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Optimizing Ovulation Induction in the Poor Responder

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ClinicalTrials.gov Identifier: NCT01200537
Recruitment Status : Withdrawn (Change in staffing)
First Posted : September 13, 2010
Last Update Posted : November 21, 2012
Emory University
Information provided by:
Duke University

Brief 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.

Condition or disease Intervention/treatment Phase
IVF Poor Responders Drug: Estradiol Drug: Oral Contraceptive Pills (OCP) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimizing Ovulation Induction in the Poor Responder: a Randomized Clinical Trial of Luteal Phase Estradiol Versus Combined Oral Contraceptive Pill on Ovarian Morphology and Biomarkers Prior to Ovulation Induction
Study Start Date : October 2010
Estimated Primary Completion Date : October 2011
Estimated Study Completion Date : October 2012

Arm Intervention/treatment
Active Comparator: Estradiol Patch
This group of patients will receive estradiol patches prior to the IVF cycle.
Drug: Estradiol
This group of patients will receive estradiol patches prior to the IVF cycle.
Other Names:
  • Vivelle-Dot
  • Climara

Active Comparator: Oral Contraceptive Pills (OCP)
This group of patients will receive OCP's prior to the IVF cycle.
Drug: Oral Contraceptive Pills (OCP)
This group of patients will receive OCP's prior to the IVF cycle.
Other Names:
  • Loestrin
  • Ortho-Novum

Primary Outcome Measures :
  1. Follicular response and synchrony [ Time Frame: 2 years ]
    We will measure follicular response and synchrony following adminstration of extradiol patches or oral contraceptive pills.

Secondary Outcome Measures :
  1. IVF outcomes [ Time Frame: 2 years ]
    We will compare IVF outcomes in the estradiol patch and OCP groups.

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01200537

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United States, North Carolina
Duke Fertility Center
Durham, North Carolina, United States, 27713
Sponsors and Collaborators
Duke University
Emory University
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Principal Investigator: Susannah D Copland, MD Duke University
Principal Investigator: Donna Sessions, MD Emory University

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Responsible Party: Susannah Copland, MD, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT01200537    
Other Study ID Numbers: Pro00022374
First Posted: September 13, 2010    Key Record Dates
Last Update Posted: November 21, 2012
Last Verified: November 2012
Keywords provided by Duke University:
poor responders
follicle synchrony
IVF response
estradiol (E2)
oral contraceptive pill (OCP)
birth control pill (BCP)
Additional relevant MeSH terms:
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Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents, Hormonal
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Hormonal