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OpenTrials
Completed

NCT Number: NCT01669291

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

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.

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Key information

Conditions

Age range

21 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Main Line Fertility Center

Bryn Mawr, Pennsylvania, 19010, United States

About this study

No detailed description

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bravelle and Menopur

Drug

Bravelle and Menopur are used for controlled ovarian stimulation (COH)

Agonist

Drug

Agonist (Lupron) is used to suppress endogenous pituitary LH for the premature LH surges.

Other names: Leuprolide Acetate, Lupron

Antagonist

Drug

Ganirelix acetate or cetrorelix acetate Agonist is used to suppress endogenous pituitary LH for the premature LH surges.

Other names: ganirelix acetate, cetrorelix acetate

Primary outcomes

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

    Time frame: One year

Secondary outcomes

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

    Time frame: One year

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

    Time frame: One year

Sponsors and collaborators

Lead sponsor

Main Line Fertility Center

Other

Collaborators

  • Ferring Pharmaceuticals

Registry information

Official study 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.

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 21, 2012
Registry last updated
Jun 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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