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A Novel Approach to Endometrial Preparation in Recipients of Donor Cycles


N/A
18 Years
52 Years
Open (Enrolling)
Female
Implantation, Embryo

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Trial Information

A Novel Approach to Endometrial Preparation in Recipients of Donor Cycles


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

endometrial thickness measured by ultrasound

Outcome Description:

In office ultrasound to measure thickness of endometrial lining.

Outcome Time Frame:

2-4 weeks

Safety Issue:

No

Principal Investigator

Maureen Kelly, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Society Hill Reproductive Medicine

Authority:

United States: Institutional Review Board

Study ID:

39604

NCT ID:

NCT01424618

Start Date:

January 2006

Completion Date:

Related Keywords:

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

Name

Location

Society Hill Reproductive MedicinePhiladelphia, Pennsylvania  19107