Effect of GnRH Antagonist vs Agonist Long on IVF Outcome, Peak Estradiol Level,and Duration of Stimulation
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.
1 other identifier
interventional
43
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 9, 2012
CompletedFirst Posted
Study publicly available on registry
August 21, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedJune 4, 2014
June 1, 2014
1.8 years
August 9, 2012
June 3, 2014
Conditions
Outcome Measures
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.
One year
Secondary Outcomes (2)
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
Study Arms (2)
Bravelle & Menopur Agonist Long Protocol
ACTIVE COMPARATORPatients 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
ACTIVE COMPARATORPatients 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.
Interventions
Bravelle and Menopur are used for controlled ovarian stimulation (COH)
Agonist (Lupron) is used to suppress endogenous pituitary LH for the premature LH surges.
Ganirelix acetate or cetrorelix acetate Agonist is used to suppress endogenous pituitary LH for the premature LH surges.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Smokers
- Polycystic Ovarian Disease
- Endometriosis greater than Stage I
- Testicular aspirated sperm
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Main Line Fertility Centerlead
- Ferring Pharmaceuticalscollaborator
Study Sites (1)
Main Line Fertility Center
Bryn Mawr, Pennsylvania, 19010, United States
Related Publications (4)
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.
BACKGROUNDLudwig 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. doi: 10.1007/s00404-001-0267-2.
PMID: 11789740BACKGROUNDFluker 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. doi: 10.1016/s0015-0282(00)01638-1.
PMID: 11163814BACKGROUNDLudwig M, Felberbaum RE, Devroey P, Albano C, Riethmuller-Winzen H, Schuler 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. doi: 10.1007/pl00007479.
PMID: 10985616BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael J Glassner, M.D.
Main Line Fertility Center
- STUDY DIRECTOR
Sharon H. Anderson, Ph.D
Main Line Fertility Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2012
First Posted
August 21, 2012
Study Start
July 1, 2012
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
June 4, 2014
Record last verified: 2014-06