We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 Maureen Kelly, M.D., Kelly, Maureen, M.D..
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01424618
First Posted: August 29, 2011
Last Update Posted: August 29, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Maureen Kelly, M.D., Kelly, Maureen, M.D.
August 25, 2011
August 29, 2011
August 29, 2011
January 2006
September 2012   (Final data collection date for primary outcome measure)
endometrial thickness measured by ultrasound [ Time Frame: 2-4 weeks ]
In office ultrasound to measure thickness of endometrial lining.
Same as current
No Changes Posted
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.
Same as current
Not Provided
Not Provided
 
A Novel Approach to Endometrial Preparation in Recipients of Donor Eggs
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Implantation, Embryo
  • 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
  • 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
  • Active Comparator: GnRh agonist
    This arm will use a GnRH agonist to suppress pituitary-ovarian function
    Intervention: Drug: Leuprolide
  • Experimental: GnRH antagonist
    A GnRH antagonist will be used to suppress pituitary-ovarian function
    Intervention: Drug: Ganirelix
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
20
Not Provided
September 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 52 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01424618
39604
Yes
Not Provided
Not Provided
Maureen Kelly, M.D., Kelly, Maureen, M.D.
Kelly, Maureen, M.D.
Merck Sharp & Dohme Corp.
Principal Investigator: Maureen Kelly, MD Society Hill Reproductive Medicine
Kelly, Maureen, M.D.
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP