in Vitro FertilizationAMIFIVNCT03785119
Improvement of in Vitro Fertilization Implantation by Soluble CD146 Dose in Embryonic Culture Environment
An observational study of in Vitro Fertilization, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The study of implantation potential of the embryo stay a priority in In Vitro Fertilization (IVF). Indeed, the selection of embryos to transfer is actually based in routine check on morphologic criteria, approved by literature but not perfect. Read more about this study
- Who is it for?
- Ages 18 to 42 yearsHealthy volunteers can take part
- Conditions the study is for
- in Vitro Fertilization
- How many people
- 318 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2019to Jan 2023
- 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 42 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Couples benefiting of at least one of the two embryos and a transfer of one frozen embryo (FET)
Who may be able to join
- FET realization in the selected population
- IVF try with a third-party
- IVF try without embryo freezing
- Freezing only one embryo
- Non separately freezing of embryos (2/vial)
- Female patients <18 years and >42 years
- Male patients <18 years
Who cannot join
- Refusal to participate at the study of at least one member of the couple
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Biologie de la Reproduction
Marseille, 13005
Odile Lacroix-Paulmyer, PUPH, 04 91 38 13 78, odile.lacroix-paulmyer@ap-hm.fr
About this study
Official title: Improvement of in Vitro Fertilization Implantation by Soluble CD146 Dose in Embryonic Culture Environment : Multicenter Prospective Study
The study of implantation potential of the embryo stay a priority in In Vitro Fertilization (IVF). Indeed, the selection of embryos to transfer is actually based in routine check on morphologic criteria, approved by literature but not perfect. Implantation's markers identification, allowing to choose the embryo(s) to transfer and then decrease pregnancy failure, represent a major issue in IVF, not any biomarker being approved yet.
Among factors regulating embryonic implantation, investigators have recently proposed soluble CD146, coming from proteolytic cleavage of the CD146 membrane, angiogenic bond molecule.
Read more
In a monocentric study about 222 transferred embryos at the end of IVF try, investigators showed that the sCD146 dose in the embryonic culture environment reflected the implantation ability of embryo, a high rate showing a low implantation potential and this independently of the embryonic quality. A multicentric prospective study is now required to confirm the utility of this dosage in clinical practice.
Primary objective : Compared 2 frozen embryo transfer (FET) strategies in terms of implantation efficiency, according to choice method of embryo to be transferred :
- Group A : Standard strategy : Depending on embryonic quality according to criteria currently selected.
- Group B : Experimental strategy : Association of embryonic quality according to criteria currently selected and of sCD146 rate.
Expected Results :
- Demonstrate a beginning pregnancy test significantly superior in Group B compared to Group A.
- Confirmed that sCD146 is an independent biomarker of morphologic embryonic quality (actual selection criteria) and represent a complementary criteria to choose embryos to transfer.
Methodology :
- Multicentric prospective study with 2 groups of Frozen Embryo Transfer (FET); The calculation of the number of staff required includes 151 couples per group.
For this will be include for 24 months, couples benefiting of freezing at least one of the two embryos and transfer of only one FET.
- Test the same day of environment freezing where frozen embryos were cultivated. sCD146 dosage by ELISA technic (Enzyme Linked ImmunoSorbent Assay) in thus culture environment before FET.
- Implantation potential analyze of each transfer embryo (FET) according to sCD146 rate.
- Following of the FET future(pregnancy, childbirth) : maximum 9 months after attempt to each included couple.
- Conditions
- in Vitro Fertilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Standard strategy | According to embryo quality (morphologic criteria) | |
| Experimental strategy | Association of embryo quality and sCD146 rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beginner pregnancy rate at 1st transfer (%)
Corresponds to number of defined pregnancy by plasmatic quantity of hCG (human chorionic gonadotropin) >100 UI/l 15 days after FET/number of FET.
Measured: 0 to 9 months after FET
Secondary outcomes (1)
Beginner pregnancy rate at 2nd or 3rd transfer
Corresponds to number of defined pregnancy by plasmatic quantity of hCG >100 UI/l 15 days after FET/number of FET.
Measured: 0 to 9 months after FET
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study startJan 2019 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for in Vitro FertilizationStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- 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
- 318 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Olivier Arnaud, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03785119
- Sponsor's protocol ID
- 2018-20
- Acronym
- AMIFIV
- Status last verified
- Dec 2018
- First submitted
- 17 Dec 2018
- Last updated
- 24 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of in Vitro Fertilization Implantation by Soluble CD146 Dose in Embryonic Culture Environment : Multicenter Prospective Study
- ClinicalTrials.gov ID
- NCT03785119
- Acronym / sponsor ID
- AMIFIV / 2018-20
- Conditions
- in Vitro Fertilization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 318 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Jan 2019 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 24 Dec 2018 (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.
The study of implantation potential of the embryo stay a priority in In Vitro Fertilization (IVF). Indeed, the selection of embryos to transfer is actually based in routine check on morphologic criteria, approved by literature but not perfect. Implantation's markers identification, allowing to choose the embryo(s) to transfer and then decrease pregnancy failure, represent a major issue in IVF, not any biomarker being approved yet.
Among factors regulating embryonic implantation, investigators have recently proposed soluble CD146, coming from proteolytic cleavage of the CD146 membrane, angiogenic bond molecule.
In a monocentric study about 222 transferred embryos at the end of IVF try, investigators showed that the sCD146 dose in the embryonic culture environment reflected the implantation ability of embryo, a high rate showing a low implantation potential and this independently of the embryonic quality. A multicentric prospective study is now required to confirm the utility of this dosage in clinical practice.
Primary objective : Compared 2 frozen embryo transfer (FET) strategies in terms of implantation efficiency, according to choice method of embryo to be transferred :
- Group A : Standard strategy : Depending on embryonic quality according to criteria currently selected.
- Group B : Experimental strategy : Association of embryonic quality according to criteria currently selected and of sCD146 rate.
Expected Results :
- Demonstrate a beginning pregnancy test significantly superior in Group B compared to Group A.
- Confirmed that sCD146 is an independent biomarker of morphologic embryonic quality (actual selection criteria) and represent a complementary criteria to choose embryos to transfer.
Methodology :
- Multicentric prospective study with 2 groups of Frozen Embryo Transfer (FET); The calculation of the number of staff required includes 151 couples per group.
For this will be include for 24 months, couples benefiting of freezing at least one of the two embryos and transfer of only one FET.
- Test the same day of environment freezing where frozen embryos were cultivated. sCD146 dosage by ELISA technic (Enzyme Linked ImmunoSorbent Assay) in thus culture environment before FET.
- Implantation potential analyze of each transfer embryo (FET) according to sCD146 rate.
- Following of the FET future(pregnancy, childbirth) : maximum 9 months after attempt to each included couple.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard strategy | – | –According to embryo quality (morphologic criteria) |
| Experimental strategy | – | –Association of embryo quality and sCD146 rate |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Couples benefiting of at least one of the two embryos and a transfer of one frozen embryo (FET)
Key inclusion criteria (7 listed)
- FET realization in the selected population
- IVF try with a third-party
- IVF try without embryo freezing
- Freezing only one embryo
- Non separately freezing of embryos (2/vial)
Key exclusion criteria (1 listed)
- Refusal to participate at the study of at least one member of the couple
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
Beginner pregnancy rate at 1st transfer (%)
Time frame: 0 to 9 months after FET
Corresponds to number of defined pregnancy by plasmatic quantity of hCG (human chorionic gonadotropin) >100 UI/l 15 days after FET/number of FET.
1 secondary outcome
Beginner pregnancy rate at 2nd or 3rd transfer
Time frame: 0 to 9 months after FET
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2018.
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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.
Jean Olivier Arnaud study director
Assistance Publique Hôpitaux de Marseille
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 in Vitro Fertilization, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 7 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Dec 2018. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Odile Lacroix-Paulmyer, PUPH (+33 (0)4 91 38 13 78, odile.lacroix-paulmyer@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beginner pregnancy rate at 1st transfer (%) (time frame: 0 to 9 months after FET). 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 2018.