Autologous Endometrial Coculture (AECCT) (AECCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01472861
Recruitment Status : Terminated (poor recruitment)
First Posted : November 17, 2011
Last Update Posted : June 12, 2015
Information provided by (Responsible Party):
Weill Medical College of Cornell University

November 11, 2011
November 17, 2011
June 12, 2015
October 2009
June 2014   (Final data collection date for primary outcome measure)
Pregnancy outcome [ Time Frame: 1 month ]
Same as current
Complete list of historical versions of study NCT01472861 on Archive Site
Embryo quality [ Time Frame: 1 month ]
Same as current
Not Provided
Not Provided
Autologous Endometrial Coculture (AECCT)
A Randomized Controlled Trial Evaluating Autologous Endometrial Coculture (AECC) As An Effective Tool For Young Patients With Poor Ovarian Reserve
The purpose of this study is to determine if the use of Autologous Endometrial Coculture (AECC) in young in vitro fertilization (IVF) patients with poor ovarian reserve improves pregnancy outcome.
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.
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Procedure: AECC (Autologous endometrial coculture)
    endometrial biopsy with autologous endometrial coculture
  • Other: no endometrial biopsy or Autologous endometrial coculture (AECC) performed
    routine procedures with out biopsy
  • Placebo Comparator: No AECC
    Routine procedures without AECC
    Intervention: Other: no endometrial biopsy or Autologous endometrial coculture (AECC) performed
  • Experimental: AECC
    Endometrial biopsy and Autologous endometrial coculture
    Intervention: Procedure: AECC (Autologous endometrial coculture)
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2015
June 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 38 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Weill Medical College of Cornell University
Weill Medical College of Cornell University
Not Provided
Principal Investigator: Spandorfer Steven, MD Weill Medical College
Weill Medical College of Cornell University
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP