Optimizing Ovulation Induction in the Poor Responder

This study has been withdrawn prior to enrollment.
(Change in staffing)
Sponsor:
Collaborator:
Emory University
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT01200537
First received: August 23, 2010
Last updated: November 19, 2012
Last verified: November 2012
  Purpose

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 Intervention
IVF Poor Responders
Drug: Estradiol
Drug: Oral Contraceptive Pills (OCP)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Follicular response and synchrony [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    We will measure follicular response and synchrony following adminstration of extradiol patches or oral contraceptive pills.


Secondary Outcome Measures:
  • IVF outcomes [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    We will compare IVF outcomes in the estradiol patch and OCP groups.


Enrollment: 0
Study Start Date: October 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01200537

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

Publications:

Responsible Party: Susannah Copland, MD, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT01200537     History of Changes
Other Study ID Numbers: Pro00022374
Study First Received: August 23, 2010
Last Updated: November 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
IVF
poor responders
follicle synchrony
IVF response
estrogen
estradiol (E2)
oral contraceptive pill (OCP)
birth control pill (BCP)

Additional relevant MeSH terms:
Contraceptive Agents
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Norinyl
Contraceptives, Oral
Contraceptives, Oral, Combined
Estradiol
Polyestradiol phosphate
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on July 24, 2014