Optimizing Ovulation Induction in the Poor Responder

• Status: Withdrawn
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this randomized controlled trial is to compare the efficacy and effect of luteal estradiol and combined oral contraceptive pills (COPC) on follicle recruitment and synchrony in a poor responder population. The randomized groups consist of: 1. patients receiving luteal estradiol prior to ovulation induction; and 2. patients receiving COCPs for 1 month prior to ovulation induction. Follicle characteristics and serum biomarkers will be followed and compared in each group. Coefficient of variation will be used to evaluate follicle size discrepancy. Chi square analysis will be used to compare categorical variables between treatment groups. Both estradiol and COPCs are used clinically in assisted reproduction, so this study affords no additional risks to the participants.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Duke University
• Collaborator: Emory University
• Treatments: Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Norinyl; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• Antral follicle count < 8

• Antimullerian hormone (AMH) <1.3

• Follicle stimulating hormone (FSH)>10

• History of follicular dysynchrony or poor response

Exclusion Criteria:

• Menopause

• FSH >40

• Age > 50

• Contraindication to estradiol or COCP (including pre-existing cardiovascular disease, familial thrombophilia (factor V Leiden), severe hypercholesterolemia, smoker over age 35) Ovulation induction during month of estradiol treatment