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A Comparison of the Microdose Leuprolide Protocol vs. Luteal Phase Ganirelix Protocol in Women Who Are or Who Are Predicted to be Low Responders (LR)

This study has been completed.
Sponsor:
Information provided by:
University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT00633555
First received: March 4, 2008
Last updated: February 9, 2011
Last verified: February 2011
History of Changes
  Purpose

Patients who have undergone in vitro fertilization (IVF) and produced four or less follicles or had four or less oocytes (eggs) retrieved are often referred to as poor responders. We will refer to these patients from this point forward as "low responders" to avoid using a potentially offensive label. We are currently using 2 different IVF medication protocols in our practice to treat low responder patients with infertility: the "Microdose Leuprolide" protocol and the "Luteal Phase Ganirelix" protocol. We would like to conduct a randomized-controlled trial and randomize patients to one treatment group or the other to determine which medication protocol is more effective in treating infertility in this group of patients.


Condition
Infertility

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Randomized Controlled Trial of Microdose Leuprolide Protocol vs. Luteal Phase Ganirelix Protocol in Predicted Low Responders

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by University of Connecticut Health Center:

Primary Outcome Measures:
  • Implantation rate [ Time Frame: 4-6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of oocytes retrieved [ Time Frame: 4-6 weeks ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: July 2006
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women ages 21-44 who are currently undergoing In Vitro Fertilization treatment at our center.

Criteria

Inclusion Criteria:

  • Women ages 21-44 undergoing IVF for infertility
  • Prior IVF cycle with poor response (≤4 follicles on ultrasound,≤ 4 oocytes retrieved, peak estradiol <1000 pg/mL, prior IVF cycle cancelled for poor response)

OR

  • Predicted poor response (age >40, basal FSH ≥10 mIU/mL, prior poor response to gonadotropin (peak estradiol <500 pg/mL))

Exclusion Criteria:

  • Medical contraindications for oral contraceptive pills, injectable gonadotropin medications, estradiol, or progesterone in oil use.
  • Medical contraindications to pregnancy
  • Prior IVF cycle with Microdose Protocol or Luteal Phase Ganirelix Protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00633555

Sponsors and Collaborators
University of Connecticut Health Center
Investigators
Principal Investigator: John Nulsen, MD The Center for Advanced Reproductive Services, P.C.
  More Information

No publications provided

Responsible Party: John Nulsen, MD, The Center for Advanced Reproductive Services
ClinicalTrials.gov Identifier: NCT00633555     History of Changes
Other Study ID Numbers: 06-198-2, CARS-06-198
Study First Received: March 4, 2008
Last Updated: February 9, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Ganirelix
Leuprolide
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
 Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on June 17, 2013