Ignite Creation Date:
2024-05-06 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06100523
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-25
First Post:
2023-09-21
Brief Title:
PREVenting-ENvIronment-Reprotoxic Exposures Before In Vitro Fertilization PREVENIR-FIV
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
Assistance Publique Hopitaux De Marseille
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREVENIR-FIV
Brief 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
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
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 IVFICSI 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
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 IVFICSI 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-A01017-36 | OTHER | ID RCB | None |