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

Fertility Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01669291
• Other study ID #: MLFC-003
• Status: Completed
• Phase: N/A
• First received: August 9, 2012
• Last updated: June 3, 2014
• Start date: July 2012
• Est. completion date: May 2014

Study information

• Verified date: June 2014
• Source: Main Line Fertility Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

No detailed description

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 40 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Fertility

Intervention

Drug:
• Bravelle and Menopur
Bravelle and Menopur are used for controlled ovarian stimulation (COH)
• Agonist
Agonist (Lupron) is used to suppress endogenous pituitary LH for the premature LH surges.
• Antagonist
Ganirelix acetate or cetrorelix acetate Agonist is used to suppress endogenous pituitary LH for the premature LH surges.

Locations

Country	Name	City	State
United States	Main Line Fertility Center	Bryn Mawr	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Main Line Fertility Center	Ferring Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine if COH in IVF patients using Bravelle & Menopur with antagonists results in improved or equal IVF results compared to patients using agonist.		One year	No
Secondary	To determined if COH in IVF patients using Bravelle & Menopur with antagonists results in lower peak estradiol levels compared to agonist		One year	No
Secondary	To determine if COH patients using Bravelle & Menopur with antagonist antagonists results inn shorter period of stimulation compared with agonist.		One year	No