Assitance Publique Hôpitaux de Marseille
Marseille, 13005, France
NCT Number: NCT06100523
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Marseille, 13005, France
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).
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Meeting by videoconsultation with professionals adapted to the exposures highlighted by the questionnaires for patients who responded on the dedicated application (Arm A)
self-administered questionnaire of assessment of reprotoxic exposures, assessment of stress, physical activity, quality of life in infertility course
hair sampling from the 2 members of the couple
self-administered questionnaire of assessment of reprotoxic exposures, assessment of stress, physical activity, quality of life in infertility course
proactive healthcare pathway : active support of corrective measures implemented with couples by the platform, with the help of the application
self-administered questionnaire of assessment of reprotoxic exposures, assessment of stress, physical activity, quality of life in infertility course
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.
Time frame: 24 months
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.
Time frame: 24 months
In IVF/ICSI performed in both arms, comparison of fertilization rates, rate of useful embryos (transferred or cryopreserved), embryo implantation rate
Time frame: 24 months
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)
Time frame: 24 months
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)
Time frame: at birth
term,
Time frame: 24 months
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
Time frame: 24 months
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)
Contact information is provided by the study sponsor or research team.
Claire MORANDO
CONTACT
Jeanne PERRIN
CONTACT
Assistance Publique Hopitaux De Marseille
Other
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
Acronym: PREVENIR-FIV
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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