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A Randomized Controlled Trial Evaluating Autologous Endometrial Coculture (AECC) As An Effective Tool For Young Patients With Poor Ovarian Reserve


N/A
18 Years
38 Years
Open (Enrolling)
Female
Infertility

Thank you

Trial Information

A Randomized Controlled Trial Evaluating Autologous Endometrial Coculture (AECC) As An Effective Tool For Young Patients With Poor Ovarian Reserve


Young women with poor ovarian reserve are commonly given a poor prognosis for IVF success.
Standard culture media for fertilizing oocytes (unfertilized eggs) is commonly used in IVF
which closely resembles tubal fluid. Efforts to create optimal culture conditions for
fertilization of human embryos for women with poor quality embryos and/or repeated
implantation failures have been developed at our center by using AECC. AECC involves placing
a patient's fertilized eggs on top of a layer of cells from her own uterine lining, creating
a more natural environment for embryo development and maximizing the chance for IVF
pregnancy. The investigators will prospectively randomize young patients (≤ age 38 years)
poor ovarian reserve to AECC or no AECC with standard culture media to study pregnancy
outcome.


Inclusion Criteria:



- Healthy women undergoing IVF at CRMI

- Age ≤ 38 years

- Poor ovarian reserve with antral follicle count less than 6 follicles, cycle day 2/3
FSH > 12 ng/ml, AMH < 0.5 ng/ml

Exclusion Criteria:

- Healthy women undergoing IVF with male factor, severe endometriosis, or tubal factor
infertility

- Donor patients

- Contraindications for the use of gonadotropins (i.e. pregnancy, lactation,
undiagnosed vaginal bleeding or ovarian cysts)

- Recent or current medical conditions where the patient is not medically stable to
undergo stimulation or egg retrieval, HIV infection, diabetes, cardiovascular
disease, gastrointestinal, hepatic disease, renal or pulmonary disease.

- Any patient who is not a candidate for IVF

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Pregnancy outcome

Outcome Time Frame:

1 month

Safety Issue:

No

Principal Investigator

Spandorfer Steven, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Weill Medical College

Authority:

United States: Institutional Review Board

Study ID:

0903010293

NCT ID:

NCT01472861

Start Date:

October 2009

Completion Date:

December 2014

Related Keywords:

  • Infertility
  • coculture
  • endometrial biopsy
  • IVF poor responders
  • Infertility
  • Adenoma

Name

Location
Center for Reproducutve Medicine; Weill Cornell Medical College New York, New York  10021