Clinical Trials Logo
  1. Home
  2. In Vitro Fertilization
  3. NCT00696800

A Study to Investigate the Efficacy and Safety of a Single Injection of Corifollitropin Alfa (Organon 36286) for Ovarian Stimulation Using Daily Recombinant Follicle Stimulating Hormone (FSH) as Reference (P05787)

In Vitro Fertilization Clinical Trial

Official title:
A Phase III, Randomized, Double-Blind, Active-Controlled, Non-Inferiority Clinical Trial to Investigate the Efficacy and Safety of a Single Injection of Org 36286 (Corifollitropin Alfa) to Induce Multifollicular Development for Controlled Ovarian Stimulation Using Daily Recombinant FSH as Reference

Clinical Trial Summary

To investigate the efficacy and safety of a single injection of 150 μg Corifollitropin Alfa (Organon 36286) to induce multifollicular development for controlled ovarian stimulation using daily recombinant FSH (recFSH) as a reference. The primary hypothesis is that a single injection of Corifollitropin Alfa is non-inferior to daily treatment with recFSH in initiating multifollicular growth.

Clinical Trial Description

This is a randomized, double-blind, active-controlled, non-inferiority clinical trial investigating the efficacy and safety of a new treatment regimen with Corifollitropin Alfa, a recombinant gonadotropin applied to initiate and sustain follicular stimulation in controlled ovarian stimulation for Assisted Reproductive Technology (ART). For this regimen, participants receive a single injection of Corifollitropin Alfa and one week later, treatment is continued with daily recFSH up to the day of triggering final oocyte maturation. In the reference group participants receive daily injections of recFSH up to the day of triggering final oocyte maturation. Non-inferiority in ongoing pregnancy rates (assessed at least 10 weeks after embryo transfer) will be the primary endpoint for this trial. The number of oocytes retrieved will be analyzed as co-primary endpoint. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00696800
Study type Interventional
Source Organon and Co
Contact
Status Completed
Phase Phase 3
Start date June 27, 2006
Completion date January 15, 2008
View Details
See also
  Status Clinical Trial Phase
Completed NCT00696878 - Corifollitropin Alfa in Participants Undergoing Repeated Controlled Ovarian Stimulation (COS) Cycles Using a Multiple Dose Gonadatropin Releasing Hormone (GnRH) Antagonist Protocol (Study 38825)(P05714) Phase 3
Recruiting NCT04122729 - N680S Polymorphism of the FSHR Gene and Its Relationship With the Type of Gonadotropin Used in COS
Not yet recruiting NCT02534857 - A Study Comparing a Shorter Exposure of Oocyte to Spermatozoa Versus a Standard Incubation on the Live Birth Rate of In-vitro Fertilization Treatment N/A
Recruiting NCT01406600 - Optimal rhCG(Ovidrel®) Dose in Poor Responder During IVF and ICSI Cycles N/A
Completed NCT01406028 - Does Emotional Support Decrease In Vitro Fertilization Stress? N/A
Withdrawn NCT00541892 - Sibling Oocyte Study of Medium for In Vitro Fertilization/Intracytoplasmic Sperm Injection (IVF/ICSI) With no Human Serum Albumine Phase 2
Completed NCT00708383 - in Vitro Fertilization (IVF) Media Protein and Live Birth Rates N/A
Completed NCT03627533 - The Differences of Oocyte Maturation, Granulosa Cell Apoptosis Index Between Electroacupuncture And Sham Groups IVF N/A
Recruiting NCT04160611 - What Amount of Stress is Enough for a Successful Conception? Phase 3
Suspended NCT01600794 - To Evaluate The Anrogens and Ovary Function in In Vitro Fertilization N/A
Completed NCT01507376 - Comparing the Efficacy of Urinary and Recombinant Human Chorionic Gonadotropin (hCG) on Oocyte Maturity Phase 3
Terminated NCT00866008 - A Study of the Effects of a Novel Ovarian Stimulation Regimen on Embryo Aneuploidy Rates in In Vitro Fertilization (IVF) Phase 4
Recruiting NCT04082650 - Vitamin D and Pregnancy Outcome in PCOS Patients N/A
Recruiting NCT03758833 - eSET or eDET Associated to PGT in IVF N/A
Not yet recruiting NCT04407871 - Acupuncture and Chinese Herbal Medicine to Improve Live Birth Rate of in Vitro Fertilization (IVFAct) N/A
Recruiting NCT03345030 - The Role of DNA Damage of Granulosa Cell on Oocyte Quality and in Vitro Fertilization Outcome N/A
Not yet recruiting NCT06367985 - CAPA-IVM Culture With Low Oxygen Tension N/A
Not yet recruiting NCT03090438 - IVF Outcomes After Varicocele Repair N/A
Terminated NCT01614067 - Delayed Start to Ovarian Stimulation Phase 4
Completed NCT01343992 - Bed Rest or no Bed Rest? N/A