Skip to content

A Novel Approach to Endometrial Preparation in Recipients of Donor Eggs

A Novel Approach to Endometrial Preparation in Recipients of Donor Cycles

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01424618
Enrollment
20
Registered
2011-08-29
Start date
2006-01-31
Completion date
Unknown
Last updated
2011-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Implantation, Embryo

Keywords

Donor eggs, Donor oocytes, Pregnancy, Embryo Implantation, Infertility, IVF

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.

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.

Interventions

DRUGLeuprolide

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.

DRUGGanirelix

Ganirelix 250 mcg daily will be used to suppress pituitary-ovarian function and is administered concurrently with estradiol and progesterone for approximately two weeks.

Sponsors

Merck Sharp & Dohme LLC
CollaboratorINDUSTRY
Kelly, Maureen, M.D.
Lead SponsorINDIV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 52 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
endometrial thickness measured by ultrasound2-4 weeksIn office ultrasound to measure thickness of endometrial lining.

Secondary

MeasureTime frameDescription
endometrial biopsy3-6 weeksIn office aspiration of endometrial cells will be examined microscopically to determine if they are at an appropriate stage for implantation.

Countries

United States

Contacts

Primary ContactDana Tillotson, BSN
dtillotson@reproductivemedicinepa.com215-829-8110

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026