Recruiting

Endometrial Preparation

Sponsor:

Kelly, Maureen, M.D.

Code:

NCT01424618

Conditions

Implantation, Embryo

Eligibility Criteria

Sex: Female

Age: 18 - 52

Healthy Volunteers: Accepted

Interventions

Leuprolide

Ganirelix

Study Details

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.

Conditions

Implantation, Embryo

Study ID

NCT01424618

Start date

Jan, 2006

Status verified date

Aug, 2011

Primary completion date

Sep, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 52

Healthy Volunteers: Accepted

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 Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: GnRh agonist

This arm will use a GnRH agonist to suppress pituitary-ovarian function

experimental: GnRH antagonist

A GnRH antagonist will be used to suppress pituitary-ovarian function

Interventions

Leuprolide

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

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

Primary outcome measure

  • endometrial thickness measured by ultrasound [ Time Frame: 2-4 weeks ]

Central Contacts and Locations

Central contacts

Dana Tillotson, BSN

215-829-8110dtillotson@reproductivemedicinepa.com

Locations

Society Hill Reproductive Medicine

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Dana Tillotson, BSN

215-829-8110dtillotson@reproductivemedicinepa.com

Principal Investigator:

Maureen Kelly, MD

More Information

Sponsor

Kelly, Maureen, M.D.

Last update posted

Aug 29, 2011

Last verified

Aug, 2011

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Kelly, Maureen, M.D. on 2011-08-29.