A Novel Approach to Endometrial Preparation in Recipients of Donor Eggs
1 other identifier
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 25, 2011
CompletedFirst Posted
Study publicly available on registry
August 29, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedAugust 29, 2011
August 1, 2011
6.7 years
August 25, 2011
August 25, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
endometrial thickness measured by ultrasound
In office ultrasound to measure thickness of endometrial lining.
2-4 weeks
Secondary Outcomes (1)
endometrial biopsy
3-6 weeks
Study Arms (2)
GnRh agonist
ACTIVE COMPARATORThis arm will use a GnRH agonist to suppress pituitary-ovarian function
GnRH antagonist
EXPERIMENTALA GnRH antagonist will be used to suppress pituitary-ovarian function
Interventions
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.
Ganirelix 250 mcg daily will be used to suppress pituitary-ovarian function and is administered concurrently with estradiol and progesterone for approximately two weeks.
Eligibility Criteria
You may qualify if:
- recipients awaiting egg donation
- some ovarian function
- normal endometrial cavity
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kelly, Maureen, M.D.lead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (1)
Society Hill Reproductive Medicine
Philadelphia, Pennsylvania, 19107, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maureen Kelly, MD
Society Hill Reproductive Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDIV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Director
Study Record Dates
First Submitted
August 25, 2011
First Posted
August 29, 2011
Study Start
January 1, 2006
Primary Completion
September 1, 2012
Last Updated
August 29, 2011
Record last verified: 2011-08