Status:
COMPLETED
Luteal Phase FSH in the IVF Poor Responder
Lead Sponsor:
University of Pennsylvania
Conditions:
Infertility
Eligibility:
FEMALE
20-42 years
Phase:
PHASE4
Brief Summary
In vitro fertilization (IVF) is a common procedure used to assist couples who have difficulty conceiving a pregnancy. IVF is a process where oocytes (eggs) are retrieved from a woman's ovaries and fer...
Eligibility Criteria
Inclusion
- Infertile women planning to undergo IVF
- Poor ovarian response in most-recent previous IVF cycle within the past 18 months as defined by the following criteria:
- A) \<5 dominant follicles day of hCG, B) \<5 oocytes retrieved, or C) cancellation of a previous IVF cycle due to poor response to ovulation stimulation.
- Aged 20-42 (inclusive) at the time of randomization
- Presence of both ovaries
- Normal pap smear within past three years
- At least 45 days after the last IVF cycle
- Be willing and able to comply with the protocol for the duration of the study
- Have given written informed consent, prior to any study-related procedure, not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
Exclusion
- Clinically significant systemic disease
- Current regular cigarette smoking by patient report
- Known to be positive for Human Immunodeficiency Virus
- Any medical condition which, in the judgment of the investigator and sponsor, may interfere with the absorption, distribution, metabolism or excretion of the medications used
- Abnormal, undiagnosed gynecological bleeding
- Known allergy or hypersensitivity to human gonadotropin preparations
- Simultaneous participation in another investigational drug or device trial
- Subject fails, in 2 separate menstrual cycle attempts, to have FSH ≤12.0 and an ultrasound exam within normal limits (per standard for IVF) at the Baseline Visit
- For subjects randomized to the Luteal Phase Regimen, failure to ovulate in 2 separate menstrual cycle attempts, as evidenced by ovulation predictor kit, progesterone level, and /or visualization of corpus luteum cyst on an ovary by ultrasound exam at the Luteal Visit
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00225433
Start Date
September 1 2005
End Date
June 1 2008
Last Update
December 3 2015
Active Locations (1)
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1
University of Pennsylvania Reproductive Research Unit
Philadelphia, Pennsylvania, United States, 19104