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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.
To evaluate and optimize periconceptional habits (diet and lifestyle factors) of unfertile couple may have favorable impact on conception and pregnancy.
The investigators propose to undertake a controlled trial of the efficiency of an integrated global care program. This trial of an intervention on lifestyle factors will be compared with the ""cohort multiple randomised controlled trial"" methodology in order to strengthen external validity by limiting bias that may result from initial consent to randomisation, or from deception of allocated treatment.
At any visit in a participating ART center, all attending couples will be invited to participate in an observational survey in order to allow access to their data. In this whole cohort, all eligible couples will be identified as consultations go. An ""on the fly"" randomisation process (ration 2 usual / 1 experimental) will select candidate couples from all eligible ones, who will be ten offered the experimental PEPCI intervention. In case of refusal of the experimental care, they will be given the usual care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | The usual routine course includes :
| |
| PEPCI group | Experimental | In the PEPCI group, the standardized assessment of the periconceptional profile is used to adapt the additional standardized intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEPCI | Procedure | Both parents will receive:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of refusal of PEPCI intervention | 12 months and 10 months additional in case of pregnancy | |
| Assessment of patient satisfaction according Satisfaction Questionnaire (CSQ) | 12 months and 10 months additional in case of pregnancy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rachel Levy, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Tenon | Paris | 75020 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32456614 | Derived | Dupont C, Aegerter P, Foucaut AM, Reyre A, Lhuissier FJ, Bourgain M, Chabbert-Buffet N, Cedrin-Durnerin I, Selleret L, Cosson E, Levy R. Effectiveness of a therapeutic multiple-lifestyle intervention taking into account the periconceptional environment in the management of infertile couples: study design of a randomized controlled trial - the PEPCI study. BMC Pregnancy Childbirth. 2020 May 26;20(1):322. doi: 10.1186/s12884-020-2855-9. |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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|
| 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 |
| Assessment of weight using Body mass index (BMI) expressed in units of kg/m2 | 12 months and 10 months additional in case of pregnancy |
| 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 |
| Assessment of physical activity according the International Physical Activity Questionnaire (IPAQ) | 12 months and 10 months additional in case of pregnancy |
| 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 |
| Assessment of Anxiety and depressive disorders according Hospital Anxiety and Depression scale (HAD) | 12 months and 10 months additional in case of pregnancy |