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

NCT00826839 | Withdrawn Phase 4

• 1 other identifier: 0810010037
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Infertility

Keywords

In vitro fertilization; Poor responder patients; Randomized clinical trial; Estrogen patch; Gonadotropin-releasing hormone antagonist; Oral contraceptive pill; Microdose lupron

Outcome Measures

Primary Outcomes (1)

• Pregnancy rate

  7 weeks gestation

Secondary Outcomes (11)

• Cycle cancellation rate

  Cycle completion

• Peak estradiol level

  Cycle completion

• Ampules of gonadotropins required during ovarian stimulation

  Cycle completion

• Number of days of ovarian stimulation

  Cycle completion

• Number of oocytes retrieved

  Cycle completion

Study Arms (2)

OCP/MDL

EXPERIMENTAL

Oral contraceptive pills/microdose lupron

Drug: Oral contraceptive pill and microdose lupron

E2/antagonist

EXPERIMENTAL

Estradiol patch/gonadotropin-releasing hormone antagonist

Drug: E2 patch/antagonist

Interventions

Oral contraceptive pill and microdose lupron DRUG

Desogestrel/ethinyl estradiol tablets, 0.15 mg/0.03 mg, one tablet by mouth daily for 14 days Leuprolide acetate 40 µg by subcutaneous injection twice a day during ovarian stimulation (approximately 14 days)

Also known as: Ortho-Cept®, Desogen®, Reclipsen™, Apri®, Leuprorelin, Leuprorelin Acetate, Lupron

OCP/MDL

E2 patch/antagonist DRUG

Estradiol transdermal system 0.1 mg/day (25 cm2 patch. Patch changed every other day x 3. Final patch left on for about 7 days. Total duration of therapy approximately 14 days. Gonadotropin-releasing hormone antagonist 0.25 mg subcutaneously every other day for 3 total doses.

Also known as: Climara®, Ganirelix acetate injection®

E2/antagonist

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

The Ronald O. Perlman and Claudia Cohen Center for Reproductive Medicine at Weill Cornell Medical College

New York, New York, 10021, United States

Location

Related Links

• The Ronald O. Perlman and Claudia Cohen Center for Reproductive Medicine at Weill Cornell Medical College

MeSH Terms

Conditions

Infertility

Interventions

Contraceptives, Oral; Oviol; Desogestrel; Leuprolide; Estradiol; ganirelix

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Estrenes; Estranes; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Study Officials

• Zev Rosenwaks, M.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2009
• First Posted: January 22, 2009
• Study Start: January 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: January 1, 2012
• Last Updated: June 25, 2013

Record last verified: 2013-06

Locations

US (1)