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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00633555
Recruitment Status : Completed
First Posted : March 12, 2008
Last Update Posted : May 25, 2018
Information provided by (Responsible Party):
UConn Health

Brief Summary:
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 or disease

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 54 participants
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
Study Start Date : July 2006
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility
U.S. FDA Resources

Primary Outcome Measures :
  1. Implantation rate [ Time Frame: 4-6 weeks ]

Secondary Outcome Measures :
  1. Number of oocytes retrieved [ Time Frame: 4-6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 44 Years   (Adult)
Sexes 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.

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)


  • 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

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 identifier (NCT number): NCT00633555

Sponsors and Collaborators
UConn Health
Principal Investigator: John Nulsen, MD The Center for Advanced Reproductive Services, P.C.

Responsible Party: UConn Health Identifier: NCT00633555     History of Changes
Other Study ID Numbers: 06-198-2
First Posted: March 12, 2008    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists