InfertilityNCT03191890
Post Market Surveillance & Post Market Clinical Follow up, International, Medical Registry to Confirm the Safety and the Performance of the Anecova Intra Uterine Culture Device
An observational study of Infertility and Reproductive Sterility, run by Anecova SA at 1 site in Spain.
Trial summary
This study is designed to generate a comprehensive survey of the use on the market of the Anecova device within its intended indications according to the Instructions For Use. The Anecova Registry is part of the Anecova quality system, to enable the Post Marketing Surveillance and the Post Market Clinical Follow-up. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Reproductive Sterility
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jun 2017to 31 Mar 2018
- How long will I take part?
- 9 Weeks
- Phase
- Observational
- 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 43 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Participants following a normal course of in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) can benefit from the use of the Anecova device
Who may be able to join
- Age between 18 and 43,
- Hormonal serum levels within normal ranges for the routinely or specifically tested hormones (FSH, LH, AMH, E2, PRL, P4, TSH),
- BMI between 18 and 29, If assessed normal antral follicular count and regular menses
Who cannot join
- Endometrial, autoimmune or hormonal specificities, as well as presence of pathology that could be potentially deleterious to the healthy development of embryos in the uterine cavity (i.e. severe endometriosis),
- Acute or chronic gynecological infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational, Non-Interventional, Prospective, Post Market Surveillance & Post Market Clinical Follow up, International, Medical Registry to Confirm the Safety and the Performance of the Anecova Intra Uterine Culture Device for Participants With Subfertility Issue Undergoing Assisted Reproductive Medical Treatment in Routine Clinical Practice
This study is designed to generate a comprehensive survey of the use on the market of the Anecova device within its intended indications according to the Instructions For Use. The Anecova Registry is part of the Anecova quality system, to enable the Post Marketing Surveillance and the Post Market Clinical Follow-up.
Read the detailed description
As soon as the very first minute of the fertilization process, very important biological events, critical for the future developmental competency of the embryo are taking place.
These biological events, after the sperm cell entry in the oocyte cytoplasm and prior to the first cleavage, include: the completion of the meiosis, the exclusion of the second polar body, the pronuclei formation, the replication of the male and female DNA and the chromosome segregation on the newly formed mitotic spindle.
If any of these events is aberrant, one or both of the two daughter cells and their descendants may carry chromosomal anomalies. In other words an uneven first cleavage in size or in content is associated with chromosomal abnormality and aneuploidy.
In vivo all these events occur in a natural environment where the presence of specific molecules and of a dynamic and physiological environment might be an advantage over in vitro culture conditions to ensure optimal cellular functions.
The Registry will capture information from the Anecova procedure, from the outcomes, from the procedure performance, from the safety and from the utilization of the Anecova Medical Device in clinical routine.
- Conditions
- Infertility, Reproductive Sterility
- Keywords
- in vivo culture
- Medical subject headings
- Infertility
What is being measured
The primary outcome is the main question the study is designed to answer.
Fertilization rate
Number of zygotes over all transferred injected/inseminated oocytes
Measured: 1 day
Secondary outcomes (3)
Biochemical Pregnancy rate
hCG test
Measured: 15 days
Implantation rate
number of gestational sac per transferred embryos
Measured: 5 weeks
Clinical pregnancy rate
beating heart
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start15 Jun 2017
- Primary completion31 Mar 2018
- Study completion31 Mar 2018
Why it stopped: Sponsor stopped the study due to poor enrollment
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 9 Weeks
Sponsor and investigators
- Lead sponsor
- Anecova SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03191890
- Sponsor's protocol ID
- NCV_REG_01
- Status last verified
- Apr 2019
- First submitted
- 16 Jun 2017
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational, Non-Interventional, Prospective, Post Market Surveillance & Post Market Clinical Follow up, International, Medical Registry to Confirm the Safety and the Performance of the Anecova Intra Uterine Culture Device for Participants With Subfertility Issue Undergoing Assisted Reproductive Medical Treatment in Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT03191890
- Acronym / sponsor ID
- NCV_REG_01
- Conditions
- Infertility, Reproductive Sterility
- Keywords
- in vivo culture
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Sponsor stopped the study due to poor enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Anecova SAIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 19 Jun 2017 (actual)
- 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.
This study is designed to generate a comprehensive survey of the use on the market of the Anecova device within its intended indications according to the Instructions For Use. The Anecova Registry is part of the Anecova quality system, to enable the Post Marketing Surveillance and the Post Market Clinical Follow-up.
Detailed description
As soon as the very first minute of the fertilization process, very important biological events, critical for the future developmental competency of the embryo are taking place.
These biological events, after the sperm cell entry in the oocyte cytoplasm and prior to the first cleavage, include: the completion of the meiosis, the exclusion of the second polar body, the pronuclei formation, the replication of the male and female DNA and the chromosome segregation on the newly formed mitotic spindle.
If any of these events is aberrant, one or both of the two daughter cells and their descendants may carry chromosomal anomalies. In other words an uneven first cleavage in size or in content is associated with chromosomal abnormality and aneuploidy.
In vivo all these events occur in a natural environment where the presence of specific molecules and of a dynamic and physiological environment might be an advantage over in vitro culture conditions to ensure optimal cellular functions.
The Registry will capture information from the Anecova procedure, from the outcomes, from the procedure performance, from the safety and from the utilization of the Anecova Medical Device in clinical routine.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 9 Weeks
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants following a normal course of in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) can benefit from the use of the Anecova device
Key inclusion criteria (3 listed)
- Age between 18 and 43,
- Hormonal serum levels within normal ranges for the routinely or specifically tested hormones (FSH, LH, AMH, E2, PRL, P4, TSH),
- BMI between 18 and 29, If assessed normal antral follicular count and regular menses
Key exclusion criteria (2 listed)
- Endometrial, autoimmune or hormonal specificities, as well as presence of pathology that could be potentially deleterious to the healthy development of embryos in the uterine cavity (i.e. severe endometriosis),
- Acute or chronic gynecological infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fertilization rate
Time frame: 1 day
Number of zygotes over all transferred injected/inseminated oocytes
3 secondary outcomes
Biochemical Pregnancy rate
Time frame: 15 days
Implantation rate
Time frame: 5 weeks
Clinical pregnancy rate
Time frame: 9 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility and Reproductive Sterility, run by Anecova SA at 1 site in Spain.
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 3 inclusion and 2 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: withdrawn, as of the sponsor's last update on 4 Apr 2019. 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 Spain. 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 was withdrawn before enrolling participants, so there are no results.
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?
Fertilization rate (time frame: 1 day). 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 4 Apr 2019.