Autologous Endometrial Coculture (AECCT)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infertility

Intervention / Treatment
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* Procedure: AECC (Autologous endometrial coculture)
* Other: no endometrial biopsy or Autologous endometrial coculture (AECC) performed


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: No AECC<br>Routine procedures without AECC | Other: no endometrial biopsy or Autologous endometrial coculture (AECC) performed<br>* routine procedures with out biopsy<br>|
| Experimental: AECC<br>Endometrial biopsy and Autologous endometrial coculture | Procedure: AECC (Autologous endometrial coculture)<br>* endometrial biopsy with autologous endometrial coculture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy outcome |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Embryo quality |  | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coculture, endometrial biopsy, IVF poor responders