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Completed

NCT Number: NCT02961907

Pathway Taking Into Account PeriConceptional Environment for Infertile Couple

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Tenon

Paris, 75020, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PEPCI

Procedure

Both parents will receive:

  • consultation with a psychiatrist then psychologist follow-up if required, addiction specialist physician consultation then liaison nurse follow-up if required
  • endocrinologist consultation then dietitian follow-up if required
  • actiphysician consultation and follow-up if required This program will be added to the usual routine course Both parents will receive a 3 months personalized follow-up if required from the multi disciplinary consultation and before the first ART attempt.

Primary outcomes

  1. Clinical pregnancy will be obtained from evidence of gestational sac on ultrasound exam at 6 weeks of amenorrhea either after the first ART attempts

    Time frame: 3 to 12 months after the initial visit

Secondary outcomes

  1. Percentage of refusal of PEPCI intervention

    Time frame: 12 months and 10 months additional in case of pregnancy

  2. Assessment of patient satisfaction according Satisfaction Questionnaire (CSQ)

    Time frame: 12 months and 10 months additional in case of pregnancy

  3. Assessment of impact on the health control according the Multidimensional Health Locus of Control Scale (french version)

    Time frame: 12 months and 10 months additional in case of pregnancy

  4. Assessment of weight using Body mass index (BMI) expressed in units of kg/m2

    Time frame: 12 months and 10 months additional in case of pregnancy

  5. Assessment of health risk associated with excess fat around the waist using Waist Circumference WC ( measured in centimeters)

    Time frame: 12 months and 10 months additional in case of pregnancy

  6. Assessment of physical activity according the International Physical Activity Questionnaire (IPAQ)

    Time frame: 12 months and 10 months additional in case of pregnancy

  7. Assessment of the quality and patterns of sleep according The Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 12 months and 10 months additional in case of pregnancy

  8. Assessment of Anxiety and depressive disorders according Hospital Anxiety and Depression scale (HAD)

    Time frame: 12 months and 10 months additional in case of pregnancy

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: PEPCI

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Nov 11, 2016
Registry last updated
May 3, 2021

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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