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Autologous Endometrial Coculture (AECCT) (AECCT)

Primary Purpose

Infertility

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AECC (Autologous endometrial coculture)
no endometrial biopsy or Autologous endometrial coculture (AECC) performed
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring coculture, endometrial biopsy, IVF poor responders

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Center for Reproducutve Medicine; Weill Cornell Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

No AECC

AECC

Arm Description

Routine procedures without AECC

Endometrial biopsy and Autologous endometrial coculture

Outcomes

Primary Outcome Measures

Pregnancy outcome

Secondary Outcome Measures

Embryo quality

Full Information

First Posted
November 11, 2011
Last Updated
June 10, 2015
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT01472861
Brief Title
Autologous Endometrial Coculture (AECCT)
Acronym
AECCT
Official Title
A Randomized Controlled Trial Evaluating Autologous Endometrial Coculture (AECC) As An Effective Tool For Young Patients With Poor Ovarian Reserve
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Why Stopped
poor recruitment
Study Start Date
October 2009 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
coculture, endometrial biopsy, IVF poor responders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No AECC
Arm Type
Placebo Comparator
Arm Description
Routine procedures without AECC
Arm Title
AECC
Arm Type
Experimental
Arm Description
Endometrial biopsy and Autologous endometrial coculture
Intervention Type
Procedure
Intervention Name(s)
AECC (Autologous endometrial coculture)
Intervention Description
endometrial biopsy with autologous endometrial coculture
Intervention Type
Other
Intervention Name(s)
no endometrial biopsy or Autologous endometrial coculture (AECC) performed
Intervention Description
routine procedures with out biopsy
Primary Outcome Measure Information:
Title
Pregnancy outcome
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Embryo quality
Time Frame
1 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Spandorfer Steven, MD
Organizational Affiliation
Weill Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Reproducutve Medicine; Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Links:
URL
http://ivf.org
Description
Ronald O. Perelman and Claudia Cohen Center for Reproductive Medicine

Learn more about this trial

Autologous Endometrial Coculture (AECCT)

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