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

Study Overview
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Brief Summary
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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.

Detailed Description
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No detailed description

Official Title
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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.

Conditions
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Fertility

Intervention / Treatment
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* Drug: Bravelle and Menopur
* Drug: Agonist
* Drug: Antagonist


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bravelle & Menopur Agonist Long Protocol<br>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<br>* Bravelle and Menopur are used for controlled ovarian stimulation (COH)<br>Drug: Agonist<br>* Agonist (Lupron) is used to suppress endogenous pituitary LH for the premature LH surges.<br>* Other names: Lupron;|
| Active Comparator: Bravelle & Menopur Antagonist Protocol<br>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<br>* Bravelle and Menopur are used for controlled ovarian stimulation (COH)<br>Drug: Antagonist<br>* Ganirelix acetate or cetrorelix acetate Agonist is used to suppress endogenous pituitary LH for the premature LH surges.<br>* Other names: cetrorelix acetate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |