InfertilityPREVENIR-FIVNCT06100523
PREVenting-ENvIronment-Reprotoxic Exposures Before In Vitro Fertilization (PREVENIR-FIV)
A study testing Visioconsulation, self-assessment questionnaire and hair sampling in people with Infertility, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The objective is to evaluate the effectiveness of an innovative personalized management strategy adapted to the level of environmental risk, in a population of infertile couples, eligible for assisted reproductive treatment (ART) by intraconjugal In Vitro Fertilization (IVF)/ Intracytoplasmic sperm injection (ICSI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infertility
- What is being tested?
- Visioconsulation, self-assessment questionnaire and hair sampling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,224 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2024to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Couple eligible for a first attempt of conventional In Vitro Fertilization (IVF) or Intra Cytoplasmic Sperm Injection (IVF-ICSI) intra-marital;
- Signature of informed consent by both partners of the couple;
- Possession of a smartphone.
Who cannot join
- Not fluent in the language;
- Refusal to participate in the study of one or both members of the couple;
- Use of cryopreserved intra-conjugal gametes before management in MPA;
- Use of gamete donation, embryo reception;
- History of chemotherapy/radiotherapy;
- Support in viral risk circuit;
- Not having a smartphone.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Assitance Publique Hôpitaux de Marseille
Marseille, 13005
Jeanne PERRIN, 06 10 48 93 23, jeanne.perrin@univ-amu.fr
About this study
Official title: Multidisciplinary Platform Designed to Reduce and Prevent Environmental Reprotoxic Exposures in Subfertile Couples: Assessment of the Contribution of Such Platforms on the Birth Rate After In Vitro Fertilization: Randomized Open Prospective Comparative Multicentric Study
The objective is to evaluate the effectiveness of an innovative personalized management strategy adapted to the level of environmental risk, in a population of infertile couples, eligible for assisted reproductive treatment (ART) by intraconjugal In Vitro Fertilization (IVF)/ Intracytoplasmic sperm injection (ICSI).
Consultation of the couple at the ARTcenter : - Prescriptions of the standard assessment of infertility to the couples eligible for ART. - Inclusion and randomization (arm A interventional vs arm B standard management) of the couples having signed the consent. - Information for each patient on a standardized online self questionnaire on environmental exposures, physical activity and stress.
Read the detailed description
- Arm A (interventional): analysis of the responses to the self-administered questionnaires with, if necessary, protocol interview concerning environmental and occupational factors, which will determine the consultations to be planned for their follow-up by the platform. - support of couples by the multidisciplinary platform with the help of the downloaded application: Meeting by videoconsultation with professionals adapted to the exposures highlighted by the questionnaires. Multidisciplinary Synthesis (MS): Synthesis of the first consultations and the results of the self-questionnaires by the multidisciplinary team. Determination of preventive and corrective measures, specific advice, specialized follow-up if necessary. Presentation to patients of the personalized measures decided in MS: information on the personalized management proposed (follow-up addictologist, dietician, psychologist, occupational doctor), personalized advice sheets. Couples who do not require personalized measures will continue their treatment with prevention advice adapted to their profession and their environment. Transmission of the minutes of the MS to the clinician in charge of the couple.
- Arm B (standard management): care path according to the usual modalities of the ART center (indications, network of practitioners, monitoring and information tools). If necessary, distribution by the clinician of information leaflets on addictions, dietetics + distribution of a general information leaflet on reprotoxic factors.
In both arms: embryology consultation before ART: information on the planned ART. Information on the online self-assessment questionnaire for assessing reprotoxic exposures, assessing stress, physical activity, and quality of life during infertility. In centers with a biological resource center Germethèque, hair sampling from the 2 members of the couple.
First attempt of IVF/ICSI, in both arms, followed for 24 months with every 6 months: information of the online self-administered questionnaire of assessment of reprotoxic exposures, assessment of stress, physical activity, quality of life in infertility course. At 12 months and 24 months: hair sampling from both members of the couple (in Germethèque centers only).
- In arm A during the 24 months of follow-up: active support of corrective measures implemented with couples by the platform, with the help of the application (weight loss goals, changes in habits, physical activity, decreased or stopped toxics). Continuation of specialized follow-up if necessary, in videoconsultation.
At the end of the study: a sample of about twenty couples in each arm will be the subject of a semi-directed interview aimed at qualitatively determining the brakes and levers to their adherence to the environmental health advice received during their management in ART.
Medical-economic analysis: a cost-effectiveness analysis and a budget impact analysis will be carried out by the Epidemiology and Health Economics Department.
- Conditions
- Infertility
- Being tested
- Visioconsulation, self-assessment questionnaire, hair sampling, self-assessment questionnaire on dedicated application, Specialized follow-up
- Keywords
- Infertility, In Vitro Fertilization, Intracytoplasmic Sperm Injection
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VisioconsulationBehavioural
Meeting by videoconsultation with professionals adapted to the exposures highlighted by the questionnaires for patients who responded on the dedicated application (Arm A)
self-assessment questionnaireBehavioural
self-administered questionnaire of assessment of reprotoxic exposures, assessment of stress, physical activity, quality of life in infertility course
hair samplingBiological
hair sampling from the 2 members of the couple
self-assessment questionnaire on dedicated applicationBehavioural
self-administered questionnaire of assessment of reprotoxic exposures, assessment of stress, physical activity, quality of life in infertility course
Specialized follow-upBehavioural
proactive healthcare pathway : active support of corrective measures implemented with couples by the platform, with the help of the application
self-assessment questionnaire for follow-upBehavioural
self-administered questionnaire of assessment of reprotoxic exposures, assessment of stress, physical activity, quality of life in infertility course
| Study group | Role | What they receive |
|---|---|---|
| Arm A (interventional) | Experimental | Analysis of the responses to the self-administered questionnaires with, if necessary, protocol interview concerning environmental and occupational factors, which will determine the consultations to be planned for their follow-up by the platform Receives: Behavioral: Visioconsulation; Biological: hair sampling; Behavioral: self-assessment questionnaire on dedicated application; Behavioral: Specialized follow-up; Behavioral: self-assessment questionnaire for follow-up |
| Arm B (standard management) | Active comparator | Care path according to the usual modalities of the assisted reproductive treatment (ART) center Receives: Behavioral: self-assessment questionnaire; Biological: hair sampling; Behavioral: self-assessment questionnaire for follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical live birth rate
Proportion of couples who obtained at least one live birth during the 24 months of assisted reproductive treatment (ART) treatment (birth(s) obtained after In Vitro Fertilization (IVF)/Intracytoplasmic Sperm Injectionc (ICSI), frozen embryo transfer (FET) from IVF/ICSI, or spontaneous pregnancy obtained between ART treatments), in Arm A versus arm B.
Measured: 24 months
Secondary outcomes (7)
Clinical pregnancy rate
Proportion of couples who achieved at least one clinical pregnancy (presence of gestational sac with cardiac activity at 8 SA) during the 24 months of ART management (pregnancies obtained after IVF/ICSI, frozen embryo transfers (FET) or spontaneously), comparison in both arms.
Measured: 24 months
Embryology markers
In IVF/ICSI performed in both arms, comparison of fertilization rates, rate of useful embryos (transferred or cryopreserved), embryo implantation rate
Measured: 24 months
Pregnancy markers
On clinical pregnancies obtained after ART or spontaneously during the 24 months of ART management, comparison in both arms: rates of progressive pregnancies (presence of cardiac activity at 12 weeks of amenorrheae)
Measured: 24 months
Pregnancy markers
On clinical pregnancies obtained after ART or spontaneously during the 24 months of ART management, comparison in both arms: rates of obstetric pathology (at least one of the following complications = high blood pressure, gestational diabetes, cholestasis, placenta previa, placental abruption, intrauterine growth retardation, missing twin syndrome, premature rupture of membranes, threat of premature delivery, 3rd trimester hemorrhage, preterm birth, postpartum hemorrhage)
Measured: 24 months
Newborn health
term,
Measured: at birth
Behavior changes
evaluation of behavior changes like : consumption of toxic substances, physical activity, eating habits, stress management, protection against environmental/occupational reprotoxins and the quality of life of couples in both arms during follow-up
Measured: 24 months
qualitative analysis
Qualitative analysis of the brakes and levers related to the adherence of couples to the measures of prevention and correction of reprotoxic exposures proposed during their management in ART (in both arms)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study startJan 2024 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François CREMIEUX, Study director, Assistance Publique - Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06100523
- Sponsor's protocol ID
- RCAPHM21_0387
- Other IDs
- 2022-A01017-36
- Acronym
- PREVENIR-FIV
- Status last verified
- Sep 2023
- First submitted
- 21 Sep 2023
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sunyach C, Courbiere B, Simon N, Delva F, Garlantezec R, Bretelle F, Leandri R, Gehanno JF, Esquirol Y, Loubiere S, Resseguier N, Sari-Minodier I, Perrin J. PREVENIR-IVF: study protocol for a prospective multicentre randomized open comparative trial, which explores the efficacy of a multidisciplinary platform reducing and preventing reprotoxic environmental exposures in subfertile couples on live birth rate after assisted reproduction treatment. Trials. 2025 Dec 22;26(1):575. doi: 10.1186/s13063-025-09208-8.
PubMed 41430276
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Platform Designed to Reduce and Prevent Environmental Reprotoxic Exposures in Subfertile Couples: Assessment of the Contribution of Such Platforms on the Birth Rate After In Vitro Fertilization: Randomized Open Prospective Comparative Multicentric Study
- ClinicalTrials.gov ID
- NCT06100523
- Acronym / sponsor ID
- PREVENIR-FIV / RCAPHM21_0387
- Conditions
- Infertility
- Keywords
- Infertility, In Vitro Fertilization, Intracytoplasmic Sperm Injection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,224 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 25 Oct 2023 (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 objective is to evaluate the effectiveness of an innovative personalized management strategy adapted to the level of environmental risk, in a population of infertile couples, eligible for assisted reproductive treatment (ART) by intraconjugal In Vitro Fertilization (IVF)/ Intracytoplasmic sperm injection (ICSI).
Consultation of the couple at the ARTcenter : - Prescriptions of the standard assessment of infertility to the couples eligible for ART. - Inclusion and randomization (arm A interventional vs arm B standard management) of the couples having signed the consent. - Information for each patient on a standardized online self questionnaire on environmental exposures, physical activity and stress.
Detailed description
- Arm A (interventional): analysis of the responses to the self-administered questionnaires with, if necessary, protocol interview concerning environmental and occupational factors, which will determine the consultations to be planned for their follow-up by the platform. - support of couples by the multidisciplinary platform with the help of the downloaded application: Meeting by videoconsultation with professionals adapted to the exposures highlighted by the questionnaires. Multidisciplinary Synthesis (MS): Synthesis of the first consultations and the results of the self-questionnaires by the multidisciplinary team. Determination of preventive and corrective measures, specific advice, specialized follow-up if necessary. Presentation to patients of the personalized measures decided in MS: information on the personalized management proposed (follow-up addictologist, dietician, psychologist, occupational doctor), personalized advice sheets. Couples who do not require personalized measures will continue their treatment with prevention advice adapted to their profession and their environment. Transmission of the minutes of the MS to the clinician in charge of the couple.
- Arm B (standard management): care path according to the usual modalities of the ART center (indications, network of practitioners, monitoring and information tools). If necessary, distribution by the clinician of information leaflets on addictions, dietetics + distribution of a general information leaflet on reprotoxic factors.
In both arms: embryology consultation before ART: information on the planned ART. Information on the online self-assessment questionnaire for assessing reprotoxic exposures, assessing stress, physical activity, and quality of life during infertility. In centers with a biological resource center Germethèque, hair sampling from the 2 members of the couple.
First attempt of IVF/ICSI, in both arms, followed for 24 months with every 6 months: information of the online self-administered questionnaire of assessment of reprotoxic exposures, assessment of stress, physical activity, quality of life in infertility course. At 12 months and 24 months: hair sampling from both members of the couple (in Germethèque centers only).
- In arm A during the 24 months of follow-up: active support of corrective measures implemented with couples by the platform, with the help of the application (weight loss goals, changes in habits, physical activity, decreased or stopped toxics). Continuation of specialized follow-up if necessary, in videoconsultation.
At the end of the study: a sample of about twenty couples in each arm will be the subject of a semi-directed interview aimed at qualitatively determining the brakes and levers to their adherence to the environmental health advice received during their management in ART.
Medical-economic analysis: a cost-effectiveness analysis and a budget impact analysis will be carried out by the Epidemiology and Health Economics Department.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (interventional) | Experimental | Behavioral: Visioconsulation, Biological: hair sampling, Behavioral: self-assessment questionnaire on dedicated application, Behavioral: Specialized follow-up, Behavioral: self-assessment questionnaire for follow-upAnalysis of the responses to the self-administered questionnaires with, if necessary, protocol interview concerning environmental and occupational factors, which will determine the consultations to be planned for their follow-up by the platform |
| Arm B (standard management) | Active comparator | Behavioral: self-assessment questionnaire, Biological: hair sampling, Behavioral: self-assessment questionnaire for follow-upCare path according to the usual modalities of the assisted reproductive treatment (ART) center |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Couple eligible for a first attempt of conventional In Vitro Fertilization (IVF) or Intra Cytoplasmic Sperm Injection (IVF-ICSI) intra-marital;
- Signature of informed consent by both partners of the couple;
- Possession of a smartphone.
Key exclusion criteria (7 listed)
- Not fluent in the language;
- Refusal to participate in the study of one or both members of the couple;
- Use of cryopreserved intra-conjugal gametes before management in MPA;
- Use of gamete donation, embryo reception;
- History of chemotherapy/radiotherapy;
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 |
|---|---|---|
| VisioconsulationMeeting by videoconsultation with professionals adapted to the exposures highlighted by the questionnaires for patients who responded on the dedicated application (Arm A) | Behavioural | Arm A (interventional) |
| self-assessment questionnaireself-administered questionnaire of assessment of reprotoxic exposures, assessment of stress, physical activity, quality of life in infertility course | Behavioural | Arm B (standard management) |
| hair samplinghair sampling from the 2 members of the couple | Biological | Arm A (interventional), Arm B (standard management) |
| self-assessment questionnaire on dedicated applicationself-administered questionnaire of assessment of reprotoxic exposures, assessment of stress, physical activity, quality of life in infertility course | Behavioural | Arm A (interventional) |
| Specialized follow-upproactive healthcare pathway : active support of corrective measures implemented with couples by the platform, with the help of the application | Behavioural | Arm A (interventional) |
| self-assessment questionnaire for follow-upself-administered questionnaire of assessment of reprotoxic exposures, assessment of stress, physical activity, quality of life in infertility course | Behavioural | Arm A (interventional), Arm B (standard management) |
Primary outcome
Clinical live birth rate
Time frame: 24 months
Proportion of couples who obtained at least one live birth during the 24 months of assisted reproductive treatment (ART) treatment (birth(s) obtained after In Vitro Fertilization (IVF)/Intracytoplasmic Sperm Injectionc (ICSI), frozen embryo transfer (FET) from IVF/ICSI, or spontaneous pregnancy obtained between ART treatments), in Arm A versus arm B.
7 secondary outcomes
Clinical pregnancy rate
Time frame: 24 months
Embryology markers
Time frame: 24 months
Pregnancy markers
Time frame: 24 months
Pregnancy markers
Time frame: 24 months
Newborn health
Time frame: at birth
Behavior changes
Time frame: 24 months
qualitative analysis
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Derived from this study: PubMed 41430276Sunyach C, Courbiere B, Simon N, Delva F, Garlantezec R, Bretelle F, Leandri R, Gehanno JF, Esquirol Y, Loubiere S, Resseguier N, Sari-Minodier I, Perrin J. PREVENIR-IVF: study protocol for a prospective multicentre randomized open comparative trial, which explores the efficacy of a multidisciplinary platform reducing and preventing reprotoxic environmental exposures in subfertile couples on live birth rate after assisted reproduction treatment. Trials. 2025 Dec 22;26(1):575. doi: 10.1186/s13063-025-09208-8.
- 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.
François CREMIEUX 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?
A study testing Visioconsulation, self-assessment questionnaire and hair sampling in people with Infertility, 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 3 inclusion and 7 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: opening soon, as of the sponsor's last update on 25 Oct 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeanne PERRIN (06 10 48 93 23, jeanne.perrin@univ-amu.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical live birth rate (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06100523, which also lists 1 linked publication.
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 25 Oct 2023.