Autologous Endometrial Coculture (AECCT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Weill Medical College of Cornell University
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01472861
First received: November 11, 2011
Last updated: September 5, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Infertility
Procedure: AECC (Autologous endometrial coculture)
Other: no endometrial biopsy or Autologous endometrial coculture (AECC) performed

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Evaluating Autologous Endometrial Coculture (AECC) As An Effective Tool For Young Patients With Poor Ovarian Reserve

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Pregnancy outcome [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Embryo quality [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 224
Study Start Date: October 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: No AECC
Routine procedures without AECC
Other: no endometrial biopsy or Autologous endometrial coculture (AECC) performed
routine procedures with out biopsy
Experimental: AECC
Endometrial biopsy and Autologous endometrial coculture
Procedure: AECC (Autologous endometrial coculture)
endometrial biopsy with autologous endometrial coculture

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01472861

Locations
United States, New York
Center for Reproducutve Medicine; Weill Cornell Medical College Recruiting
New York, New York, United States, 10021
Contact: Rodriq Stubbs, NP    646-962-3276    res2011@med.cornell.edu   
Contact: Mitasha Joseph, RN    646-962-3382    mij2008@med.cormell.edu   
Principal Investigator: Steven Spandorfer, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Spandorfer Steven, MD Weill Medical College
  More Information

Additional Information:
No publications provided

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01472861     History of Changes
Other Study ID Numbers: 0903010293
Study First Received: November 11, 2011
Last Updated: September 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
coculture
endometrial biopsy
IVF poor responders

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 26, 2014