Primary outcomeNumber· Up to 1 Year
Number of Expectant Mothers Experiencing Adverse Events (AEs)
| Group | Value (Participants) |
|---|---|
| Expectant Mothers Administered Corifollitropin Alpha 100 ug | 7 |
| Expectant Mothers Administered Corifollitropin Alpha 150 ug | 6 |
Trial · Observational
CompletedPhase not statedResults postedRegistry dataPregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial 38833 (P05783)
Short name Care
NCTNCT00702520 (opens ClinicalTrials.gov in a new tab)Other idP05783Other id38834Other idMK-8962-010Other id2005-000062-40
Overview
- Status
- Completed
- Phase
- Phase not stated
- Enrollment
- 15 participants (actual)
- Sponsor
- Organon and Co · Industry
- Design
- Not stated
- Countries
- Not stated
- Start
- 1 Apr 2006
- Primary completion
- 7 Nov 2007
- Completion
- 15 Jan 2008
- First posted
- 20 Jun 2008 (estimated)
- Last update posted
- 5 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
2006200720082009
- Ph –
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The objective of this trial is to evaluate whether corifollitropin alfa (MK-8962, Org 36286) 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) is safe for pregnant participants and their offspring.
Interventions
- Corifollitropin alpha (MK-8962, Org 36286) 100 ugDrug
- Corifollitropin alpha (MK-8962, Org 36286) 150 ugDrug
- TriptorelinDrug
- Recombinant follicle stimulating hormone (recFSH)Biological
- Human chorionic gonadotprophin (hCG).Biological
Arms2
Other
Corifollitropin alpha 100 ug
In the base study (P05788, 38833, NCT00702351), participants were pre-treated with daily subcutaneous (SC) injections of 0.1 mg triptorelin started between Day 21 and 24 of the menstrual cycle (mid luteal phase). After suppression of endogenous luteinizing hormone (LH) and follicle stimulating hormone (FSH) was confirmed by estradiol (E2) and progesterone (P) measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing \<= 60 kg. From stimulation Day 8 onwards, treatment was continued with daily SC of recombinant follicle stimulating hormone (recFSH) injections (maximally 200 IU) up to and including the day of administration of human chorionic gonadotprophin (hCG). No study medications were administered in the present P05783 study (38834, NCT00702520).
Other
Corifollitropin alpha 150 ug
In the base study (P05788, 38833, NCT00702351), participants were pre-treated with daily SC injections of 0.1 mg triptorelin started between Day 21 and 24 of the menstrual cycle (mid luteal phase). After suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing \>= 50 kg. From stimulation Day 8 onwards, treatment was continued with daily SC of recFSH injections (maximally 200 IU) up to and including the day of administration of hCG. No study medications were administered in the present P05783 study (38834, NCT00702520).
Primary outcomes5
Outcomes the sponsor listed as primary.
Number of Expectant Mothers Experiencing Adverse Events (AEs)
Time frame · Up to 1 Year
Registry description
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug.
Number of Expectant Mothers Experiencing Serious AEs (SAEs)
Time frame · Up to 1 Year
Registry description
An AE or suspected adverse reaction is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Number of Infants Experiencing AEs
Time frame · Up to 1 Year
Registry description
An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug.
Number of Infants Experiencing SAEs
Time frame · Up to 1 Year
Registry description
An AE or suspected adverse reaction is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Take-Home Baby Rate
Time frame · Birth of a one or more live babies (Up to 1 year)
Registry description
The take-home baby rate was calculated as the number of participants with a least one live born infant in the follow-up study (P05783, 38834, NCT00702520) relative to the number of participants treated with Corifollitropin alpha in the base study (P05788, 38833, NCT00702351).
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 1 Year
Number of Expectant Mothers Experiencing Serious AEs (SAEs)
| Group | Value (Participants) |
|---|---|
| Expectant Mothers Administered Corifollitropin Alpha 100 ug | 2 |
| Expectant Mothers Administered Corifollitropin Alpha 150 ug | 2 |
Primary outcomeNumber· Up to 1 Year
Number of Infants Experiencing AEs
| Group | Value (Participants) |
|---|---|
| Infants From Mothers Administered Corifollitropin Alpha 100 ug | 6 |
| Infants From Mothers Administered Cori. Alpha 150 ug | 11 |
Primary outcomeNumber· Up to 1 Year
Number of Infants Experiencing SAEs
| Group | Value (Participants) |
|---|---|
| Infants From Mothers Administered Corifollitropin Alpha 100 ug | 6 |
| Infants From Mothers Administered Cori. Alpha 150 ug | 7 |
Primary outcomeNumber· Birth of a one or more live babies (Up to 1 year)
Take-Home Baby Rate
| Group | Value (Percentage of participants) |
|---|---|
| Expectant Mothers Administered Corifollitropin Alpha 100 ug | 28.0 |
| Expectant Mothers Administered Corifollitropin Alpha 150 ug | 33.3 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Expectant Mothers Administered Corifollitropin Alpha 100 ugIn the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing \<= 60 kg. No study medications were administered in the P05783 study (38834, NCT00702520). | – | 2 / 7 | 7 / 7 |
| Expectant Mothers Administered Corifollitropin Alpha 150 ugIn the base study (P05788, 38833, NCT00702351), after suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing \>= 50 kg. No study medications were administered in the follow-up P05783 study. | – | 2 / 8 | 6 / 8 |
| Fetuses/Infants From Mothers Administered Cori. Alpha 100 ugFetuses/Infants from mothers who received 100 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520) according to standard practice. No study medications were administered in the follow-up P05783 study. | – | 6 / 8 | 5 / 8 |
| Fetuses/Infants From Mothers Administered Cori. Alpha 150 ugFetuses/Infants from mothers who received 150 ug corifollitropin alfa in the base study (P05788, 38833, NCT00702351), were followed for safety and efficacy in the current follow-up study (P05783, 38834, NCT00702520) according to standard practice. No study medications were administered in the follow-up P05783 study. | – | 7 / 11 | 11 / 11 |
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
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 18 Years up to 39 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Participants who received one dose of corifollitropin alfa in Trial 38833;
* Ongoing pregnancy confirmed by ultrasound at least 10 weeks after embryo transfer in Trial 38833;
* Able and willing to give written informed consent.
Exclusion Criteria:
* None
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