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

Infertility Clinical Trial

— OvoGEN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01886118
• Other study ID #: OVO-12-24
• Status: Completed
• Phase: N/A
• First received: January 3, 2013
• Last updated: December 23, 2015
• Start date: March 2013
• Est. completion date: October 2015

Study information

• Verified date: December 2015
• Source: OVO R & D
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Procedure:
• Endometrial biopsy
A luteal phase endometrial biopsy will be performed in the cycle prior to the patient's In Vitro Fertilization stimulation cycle using a standard Pipelle Endometrial Suction curette in all participants between days ovulation+5 and ovulation+7 of the cycle preceding the stimulation cycle

Other:
• Autologous Endometrial Co-Culture
embryos will be transferred to Endocell co-culture media for Autologous Endometrial Co-Culture between day 2 and day 5
• Conventional media culture
embryos are cultured in conventional media

Locations

Country	Name	City	State
Canada	Clinique Ovo	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
OVO R & D	Genevrier Laboratories

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy rates	Confirmed clinical pregnancy with positive fetal heart on the day of viability ultrasound	7 weeks	No
Secondary	Embryo quality	The number of cells and the grade of the embryos will be assess throughout their development.	5 days	No
Secondary	Blastulation rate	Percentage of embryos that develops into blastocyst compared to the total number of embryos in culture	5 days	No
Secondary	Cumulative pregnancy rate with frozen embryos	Pregnancy rate per patient including all transfer with frozen embryos	5 years	No