Infertility Clinical Trial
— PEPCIOfficial title:
Pathway Taking Into Account PeriConceptional Environment for Infertile Couple
Verified date | December 2020 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Infertility is defined as the inability to conceive after 12 months of unprotected intercourse, It affects approximately one in six couples pregnancy. Many lifestyle factors of the couple's pre and peri-conceptional environment (weight, diet, alcohol, tobacco, coffee, drugs, exercise, stress, sleep, pollution...) are risk factors for infertility. Weight gain, in both members of the couple, is associated with an increased risk of Assisted Reproduction Technology (ART) failure and adverse pregnancy outcome, while healthy lifestyle makes the risk of infertility three times less likely to happen. Idiopathic infertility may greatly benefit from lifestyle factors optimization.
Status | Completed |
Enrollment | 48 |
Est. completion date | January 12, 2021 |
Est. primary completion date | October 20, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - Couple attending a visit in an ART reproductive center (1st care regardless of the center regardless of the number of attempts in the center or in another center) - Heterosexual infertile couple (absence of pregnancy after 12 months of unprotected intercourse) - Men aged from 18 to 45 and women aged from 18 to 38 - Couple having not shown any opposition to the use of their data (observational study) and given their informed written consent to collect their biological samples - Couple with good understanding of the French language - Couple with computer equipment including webcam and internet access at home - Affiliation to the French health insurance organism - No-cons to the practice of adapted physical activity (non stabilized disease: diabetes, anemia, aplastic anemia, severe malnutrition, severe osteoporosis, heart or lung disease) - Signing of the informed consent form Exclusion Criteria: - BMI upper 40 for one or both members of the couple - Viral infection for one or both members of the couple (infection with HIV, Hepatitis B or C) - Ongoing pregnancy - One or both member of the couple medically treated for diabetes mellitus - One or both member of the couple medically treated for a psychotic disorder - Inability to comply with care program" - Couple already enroll in the study |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Tenon | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical pregnancy will be obtained from evidence of gestational sac on ultrasound exam at 6 weeks of amenorrhea either after the first ART attempts | 3 to 12 months after the initial visit | ||
Secondary | Percentage of refusal of PEPCI intervention | 12 months and 10 months additional in case of pregnancy | ||
Secondary | Assessment of patient satisfaction according Satisfaction Questionnaire (CSQ) | 12 months and 10 months additional in case of pregnancy | ||
Secondary | Assessment of impact on the health control according the Multidimensional Health Locus of Control Scale (french version) | 12 months and 10 months additional in case of pregnancy | ||
Secondary | Assessment of weight using Body mass index (BMI) expressed in units of kg/m2 | 12 months and 10 months additional in case of pregnancy | ||
Secondary | Assessment of health risk associated with excess fat around the waist using Waist Circumference WC ( measured in centimeters) | 12 months and 10 months additional in case of pregnancy | ||
Secondary | Assessment of physical activity according the International Physical Activity Questionnaire (IPAQ) | 12 months and 10 months additional in case of pregnancy | ||
Secondary | Assessment of the quality and patterns of sleep according The Pittsburgh Sleep Quality Index (PSQI) | 12 months and 10 months additional in case of pregnancy | ||
Secondary | Assessment of Anxiety and depressive disorders according Hospital Anxiety and Depression scale (HAD) | 12 months and 10 months additional in case of pregnancy |
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