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

• Status: Withdrawn
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: Female

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 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Treatments: Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Ganirelix; Hormone Antagonists; Hormones; Leuprolide; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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