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

What Was Tested

The trial (phase 4) is built around Leuprolide.

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.

It had two arms (groups): OCP/MDL (experimental) and E2/antagonist (experimental).

Oral contraceptive pills/microdose lupron.

Estradiol patch/gonadotropin-releasing hormone antagonist.

The registry classes the interventions as drug.

More on the Plan

These patients often undergo initial treatment with insemination using oral or injectable medications.

However, if this fails to achieve a pregnancy, patients often undergo in vitro fertilization (IVF).

IVF is a process which involves a protocol of injectable medications to stimulate the ovary to produce several eggs at once.

These eggs are retrieved under ultrasound guidance and fertilized in the laboratory.

Who Took Part

It was open to women only aged from 18 years up to 50 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 7 inclusion and 11 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Leuprolide and who got the comparison, which limits bias.

The Leuprolide group and the comparison group ran side by side rather than switching.

Being open-label, the Leuprolide study did not mask who received what.

It started in 2009-01 with completion listed for 2010-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Pregnancy rate (time frame: 7 weeks gestation).

It also tracked 11 secondary outcomes, for example Cycle cancellation rate, Peak estradiol level, Ampules of gonadotropins required during ovarian stimulation, Number of days of ovarian stimulation, Number of oocytes retrieved and Number of embryos transferred.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Leuprolide in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Leuprolide compound page, all human trials.