A Trial Evaluating Autologous Endometrial Co-Culture Versus Conventional Medium in the Treatment of Infertility (OvoGEN)
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|ClinicalTrials.gov Identifier: NCT01886118|
Recruitment Status : Completed
First Posted : June 25, 2013
Last Update Posted : December 24, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Procedure: Endometrial biopsy Other: Autologous Endometrial Co-Culture Other: Conventional media culture||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||207 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||A Randomized Trial Evaluating Autologous Endometrial Co-Culture Versus Conventional Medium in the Treatment of Infertility|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||October 2015|
Experimental: 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.
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 cycleOther: Autologous Endometrial Co-Culture
embryos will be transferred to Endocell co-culture media for Autologous Endometrial Co-Culture between day 2 and day 5
Active Comparator: Conventional media culture
Patients in this arm will have their embryos cultured in conventional media
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 cycleOther: Conventional media culture
embryos are cultured in conventional media
- Pregnancy rates [ Time Frame: 7 weeks ]Confirmed clinical pregnancy with positive fetal heart on the day of viability ultrasound
- Embryo quality [ Time Frame: 5 days ]The number of cells and the grade of the embryos will be assess throughout their development.
- Blastulation rate [ Time Frame: 5 days ]Percentage of embryos that develops into blastocyst compared to the total number of embryos in culture
- Cumulative pregnancy rate with frozen embryos [ Time Frame: 5 years ]Pregnancy rate per patient including all transfer with frozen embryos
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01886118
|Montreal, Quebec, Canada, H4P 2S4|
|Principal Investigator:||Jacques Kadoch, MD||OVO R & D|