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Corifollitropin Alfa in Participants Undergoing Repeated Controlled Ovarian Stimulation (COS) Cycles Using a Multiple Dose Gonadatropin Releasing Hormone (GnRH) Antagonist Protocol (Study 38825)(P05714)

NCT00696878 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 682

Last updated 2024-06-18

Study results available
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Summary

The objective of the trial is to assess the non-immunogenicity and safety of corifollitropin alfa (also known as Org 36286, SCH 900962 and MK-8962) in participants undergoing repeated COS cycles using a multiple dose GnRH antagonist protocol.

Conditions

  • In Vitro Fertilization

Interventions

DRUG

Corifollitropin alfa

Corifollitropin alfa 150 µg administered as a single subcutaneous dose.

BIOLOGICAL

FSH

FSH administerd subcutaneously at a dose not to exceed 225 IU/day.

BIOLOGICAL

GnRH antagonist

GnRH antagonist administered subcutaneously at a dose of 0.25 mg/day.

BIOLOGICAL

(rec)hCG

(rec)hCG administered subcutaneously at a dose of 5,000-10,000 IU/250 µg.

DRUG

Progesterone

Progesterone administered vaginally at a dose of at least 600 mg/day.

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2006-09-26
Primary Completion
2009-02-17
Completion
2009-05-15

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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 NCT00696878 on ClinicalTrials.gov