InfertilityOvoGENNCT01886118
A Trial Evaluating Autologous Endometrial Co-Culture Versus Conventional Medium in the Treatment of Infertility
A study testing Endometrial biopsy, Autologous Endometrial Co-Culture and Conventional media culture in people with Infertility, run by Clinique Ovo at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Endometrial biopsy, Autologous Endometrial Co-Culture and Conventional media culture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2013to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- Amenorrhea
- Anovulatory cycles
- Polycystic Ovarian syndrome
- Chronic endometritis
- Severe endometriosis
- Hydrosalpinx
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- Uterine synechia or Asherman's syndrome
- Submucosal uterine fibroids or intra-cavitary polyps greater than 1cm
- Uterine anomalies
- Use of anticoagulants
- Secretory Azoospermia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial Evaluating Autologous Endometrial Co-Culture Versus Conventional Medium in the Treatment of Infertility
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.
- Conditions
- Infertility
- Being tested
- Endometrial biopsy, Autologous Endometrial Co-Culture, Conventional media culture
- Keywords
- In vitro fertilization, Autologous Endometrial Co-Culture
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endometrial biopsyProcedure or surgery
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
Autologous Endometrial Co-CultureOther
embryos will be transferred to Endocell co-culture media for Autologous Endometrial Co-Culture between day 2 and day 5
Conventional media cultureOther
embryos are cultured in conventional media
| Study group | Role | What they receive |
|---|---|---|
| Autologous Endometrial Co-Culture | Experimental | The embryos will be transferred to Endocell co-culture media for Autologous Endometrial Co-Culture between day 2 and day 5. Receives: Procedure: Endometrial biopsy; Other: Autologous Endometrial Co-Culture |
| Conventional media culture | Active comparator | Patients in this arm will have their embryos cultured in conventional media Receives: Procedure: Endometrial biopsy; Other: Conventional media culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rates
Confirmed clinical pregnancy with positive fetal heart on the day of viability ultrasound
Measured: 7 weeks
Secondary outcomes (3)
Embryo quality
The number of cells and the grade of the embryos will be assess throughout their development.
Measured: 5 days
Blastulation rate
Percentage of embryos that develops into blastocyst compared to the total number of embryos in culture
Measured: 5 days
Cumulative pregnancy rate with frozen embryos
Pregnancy rate per patient including all transfer with frozen embryos
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study startMar 2013
- Primary completionSep 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Ovo
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Genevrier Laboratories
- Responsible party
- Sponsor
- Investigators
- Jacques Kadoch, MD, Principal investigator, Clinique Ovo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886118
- Sponsor's protocol ID
- OVO-12-24
- Acronym
- OvoGEN
- Status last verified
- Dec 2015
- First submitted
- 3 Jan 2013
- Last updated
- 24 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Evaluating Autologous Endometrial Co-Culture Versus Conventional Medium in the Treatment of Infertility
- ClinicalTrials.gov ID
- NCT01886118
- Acronym / sponsor ID
- OvoGEN / OVO-12-24
- Conditions
- Infertility
- Keywords
- In vitro fertilization, Autologous Endometrial Co-Culture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Clinique OvoIndustry (pharma, biotech, devices)
- Collaborators
- Genevrier Laboratories
- Study start
- Mar 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 25 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous Endometrial Co-Culture | Experimental | Procedure: Endometrial biopsy, Other: Autologous Endometrial Co-CultureThe embryos will be transferred to Endocell co-culture media for Autologous Endometrial Co-Culture between day 2 and day 5. |
| Conventional media culture | Active comparator | Procedure: Endometrial biopsy, Other: Conventional media culturePatients in this arm will have their embryos cultured in conventional media |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- Amenorrhea
- Anovulatory cycles
- Polycystic Ovarian syndrome
- Chronic endometritis
- Severe endometriosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endometrial biopsyA 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 | Procedure or surgery | Autologous Endometrial Co-Culture, Conventional media culture |
| Autologous Endometrial Co-Cultureembryos will be transferred to Endocell co-culture media for Autologous Endometrial Co-Culture between day 2 and day 5 | Other | Autologous Endometrial Co-Culture |
| Conventional media cultureembryos are cultured in conventional media | Other | Conventional media culture |
Primary outcome
Pregnancy rates
Time frame: 7 weeks
Confirmed clinical pregnancy with positive fetal heart on the day of viability ultrasound
3 secondary outcomes
Embryo quality
Time frame: 5 days
Blastulation rate
Time frame: 5 days
Cumulative pregnancy rate with frozen embryos
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques Kadoch, MD principal investigator
Clinique Ovo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endometrial biopsy, Autologous Endometrial Co-Culture and Conventional media culture in people with Infertility, run by Clinique Ovo at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy rates (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2015.