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

This study has been completed.
Sponsor:
Collaborator:
Ferring Pharmaceuticals
Information provided by (Responsible Party):
Main Line Fertility Center
ClinicalTrials.gov Identifier:
NCT01669291
First received: August 9, 2012
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Fertility
Drug: Bravelle and Menopur
Drug: Agonist
Drug: Antagonist

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Main Line Fertility Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • To determine if COH patients using Bravelle & Menopur with antagonist antagonists results inn shorter period of stimulation compared with agonist. [ Time Frame: One year ] [ Designated as safety issue: No ]

Enrollment: 43
Study Start Date: July 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Bravelle and Menopur
Bravelle and Menopur are used for controlled ovarian stimulation (COH)
Other Name: Bravelle and Menopur
Drug: Agonist
Agonist (Lupron) is used to suppress endogenous pituitary LH for the premature LH surges.
Other Names:
  • Leuprolide Acetate
  • Lupron
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.
Drug: Bravelle and Menopur
Bravelle and Menopur are used for controlled ovarian stimulation (COH)
Other Name: Bravelle and Menopur
Drug: Antagonist
Ganirelix acetate or cetrorelix acetate Agonist is used to suppress endogenous pituitary LH for the premature LH surges.
Other Names:
  • ganirelix acetate
  • cetrorelix acetate

Detailed Description:

No detailed description

  Eligibility

Ages Eligible for Study:   21 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01669291

Locations
United States, Pennsylvania
Main Line Fertility Center
Bryn Mawr, Pennsylvania, United States, 19010
Sponsors and Collaborators
Main Line Fertility Center
Ferring Pharmaceuticals
Investigators
Principal Investigator: Michael J Glassner, M.D. Main Line Fertility Center
Study Director: Sharon H. Anderson, Ph.D Main Line Fertility Center
  More Information

Publications:
Responsible Party: Main Line Fertility Center
ClinicalTrials.gov Identifier: NCT01669291     History of Changes
Other Study ID Numbers: MLFC-003
Study First Received: August 9, 2012
Last Updated: June 3, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Estradiol
Ganirelix
Cetrorelix
Menotropins
Leuprolide
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Therapeutic Uses
Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 28, 2014