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Trial · Interventional

CompletedNot applicableRegistry data

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

NCTNCT01669291 (opens ClinicalTrials.gov in a new tab)Other idMLFC-003
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
43 participants (actual)
Sponsor
Main Line Fertility Center · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Jul 2012
Primary completion
May 2014
Completion
May 2014
First posted
21 Aug 2012 (estimated)
Last update posted
4 Jun 2014 (estimated)
Conditions
Fertility

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2012201320142015
  1. N/A

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

    NCT01669291

    Jul 2012 to May 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Bravelle and MenopurDrug
  • AgonistDrug
  • AntagonistDrug

Arms2

  • Active comparator

    Bravelle & Menopur Agonist Long Protocol

    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.

  • Active comparator

    Bravelle & Menopur Antagonist Protocol

    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 outcomes1

Outcomes the sponsor listed as primary.

  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(2)

  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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2001

7 results

Efficacy and safety of ganirelix acetate versus leuprolide acetate in women undergoing controlled ovarian hyperstimulation.

Fluker et al. 2001Fertility and sterilitycited by 160

PMID 11163814DOI 10.1016/s0015-0282(00)01638-1PUB-11163814

Full text at the publisher7 results
Publisher pageSee results (7)

Indexing hint: Randomized controlled trial · 2000

6 results

Significant reduction of the incidence of ovarian hyperstimulation syndrome (OHSS) by using the LHRH antagonist Cetrorelix (Cetrotide) in controlled ovarian stimulation for assisted reproduction.

Ludwig et al. 2000Archives of gynecology and obstetricscited by 60

PMID 10985616DOI 10.1007/pl00007479PUB-10985616

Full text at the publisher6 results
Publisher pageSee results (6)

More studies

1 study on this page

Indexing hint: Meta-analysis (pooled) · 2001

Use of GnRH antagonists in ovarian stimulation for assisted reproductive technologies compared to the long protocol. Meta-analysis.

Ludwig et al. 2001Archives of gynecology and obstetricscited by 87

PMID 11789740DOI 10.1007/s00404-001-0267-2PUB-11789740

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
Female
Age
from 21 Years up to 40 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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