A Novel Approach to Endometrial Preparation in Recipients of Donor Eggs

August 25, 2011 updated by: Maureen Kelly, M.D., Kelly, Maureen, M.D.

A Novel Approach to Endometrial Preparation in Recipients of Donor Cycles

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.

Study Overview

Status

Unknown

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Society Hill Reproductive Medicine
        • Contact:
        • Principal Investigator:
          • Maureen Kelly, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 52 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: GnRh agonist
This arm will use a GnRH agonist to suppress pituitary-ovarian function
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.
Other Names:
  • Lupron
Experimental: GnRH antagonist
A GnRH antagonist will be used to suppress pituitary-ovarian function
Ganirelix 250 mcg daily will be used to suppress pituitary-ovarian function and is administered concurrently with estradiol and progesterone for approximately two weeks.
Other Names:
  • Antagon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
endometrial thickness measured by ultrasound
Time Frame: 2-4 weeks
In office ultrasound to measure thickness of endometrial lining.
2-4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Maureen Kelly, MD, Society Hill Reproductive Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Anticipated)

September 1, 2012

Study Registration Dates

First Submitted

August 25, 2011

First Submitted That Met QC Criteria

August 25, 2011

First Posted (Estimate)

August 29, 2011

Study Record Updates

Last Update Posted (Estimate)

August 29, 2011

Last Update Submitted That Met QC Criteria

August 25, 2011

Last Verified

August 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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