A Novel Approach to Endometrial Preparation in Recipients of Donor Eggs

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Novel Approach to Endometrial Preparation in Recipients of Donor Cycles

Conditions
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Implantation, Embryo

Intervention / Treatment
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* Drug: Leuprolide
* Drug: Ganirelix


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 52 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVF, Donor eggs, Donor oocytes, Pregnancy, Embryo Implantation, Infertility