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

Short name OMLET

NCTNCT00826839Other id0810010037

Open at ClinicalTrials.govAsk about this trial

This trial was withdrawn before it enrolled anyone.

Reason given at the registry: poor enrollment

Overview

Status: Withdrawn
Phase: Phase 4
Enrollment: 0 participants (actual)
Sponsor: Weill Medical College of Cornell University · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: Jan 2009
Primary completion: Sept 2010
Completion: Jan 2012
First posted: 22 Jan 2009 (estimated)
Last update posted: 25 Jun 2013 (estimated)
Conditions: Infertility

Timeline

1 trial · 1 stopped early

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20092010201120122013

Ph 4
OMLET
NCT00826839
Jan 2009 to Jan 2012
Withdrawn
Withdrawn

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Oral contraceptive pill and microdose lupronDrug
E2 patch/antagonistDrug

Arms2

Experimental
OCP/MDL
Oral contraceptive pills/microdose lupron
Experimental
E2/antagonist
Estradiol patch/gonadotropin-releasing hormone antagonist

Primary outcomes1

Outcomes the sponsor listed as primary.

Pregnancy rate
Time frame · 7 weeks gestation

Secondary outcomes(11)

Cycle cancellation rate
Time frame · Cycle completion
Peak estradiol level
Time frame · Cycle completion
Ampules of gonadotropins required during ovarian stimulation
Time frame · Cycle completion
Number of days of ovarian stimulation
Time frame · Cycle completion
Number of oocytes retrieved
Time frame · Cycle completion
Number of embryos transferred
Time frame · Cycle completion
Number of embryos frozen
Time frame · Cycle completion
Embryo grade
Time frame · Cycle completion
Implantation rate
Time frame · 7 weeks gestation
Miscarriage rate
Time frame · 20 weeks gestation
Pregnancy outcome
Time frame · Following delivery

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 50 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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