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

Tracking Information

First Received Date ^ICMJE

November 11, 2011

Last Updated Date

December 13, 2012

Start Date ^ICMJE

October 2009

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Pregnancy outcome [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01472861 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Embryo quality [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Autologous Endometrial Coculture (AECCT)

Official Title ^ICMJE

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

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Infertility

Intervention ^ICMJE

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

Study Arm (s)

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)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

224

Estimated Completion Date

December 2014

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 38 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01472861

Other Study ID Numbers ^ICMJE

0903010293

Has Data Monitoring Committee

Responsible Party

Weill Medical College of Cornell University

Study Sponsor ^ICMJE

Weill Medical College of Cornell University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Spandorfer Steven, MD

Weill Medical College

Information Provided By

Weill Medical College of Cornell University

Verification Date

December 2012

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

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