We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT00633555
First Posted: March 12, 2008
Last Update Posted: February 10, 2011
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.
Information provided by:
UConn Health
  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:


Further study details as provided by UConn Health:

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

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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.
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
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): NCT00633555


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

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
First Submitted: March 4, 2008
First Posted: March 12, 2008
Last Update Posted: February 10, 2011
Last Verified: February 2011

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Leuprolide
Ganirelix
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