Oral Microdose Lupron Versus Luteal Estradiol Trial in Poor Responder In Vitro Fertilization (IVF) Patients

Withdrawn before enrolling · Phase 4

Conditions studied: Infertility

In brief

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 fertilization (IVF). Usually, a woman produces at most one egg each month. Ovarian stimulation helps these women make more than one egg per month. However, this involves taking hormones that stimulate the ovary to produce many eggs at one time. The stimulatory hormones injected with a small needle. The eggs are removed from the ovary through a surgical procedure and then placed in a dish for fertilization by sperm to form embryos. The embryos are grown in the laboratory then replaced into the woman's uterus 3-5 days later. The stimulation of the ovaries is important. Some patients undergo ovarian stimulation for IVF but do not respond to the treatment. This is a very difficult situation because even though several ovarian stimulation protocols have been used for poor responder patients, it is not clear which protocol works best. In fact, two of the most commonly used protocols have not been directly compared. This study will randomize (like flipping a coin) couples with a history of low response who are going to start IVF treatment into two groups. In one group the female partner will use a protocol called "E2 patch/antagonist". These women will use an estrogen patch and injected antagonist for several days before starting injectable fertility medications. The other group will use a protocol called "OCP/microdose". This group of women will use oral contraceptive pills (OCPs) and small doses of lupron along with the other injectable fertility medications. We will then follow their progress to see how many eggs they produce and how many women get pregnant.

Key facts

Study ID: NCT00826839
Run by: Weill Medical College of Cornell University
People needed: 0
Starts: 2009-01-01
Expected to finish: 2012-01-01
Last updated by the study team: 2013-06-25

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

The Ronald O. Perlman and Claudia Cohen Center for Reproductive Medicine at Weill Cornell Medical College — New York, New York, United States

Full record on ClinicalTrials.gov

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