- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01424618
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dana Tillotson, BSN
- Phone Number: 215-829-8110
- Email: dtillotson@reproductivemedicinepa.com
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Recruiting
- Society Hill Reproductive Medicine
-
Contact:
- Dana Tillotson, BSN
- Phone Number: 215-829-8110
- Email: dtillotson@reproductivemedicinepa.com
-
Principal Investigator:
- Maureen Kelly, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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 Names:
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
endometrial thickness measured by ultrasound
Time Frame: 2-4 weeks
|
In office ultrasound to measure thickness of endometrial lining.
|
2-4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3-6 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Maureen Kelly, MD, Society Hill Reproductive Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 39604
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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