A Novel Approach to Endometrial Preparation in Recipients of Donor Eggs
Recruitment status was: Recruiting
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 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|
- endometrial thickness measured by ultrasound [ Time Frame: 2-4 weeks ] [ Designated as safety issue: No ]In office ultrasound to measure thickness of endometrial lining.
- 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.
|Study Start Date:||January 2006|
|Estimated Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
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 Name: 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 Name: Antagon
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01424618
|United States, Pennsylvania|
|Society Hill Reproductive Medicine|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Maureen Kelly, MD||Society Hill Reproductive Medicine|