Effect of GnRH Antagonist vs Agonist Long on IVF Outcome, Peak Estradiol Level,and Duration of Stimulation
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|ClinicalTrials.gov Identifier: NCT01669291|
Recruitment Status : Completed
First Posted : August 21, 2012
Last Update Posted : June 4, 2014
|Condition or disease||Intervention/treatment|
|Fertility||Drug: Bravelle and Menopur Drug: Agonist Drug: Antagonist|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||July 2012|
|Primary Completion Date :||May 2014|
|Study Completion Date :||May 2014|
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)Drug: Agonist
Agonist (Lupron) is used to suppress endogenous pituitary LH for the premature LH surges.
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)Drug: Antagonist
Ganirelix acetate or cetrorelix acetate Agonist is used to suppress endogenous pituitary LH for the premature LH surges.
- 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 ]
- 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 ]
- To determine if COH patients using Bravelle & Menopur with antagonist antagonists results inn shorter period of stimulation compared with agonist. [ Time Frame: One year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01669291
|United States, Pennsylvania|
|Main Line Fertility Center|
|Bryn Mawr, Pennsylvania, United States, 19010|
|Principal Investigator:||Michael J Glassner, M.D.||Main Line Fertility Center|
|Study Director:||Sharon H. Anderson, Ph.D||Main Line Fertility Center|