Infertility Clinical Trial
— OvoGENOfficial title:
A Randomized Trial Evaluating Autologous Endometrial Co-Culture Versus Conventional Medium in the Treatment of Infertility
Verified date | December 2015 |
Source | OVO R & D |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Clinique Ovo | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
OVO R & D | Genevrier Laboratories |
Canada,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03607409 -
Role of Inhibin A as Biomarker for Ovarian Response for IVF Treatment
|
||
Recruiting |
NCT02312076 -
GnRHa for Luteal Phase Support in Long GnRHa Protocol Cycles
|
Phase 4 | |
Terminated |
NCT02161861 -
Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study
|
N/A | |
Completed |
NCT03287479 -
Comparison of a Semi-automated Closed Vitrification System (Gavi®) With a Manual Open Vitrification Sytem (Cryotop®)
|
N/A | |
Terminated |
NCT03522350 -
Randomized Trial Comparing EmbryoScope With EmbryoScope+.
|
N/A | |
Completed |
NCT04496284 -
Embryo Transfer Outcomes After Vitrification With Slush Nitrogen Compared to Liquid Nitrogen
|
N/A | |
Completed |
NCT03623659 -
pArtiaL zonA pelluciDa Removal by assisteD hatchINg of Blastocysts
|
N/A | |
Completed |
NCT03895099 -
New Ovarian Stimulation With Random Start, Use of Progestin Protocol for Oocyte Donors
|
Phase 3 | |
Active, not recruiting |
NCT04142112 -
Randomized, Standard-Controlled, Study to Evaluate the Ohana IVF Sperm Preparation Kit, SPeRtility IVF Next Generation
|
N/A | |
Completed |
NCT03152643 -
Cumulative Live Birth Rates After Cleavage-stage Versus Blastocyst-stage Embryo Transfer
|
N/A | |
Recruiting |
NCT03683771 -
Assessment of Endometrial Pattern and Sub-endometrial Vascularity in ICSI Outcome
|
||
Recruiting |
NCT03161119 -
Comparing Two Different Embryo Transfer Catheters
|
N/A | |
Completed |
NCT04108039 -
Micronized Progesterone vs Gonadotropin-releasing Hormone (GnRH) Antagonist in Freeze-all IVF Cycles.
|
N/A | |
Completed |
NCT03677492 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Cytochalasin D ( ICSI-CD)
|
N/A | |
Completed |
NCT03678610 -
Handling Medium for ICSI With Ionomycin and Latrunculin A
|
N/A | |
Completed |
NCT03678597 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin B ( ICSI-LB)
|
N/A | |
Completed |
NCT03678584 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Chaetoglobosin A ( ICSI-CA)
|
N/A | |
Completed |
NCT03678818 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin A (ICSI-LA)
|
N/A | |
Completed |
NCT03678558 -
Oocyte Vitrification Aided With Cytochalasin B
|
N/A | |
Completed |
NCT03678571 -
Oocyte Vitrification Aided With Latrunculin A
|
N/A |