Maximal Stimulation and Delayed Fertilization for Diminished Ovarian Reserve: a Randomized Pilot Study

What Was Tested

This registered phase 4 trial tested Leuprolide.

If ovarian stimulation is adequate, oocyte retrieval will be performed and viable oocytes vitrified (stored in a "glass-like" state in liquid nitrogen).

It had two arms (groups): clomiphene plus gonadotropins (active comparator) and Leuprolide flare (active comparator).

Clomiphene plus gonadotropins.

Leuprolide flare.

The registry classes the interventions as drug.

More on the Plan

All subjects must undergo pre-cycle IVF testing as per routine for the CMC ART program.

In general, the study will be comprised of subjects not eligible for IVF due to extremely poor prognosis because of expected compromised ovarian stimulation (see inclusion criteria below).

Subjects are financially responsible for all treatments in this study.

Randomized will be performed by a random number generator after informed consent has been signed.

Who Took Part

The registry lists 23 actual participants took part.

It was open to women only aged from 18 years with no upper age limit.

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

Examples of who could join: Basal FSH 15-17 (highest ever) and failed EFORT test. Age \> 43 at the time of expected retrieval. Failure to conceive with a prior "poor prognosis" IVF stimulation protocol (microdose leuprolide flare or GnRH antagonist cycle) if administered because of evidence of diminished ovarian reserve. Failure to conceive with 3 or more IVF cycles at CMC.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: contraindications to ivf; contraindication to pregnancy; allergy or contraindication to medications used for ivf or embryo transfer.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Leuprolide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Leuprolide study: the participants and staff both knew the treatment.

It started in 2011-01 with completion listed for 2011-11.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Oocytes (time frame: up to 24 months).

It also tracked 1 secondary outcome, for example Number of Oocytes Vitrified.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Leuprolide in 23 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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