A Novel Approach to Endometrial Preparation in Recipients of Donor Eggs

What Was Tested

This registered not phased trial tested Leuprolide for endometriosis.

This study compares two different methods to prepare the uterine lining of recipients for implantation in cycles using donor eggs.

The study method requires less time than the standard method.

It is hypothesized that both methods would be suitable for use in egg donor cycles.

It had two arms (groups): GnRh agonist (active comparator) and GnRH antagonist (experimental).

This arm will use a GnRH agonist to suppress pituitary-ovarian function.

A GnRH antagonist will be used to suppress pituitary-ovarian function.

The registry classes the interventions as drug.

More on the Plan

Currently a combination of medications is used to prepare the uterine lining of recipients for implantation in egg donor cycles.

The protocol used most commonly is as follows: Initially the individual's own pituitary-ovarian system is suppressed using a GnRH agonist so there are not conflicting signals sent to the uterus.

This is followed by hormonal medication identical to what is secreted by the ovaries to prepare the uterine lining for subsequent embryo transfer in donor egg cycles.This preparation typically takes a minimum of four weeks.

This study will compare a different medication, a GnRh antagonist (which is commonly used in IVF) to suppress an individual's system during the preparation of the uterine lining.

Who Took Part

The registry lists 20 planned participants were the target.

It was open to women only aged from 18 years up to 52 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Recipients awaiting egg donation. Some ovarian function. Normal endometrial cavity.

The full record lists 3 inclusion and 17 exclusion criteria; among the exclusions: submucosal myoma; myoma(s) greater than 4 centimeters; endometrial polyp.

How the Study Was Run

Design: 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.

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

Everyone knew when Leuprolide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2006-01 with completion listed for 2012-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: endometrial thickness measured by ultrasound (time frame: 2-4 weeks).

It also tracked 1 secondary outcome, for example endometrial biopsy.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Leuprolide in 20 people with endometriosis.

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Leuprolide compound page, Endometriosis research.