A Novel Approach to Endometrial Preparation in Recipients of Donor Eggs

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Brief Summary

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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.

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Detailed Description

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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. This protocol would generally take only two weeks to prepare the uterine lining.

Conditions

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Implantation, Embryo

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GnRh agonist

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

Group Type ACTIVE_COMPARATOR

Leuprolide

Intervention Type DRUG

leuprolide 10 units daily, decreased to 5 units daily once suppression achieved for a total of approximately 4 weeks. Once suppression achieved, estradiol and progesterone administered to mature uterine lining.

GnRH antagonist

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

Group Type EXPERIMENTAL

Ganirelix

Intervention Type DRUG

Ganirelix 250 mcg daily will be used to suppress pituitary-ovarian function and is administered concurrently with estradiol and progesterone for approximately two weeks.

Interventions

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Leuprolide

leuprolide 10 units daily, decreased to 5 units daily once suppression achieved for a total of approximately 4 weeks. Once suppression achieved, estradiol and progesterone administered to mature uterine lining.

Intervention Type DRUG

Ganirelix

Ganirelix 250 mcg daily will be used to suppress pituitary-ovarian function and is administered concurrently with estradiol and progesterone for approximately two weeks.

Intervention Type DRUG

Other Intervention Names

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Lupron Antagon

Eligibility Criteria

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Inclusion Criteria

* recipients awaiting egg donation
* some ovarian function
* normal endometrial cavity

Exclusion Criteria

* submucosal myoma
* myoma(s) greater than 4 centimeters
* endometrial polyp
* DES exposure
* documented recalcitrant thin endometrium ( \<7 mm)
* untreated vulvovaginitis
* active pelvic infection
* endometrial cancer or suspected/known hormonally sensitive cancers
* breast cancer
* thromboembolic disease
* cerebrovascular or coronary heart disease
* diabetes mellitus
* hepatic tumors or active liver disease
* severe hypertension
* headaches with neurologic disease
* cholestatic disease
* heavy smoking over age 35

Minimum Eligible Age

18 Years

Maximum Eligible Age

52 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes