A Novel Approach to Endometrial Preparation in Recipients of Donor Eggs

Not Applicable

• Conditions: Implantation, Embryo
• Interventions: Drug: Leuprolide; Drug: Ganirelix

• Registration Number: NCT01424618
• Lead Sponsor: Kelly, Maureen, M.D.

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2006-01
• Status Verified: 2011-08
• Study First Submitted: 2011-08-25
• Study First Submitted QC: 2011-08-25
• Last Update Submitted: 2011-08-25
• Study First Posted: 2011-08-29
• Last Update Posted: 2011-08-29
• Primary Completion: 2012-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GnRh agonist	Leuprolide	This arm will use a GnRH agonist to suppress pituitary-ovarian function
GnRH antagonist	Ganirelix	A GnRH antagonist will be used to suppress pituitary-ovarian function

Primary Outcome Measures

Name	Time	Method
endometrial thickness measured by ultrasound	2-4 weeks	In office ultrasound to measure thickness of endometrial lining.

Secondary Outcome Measures

Name	Time	Method
endometrial biopsy	3-6 weeks	In office aspiration of endometrial cells will be examined microscopically to determine if they are at an appropriate stage for implantation.

Trial Locations

Locations (1)

Society Hill Reproductive Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States