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Effect of GnRH Antagonist vs Agonist Long on IVF Outcome, Peak Estradiol Level,and Duration of Stimulation

Information source: Main Line Fertility Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Fertility

Intervention: Bravelle and Menopur (Drug); Agonist (Drug); Antagonist (Drug)

Phase: N/A

Status: Completed

Sponsored by: Main Line Fertility Center

Official(s) and/or principal investigator(s):
Michael J Glassner, M.D., Principal Investigator, Affiliation: Main Line Fertility Center
Sharon H. Anderson, Ph.D, Study Director, Affiliation: Main Line Fertility Center

Summary

The purpose of this study is to determine if utilizing GnRH antagonists versus agonist long protocol during controlled ovarian stimulation (COH) with human-derived gonadotropins for assisted reproduction affects IVF outcome, peak estradiol level, and duration of stimulation.

Clinical Details

Official title: Effect of GnRH Antagonist Protocol vs Agonist Long Protocol During Controlled Hyperstimulation (COH)for Assisted Reproduction on IVF Outcome, Peak Estradiol Level, and Duration of Stimulation.

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To determine if COH in IVF patients using Bravelle & Menopur with antagonists results in improved or equal IVF results compared to patients using agonist.

Secondary outcome:

To determined if COH in IVF patients using Bravelle & Menopur with antagonists results in lower peak estradiol levels compared to agonist

To determine if COH patients using Bravelle & Menopur with antagonist antagonists results inn shorter period of stimulation compared with agonist.

Detailed description: No detailed description

Eligibility

Minimum age: 21 Years. Maximum age: 40 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Ages 21-40 (inclusive up to 41)

- Day 2-4 FSH < or equal to 10

- Antimullerian Hormone (AMH) greater than or equal to 1. 0

- Between 5 and 20 antral follicles on day 2-4

- Body Mass Index (BMI)>or equal to 18 and < or equal to 32

Exclusion Criteria:

- Smokers

- Polycystic Ovarian Disease

- Endometriosis greater than Stage I

- Testicular aspirated sperm

Locations and Contacts

Main Line Fertility Center, Bryn Mawr, Pennsylvania 19010, United States
Additional Information

Related publications:

Ludwig, Michael. GnRH antagonists. Textbook of Assisted Reproductive Technologies - Laboratory and Clinical Perspectives. Third edition. Edited by Gardner, D, Weissman, A, Howles, C, Shoham, Z. 2009: 539-552.

Ludwig M, Katalinic A, Diedrich K. Use of GnRH antagonists in ovarian stimulation for assisted reproductive technologies compared to the long protocol. Meta-analysis. Arch Gynecol Obstet. 2001 Nov;265(4):175-82.

Fluker M, Grifo J, Leader A, Levy M, Meldrum D, Muasher SJ, Rinehart J, Rosenwaks Z, Scott RT Jr, Schoolcraft W, Shapiro DB; North American Ganirelix Study Group. Efficacy and safety of ganirelix acetate versus leuprolide acetate in women undergoing controlled ovarian hyperstimulation. Fertil Steril. 2001 Jan;75(1):38-45.

Ludwig M, Felberbaum RE, Devroey P, Albano C, Riethmüller-Winzen H, Schüler A, Engel W, Diedrich K. Significant reduction of the incidence of ovarian hyperstimulation syndrome (OHSS) by using the LHRH antagonist Cetrorelix (Cetrotide) in controlled ovarian stimulation for assisted reproduction. Arch Gynecol Obstet. 2000 Jul;264(1):29-32.

Starting date: July 2012
Last updated: June 3, 2014

Page last updated: August 23, 2015

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