Status:
WITHDRAWN
Oral Microdose Lupron Versus Luteal Estradiol Trial in Poor Responder In Vitro Fertilization (IVF) Patients
Lead Sponsor:
Weill Medical College of Cornell University
Conditions:
Infertility
Eligibility:
FEMALE
18-50 years
Phase:
PHASE4
Brief Summary
Hundreds of thousands of couples in the United States experience infertility each year. When initial measures do not help, some couples require a process called ovarian stimulation and in vitro fertil...
Detailed Description
Patients who have difficulty conceiving naturally often seek medical advice. These patients often undergo initial treatment with insemination using oral or injectable medications. However, if this fai...
Eligibility Criteria
Inclusion
- Females of couples with an indication for IVF who have a history of poor response as defined by one of the following:
- Cancellation of IVF due to inadequate follicular development
- Peak estradiol \< 1000 pg/mL
- \< 6 oocytes retrieved
- Age ≥18 years at the time of signing informed consent
- Availability of ejaculatory sperm (use of donated and/or cryopreserved sperm is allowed)
- Willing and able to sign informed consent
Exclusion
- Prior use of the E2/ganirelix or OCP/microdose protocol
- Less than 2 ovaries or any other ovarian abnormality
- Presence of uncorrected unilateral or bilateral hydrosalpinx
- Presence of any clinically relevant pathology affecting the uterine cavity or intramural fibroid ≥ 5cm
- Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, clinically significant ovarian cysts)
- Contraindications for the use of oral contraceptive pills (h/o thromboembolism, breast cancer, undiagnosed vaginal bleeding)
- Contraindications for the use of estrogen patches (h/o thromboembolism, breast cancer, undiagnosed vaginal bleeding)
- Abnormal karyotyping of the patient or her partner (if karyotyping is performed)
- Hypersensitivity to any of the concomitant medication prescribed as part of the treatment regimen in this protocol
- Transfer of embryos to the patient not planned (i.e. gestational carrier use planned, embryos to be frozen)
- Unable to give informed consent
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00826839
Start Date
January 1 2009
End Date
January 1 2012
Last Update
June 25 2013
Active Locations (1)
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1
The Ronald O. Perlman and Claudia Cohen Center for Reproductive Medicine at Weill Cornell Medical College
New York, New York, United States, 10021