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A Novel Approach to Endometrial Preparation in Recipients of Donor Eggs

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2011 by Kelly, Maureen, M.D..
Recruitment status was:  Recruiting
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Maureen Kelly, M.D., Kelly, Maureen, M.D. Identifier:
First received: August 25, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted

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.

Condition Intervention
Implantation, Embryo
Drug: Leuprolide
Drug: Ganirelix

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Novel Approach to Endometrial Preparation in Recipients of Donor Cycles

Resource links provided by NLM:

Further study details as provided by Kelly, Maureen, M.D.:

Primary Outcome Measures:
  • endometrial thickness measured by ultrasound [ Time Frame: 2-4 weeks ]
    In office ultrasound to measure thickness of endometrial lining.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 20
Study Start Date: January 2006
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: GnRh agonist
This arm will use a GnRH agonist to suppress pituitary-ovarian function
Drug: 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.
Other Name: Lupron
Experimental: GnRH antagonist
A GnRH antagonist will be used to suppress pituitary-ovarian function
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.
Other Name: Antagon

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.


Ages Eligible for Study:   18 Years to 52 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01424618

Contact: Dana Tillotson, BSN 215-829-8110

United States, Pennsylvania
Society Hill Reproductive Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Dana Tillotson, BSN    215-829-8110   
Principal Investigator: Maureen Kelly, MD         
Sponsors and Collaborators
Kelly, Maureen, M.D.
Merck Sharp & Dohme Corp.
Principal Investigator: Maureen Kelly, MD Society Hill Reproductive Medicine
  More Information

Responsible Party: Maureen Kelly, M.D., Medical Director, Kelly, Maureen, M.D. Identifier: NCT01424618     History of Changes
Other Study ID Numbers: 39604
Study First Received: August 25, 2011
Last Updated: August 25, 2011

Keywords provided by Kelly, Maureen, M.D.:
Donor eggs
Donor oocytes
Embryo Implantation

Additional relevant MeSH terms:
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents processed this record on May 24, 2017