Autologous Endometrial Coculture (AECCT)

Infertility Clinical Trial

— AECCT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01472861
• Other study ID #: 0903010293
• Status: Terminated
• Phase: N/A
• First received: November 11, 2011
• Last updated: June 10, 2015
• Start date: October 2009
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: June 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Infertility

Intervention

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

Locations

Country	Name	City	State
United States	Center for Reproducutve Medicine; Weill Cornell Medical College	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy outcome		1 month	No
Secondary	Embryo quality		1 month	No

External Links

•   Ronald O. Perelman and Claudia Cohen Center for Reproductive Medicine