Autologous Endometrial Coculture (AECCT)

Weill Cornell Medicine (WCM)

Status: Terminated

Conditions: Infertility

Treatments: Other: no endometrial biopsy or Autologous endometrial coculture (AECC) performed; Procedure: AECC (Autologous endometrial coculture)

Study type: Interventional

Funder types: Other

Identifiers

NCT01472861

0903010293

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups, including a placebo group

No AECC

Placebo Comparator group

Description:

Routine procedures without AECC

Treatment:

Other: no endometrial biopsy or Autologous endometrial coculture (AECC) performed

AECC

Experimental group

Description:

Endometrial biopsy and Autologous endometrial coculture

Treatment:

Procedure: AECC (Autologous endometrial coculture)