A Trial Evaluating Autologous Endometrial Co-Culture Versus Conventional Medium in the Treatment of Infertility

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Procedure: Endometrial biopsy; Other: Conventional media culture; Other: Autologous Endometrial Co-Culture

• Registration Number: NCT01886118
• Lead Sponsor: Clinique Ovo

Brief Summary

One of the main factors in the success of in-vitro fertilization is the quality of the environment of the embryo. In contrast to maternal age, the environment in which the embryo develops is a modifiable factor. Many techniques, such as assisted hatching and perfecting culture media have been attempted in order to reproduce as much as possible the natural, physiological environment of the mother for the embryo in in-vitro fertilization. However, the different new culture media used are devoid of growth factors normally secreted by uterine cells that enhance the interaction between the embryo and its environment.

Because the endometrial lining of the uterus secretes many different cytokines necessary for growth of the embryo, a new procedure has been developed to mimic the natural environment of the growing embryo using autologous (patient's own) endometrial cells in co-culture with the embryo. Endocell, a product developed by Genévrier Laboratories, received commercial authorization in France in 2011. It is the only system of autologous embryo-endometrium co-culture available on the actual market. The process consists of developing the embryo on a monolayer of the patient's own endometrial cells in order to favor its growth until the blastocyst stage (day 5) and to improve its implantation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-03
• Study Start: 2013-03
• Study First Submitted QC: 2013-06-21
• Study First Posted: 2013-06-25
• Primary Completion: 2015-09
• Study Completion: 2015-10
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-23
• Last Update Posted: 2015-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 207

Inclusion Criteria

• Undergoing In Vitro Fertilization (IVF) or IVF/Intra Cytoplasmic Sperm Injection (ICSI) at OVO clinic
• Having a prescription of a long, short or an antagonist IVF protocols using both urinary and synthetic gonadotropins
• Having a single embryo transfer
• Regular menstrual cycles
• Basal follicle stimulating hormone levels less than 10 IU/l within 6 months prior to entering the study
• anti-mullerian hormone more than 1 ng/ml measured within a year
• Normal sonohysterogram or hysteroscopy done within the last 2 years
• Previously undergone a maximum of 3 IVF cycles
• Documented negative serology tests within 1 year prior recruitment for: Hepatitis B, Syphilis, HIV based on Health Canada recommendations for treatment in an IVF laboratory.

Exclusion Criteria

• Amenorrhea
• Anovulatory cycles
• Polycystic Ovarian syndrome
• Chronic endometritis
• Severe endometriosis
• Hydrosalpinx
• Uterine synechia or Asherman's syndrome
• Submucosal uterine fibroids or intra-cavitary polyps greater than 1cm
• Uterine anomalies
• Use of anticoagulants
• Secretory Azoospermia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Autologous Endometrial Co-Culture	Endometrial biopsy	The embryos will be transferred to Endocell co-culture media for Autologous Endometrial Co-Culture between day 2 and day 5.
Conventional media culture	Conventional media culture	Patients in this arm will have their embryos cultured in conventional media
Autologous Endometrial Co-Culture	Autologous Endometrial Co-Culture	The embryos will be transferred to Endocell co-culture media for Autologous Endometrial Co-Culture between day 2 and day 5.
Conventional media culture	Endometrial biopsy	Patients in this arm will have their embryos cultured in conventional media

Primary Outcome Measures

Name	Time	Method
Pregnancy rates	7 weeks	Confirmed clinical pregnancy with positive fetal heart on the day of viability ultrasound

Secondary Outcome Measures

Name	Time	Method
Embryo quality	5 days	The number of cells and the grade of the embryos will be assess throughout their development.
Blastulation rate	5 days	Percentage of embryos that develops into blastocyst compared to the total number of embryos in culture
Cumulative pregnancy rate with frozen embryos	5 years	Pregnancy rate per patient including all transfer with frozen embryos

Trial Locations

Locations (1)

Clinique Ovo; 🇨🇦 Montreal, Quebec, Canada