Trials / Completed
CompletedNCT00702520
Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial 38833 (P05783)
Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established After Controlled Ovarian Stimulation in Clinical Trial 38833 for Org 36286 (Corifollitropin Alfa)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 15 (actual)
- Sponsor
- Organon and Co · Industry
- Sex
- Female
- Age
- 18 Years – 39 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
This is a follow-up protocol to prospectively monitor pregnancy, delivery, and neonatal outcomes of all women who were treated with corifollitropin alfa and became pregnant during the base Trial 38833. For this follow-up trial (38834), no investigational products will be administered and no study specific assessments are required, but information will be obtained as per standard clinical practice.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Corifollitropin alpha (MK-8962, Org 36286) 100 ug | Subcutaneous administration of corifollitropin alpha at a dose of 100 ug |
| DRUG | Corifollitropin alpha (MK-8962, Org 36286) 150 ug | Subcutaneous administration of corifollitropin alpha at a dose of 150 ug |
| DRUG | Triptorelin | Daily SC injections of 0.1 mg triptorelin started between Day 21 and 24 of the menstrual cycle (mid luteal phase). |
| BIOLOGICAL | Recombinant follicle stimulating hormone (recFSH) | 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. |
| BIOLOGICAL | Human chorionic gonadotprophin (hCG). | HCG was administered as a single subcutaneous injection of 5,000 to 10,000 international units. |
Timeline
- Start date
- 2006-04-01
- Primary completion
- 2007-11-07
- Completion
- 2008-01-15
- First posted
- 2008-06-20
- Last updated
- 2024-09-05
- Results posted
- 2014-06-20
Source: ClinicalTrials.gov record NCT00702520. Inclusion in this directory is not an endorsement.