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

Not Applicable

Completed

• Conditions: Fertility
• Interventions: Drug: Bravelle and Menopur; Drug: Agonist; Drug: Antagonist

• Registration Number: NCT01669291
• Lead Sponsor: Main Line Fertility Center

Brief 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.

Detailed Description

No detailed description

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-08-09
• Study First Submitted QC: 2012-08-16
• Study First Posted: 2012-08-21
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-03
• Last Update Posted: 2014-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 43

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bravelle & Menopur Agonist Long Protocol	Bravelle and Menopur	Patients will use an LH agonist (Lupron) starting on day 18 of the oral contraceptive pill (OCP), 5 units b.i.d. followed by 5 units q.d. beginning on day one of stimulation medications. The 5 units q.d. dose will continue until the day of hCG administration.Patients will administer Bravelle and Menopur for ovarian stimulation.
Bravelle & Menopur Agonist Long Protocol	Agonist	Patients will use an LH agonist (Lupron) starting on day 18 of the oral contraceptive pill (OCP), 5 units b.i.d. followed by 5 units q.d. beginning on day one of stimulation medications. The 5 units q.d. dose will continue until the day of hCG administration.Patients will administer Bravelle and Menopur for ovarian stimulation.
Bravelle & Menopur Antagonist Protocol	Bravelle and Menopur	Patients will complete standard dose of oral contraceptive pill (OCP) and will then administer GnRH antagonist (ganirelix acetate or cetrorelix acetate) 0.25 mg q.d. during the stimulation phase when the lead follicle size reaches 12mm. The antagonist will continue until the day of hCG administration. Patients will administer Bravelle and Menopur for ovarian stimulation.
Bravelle & Menopur Antagonist Protocol	Antagonist	Patients will complete standard dose of oral contraceptive pill (OCP) and will then administer GnRH antagonist (ganirelix acetate or cetrorelix acetate) 0.25 mg q.d. during the stimulation phase when the lead follicle size reaches 12mm. The antagonist will continue until the day of hCG administration. Patients will administer Bravelle and Menopur for ovarian stimulation.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
To determined if COH in IVF patients using Bravelle & Menopur with antagonists results in lower peak estradiol levels compared to agonist	One year
To determine if COH patients using Bravelle & Menopur with antagonist antagonists results inn shorter period of stimulation compared with agonist.	One year

Trial Locations

Locations (1)

Main Line Fertility Center; 🇺🇸 Bryn Mawr, Pennsylvania, United States