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Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial 38833 (P05783)

NCT00702520 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2024-09-05

Study results available
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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.

Conditions

  • Pregnancy
  • Neonates

Interventions

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.

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-01
Primary Completion
2007-11-07
Completion
2008-01-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00702520 on ClinicalTrials.gov