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Autologous Endometrial Coculture (AECCT)

This study is currently recruiting participants.
Verified December 2012 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: December 13, 2012
Last verified: December 2012
History of Changes
  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:

MedlinePlus related topics: Infertility
U.S. FDA Resources

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
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:
Ronald O. Perelman and Claudia Cohen Center for Reproductive Medicine  This link exits the ClinicalTrials.gov site

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: December 13, 2012
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
Adenoma
Genital Diseases, Male
Genital Diseases, Female
 Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 16, 2013