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Investigate Dose of Org 36286 to Initiate Multiple Follicular Growth in a Controlled Ovarian Hyperstimulation Protocol for IVF or IVF/ICSI (P07015)

NCT00702806 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2024-08-15

No results posted yet for this study

Summary

The primary objective of this trial was to investigate the appropriate dose of a single injection of Org 36286 to initiate multifollicular growth for the first seven days in a controlled ovarian hyperstimulation (COH) protocol for IVF and IVF/ICSI. After seven days, participants were converted to treatment with Puregon® 150 IU and administration of the GnRH antagonist Orgalutran® to finalize the stimulation cycle. Secondary objectives were the safety (including the absence of antibody formation) and the direct effects of Org 36286 on reproductive functions (steroidogenesis, oocyte maturation, embryo quality and implantation).

Conditions

Interventions

DRUG

Org 36286

Intra-abdominal injection of Org 36286

DRUG

Puregon®

Subcutaneous Puregon® 150 IU

DRUG

Orgalutran®

Subcutaneous Orgalutran® 0.25 mg

DRUG

Pregnyl®

Subcutaneous Pregnyl® 10,000 IU

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2001-07-01
Primary Completion
2002-10-15
Completion
2002-10-15

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Entities

Diseases

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 NCT00702806 on ClinicalTrials.gov