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

Main Line Fertility Center

Status: Completed

Conditions: Fertility

Treatments: Drug: Bravelle and Menopur; Drug: Agonist; Drug: Antagonist

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01669291

MLFC-003

Details and patient eligibility

About

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.

Full description

No detailed description

Enrollment: 43 patients

Sex: Female

Ages: 21 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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43 participants in 2 patient groups

Bravelle & Menopur Agonist Long Protocol

Active Comparator group

Description:

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.

Treatment:

Drug: Bravelle and Menopur

Drug: Agonist

Bravelle & Menopur Antagonist Protocol

Active Comparator group

Description:

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.

Treatment:

Drug: Antagonist

Drug: Bravelle and Menopur