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A Novel Approach to Endometrial Preparation in Recipients of Donor Eggs

This study is currently recruiting participants.
Verified August 2011 by Kelly, Maureen, M.D.
Sponsor:
Collaborator:
Merck
Information provided by (Responsible Party):
Maureen Kelly, M.D., Kelly, Maureen, M.D.
ClinicalTrials.gov Identifier:
NCT01424618
First received: August 25, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
  Purpose

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
Endpoint Classification: Bio-equivalence Study
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:

MedlinePlus related topics: Infertility
U.S. FDA Resources

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

Primary Outcome Measures:
  • endometrial thickness measured by ultrasound [ Time Frame: 2-4 weeks ] [ Designated as safety issue: No ]
    In office ultrasound to measure thickness of endometrial lining.


Secondary Outcome Measures:
  • endometrial biopsy [ Time Frame: 3-6 weeks ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years to 52 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01424618

Contacts
Contact: Dana Tillotson, BSN 215-829-8110 dtillotson@reproductivemedicinepa.com

Locations
United States, Pennsylvania
Society Hill Reproductive Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Dana Tillotson, BSN     215-829-8110     dtillotson@reproductivemedicinepa.com    
Principal Investigator: Maureen Kelly, MD            
Sponsors and Collaborators
Kelly, Maureen, M.D.
Merck
Investigators
Principal Investigator: Maureen Kelly, MD Society Hill Reproductive Medicine
  More Information

No publications provided

Responsible Party: Maureen Kelly, M.D., Medical Director, Kelly, Maureen, M.D.
ClinicalTrials.gov Identifier: NCT01424618     History of Changes
Other Study ID Numbers: 39604
Study First Received: August 25, 2011
Last Updated: August 25, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Ganirelix
Leuprolide
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
 Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on May 23, 2013