Trial | NCT01669291  Report issue

Title

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.

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    43
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.
No detailed description
Study Started
Jul 31
2012
Primary Completion
May 31
2014
Study Completion
May 31
2014
Last Update
Jun 04
2014
Estimate

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.

  • Other names: Leuprolide Acetate, Lupron

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

Bravelle & Menopur Agonist Long Protocol Active Comparator

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.

Bravelle & Menopur Antagonist Protocol Active Comparator

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.

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
No Results Posted