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Optimizing Ovulation Induction in the Poor Responder

NCT01200537 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2012-11-21

No results posted yet for this study

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.

Conditions

  • IVF Poor Responders

Interventions

DRUG

Estradiol

This group of patients will receive estradiol patches prior to the IVF cycle.

DRUG

Oral Contraceptive Pills (OCP)

This group of patients will receive OCP's prior to the IVF cycle.

Sponsors & Collaborators

Principal Investigators

  • Susannah D Copland, MD · Duke University

  • Donna Sessions, MD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-10-31
Completion
2012-10-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01200537 on ClinicalTrials.gov