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

NCT00633555 | Completed

• 2 other identifiers: 06-198-2CARS-06-198
• Study Type: observational
• Target: 54
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• Implantation rate

  4-6 weeks

Secondary Outcomes (1)

• Number of oocytes retrieved

  4-6 weeks

Eligibility Criteria

• Age: 21 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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))

You may not qualify if:

• 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

Sponsors & Collaborators

• UConn Health: lead

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• John Nulsen, MD

  The Center for Advanced Reproductive Services, P.C.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2008
• First Posted: March 12, 2008
• Study Start: July 1, 2006
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: May 25, 2018

Record last verified: 2018-05