Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants in the Base Trial.
| Group | Value (Percentage of Participants) |
|---|---|
| Mothers Corifollitropin Alfa 150 µg | 35.6 |
| Mothers recFSH 200 IU | 34.4 |
Primary outcomeNumber· At least 10 weeks after embryo transfer in Base Trial P05787 up to birth in current Follow Up Trial (up to 1 year)
Percentage of Mothers From the Base Trial P05787 With at Least One Live Born Infant (Take-home Baby Rate) Relative to the Number of Participants From the Base Trial With Embryo Transfer.
| Group | Value (Percentage of Participants) |
|---|---|
| Mothers Corifollitropin Alfa 150 µg | 40.0 |
| Mothers recFSH 200 IU | 36.6 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Mothers Corifollitropin Alfa 150 µgParticipants from the Base Trial P05787 (NCT00696800) who received a SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; a single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored. | – | 129 / 274 | 112 / 274 |
| Mothers recFSH 200 IUParticipants from the Base Trial P05787 (NCT00696800) who received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix from Stimulation Day 5 to the day of hCG; single dose of hCG (10,000 or 5,000 IU/USP) was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses. Eligible participants from the Base Trial were enrolled in Follow Up Trial P05712, where no study treatments were given, and pregnancy, delivery and neonatal outcome were monitored. | – | 117 / 267 | 118 / 267 |
| Fetuses/Infants Corifollitropin Alfa 150 µgFetuses and infants born in Follow Up Trial P05712 to mothers treated with Corifollitropin Alfa 150 µg in Base Trial P05787 (NCT00696800) | – | 106 / 352 | 37 / 352 |
| Fetuses/Infants recFSH 200 IUFetuses and infants born in Follow Up Trial P05712 to mothers treated with recFSH 200 IU in Base Trial P05787 (NCT00696800) | – | 94 / 326 | 41 / 326 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- DerivedBonduelle M, Mannaerts B, Leader A, Bergh C, Passier D, Devroey P. Prospective follow-up of 838 fetuses conceived after ovarian stimulation with corifollitropin alfa: comparative and overall neonatal outcome. Hum Reprod. 2012 Jul;27(7):2177-85. doi: 10.1093/humrep/des156. Epub 2012 May 15. PMID 22587997
- DerivedBoostanfar R, Mannaerts B, Pang S, Fernandez-Sanchez M, Witjes H, Devroey P; Engage Investigators. A comparison of live birth rates and cumulative ongoing pregnancy rates between Europe and North America after ovarian stimulation with corifollitropin alfa or recombinant follicle-stimulating hormone. Fertil Steril. 2012 Jun;97(6):1351-8. doi: 10.1016/j.fertnstert.2012.02.038. Epub 2012 Mar 28. PMID 22459628
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 18 Years up to 36 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Participants who received at least one dose of either Corifollitropin Alfa or
Puregon®/Follistim® AQ Cartridge in Base Trial P05787 (NCT00696800);
* Ongoing pregnancy confirmed by ultrasound at least 10 weeks after embryo transfer in Base Trial P05787 (NCT00696800);
* Able and willing to give written informed consent.
Exclusion Criteria:
* None
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