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Trial record 19 of 432 for:    Recruiting, Not yet recruiting, Available Studies | "Infertility"

Pathway Taking Into Account PeriConceptional Environment for Infertile Couple (PEPCI)

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ClinicalTrials.gov Identifier: NCT02961907
Recruitment Status : Recruiting
First Posted : November 11, 2016
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Infertility Procedure: PEPCI Not Applicable

Detailed Description:

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.

Firstly, at their first visit in any 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Pathway Taking Into Account PeriConceptional Environment for Infertile Couple
Actual Study Start Date : January 22, 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
No Intervention: Control

The usual routine course includes :

  • a clinico-biological evaluation of infertility causes
  • a laboratory staff and decision of therapeutic strategy and decision of a therapeutic strategy
  • collection of blood and sperm samples
Experimental: PEPCI group
In the PEPCI group, the standardized assessment of the periconceptional profile is used to adapt the additional standardized intervention.
Procedure: PEPCI

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 Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Couple attending for the first time an ART reproductive 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 35 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"

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02961907


Contacts
Contact: Rachel Levy, MD, PhD + 33(0) 1 56 01 78 02 rachel.levy@aphp.fr
Contact: Emmanuel Cosson, MD, PhD emmanuel.cosson@aphp.fr

Locations
France
Hôpital Tenon Recruiting
Paris, France, 75020
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Rachel Levy, MD, PhD Assistance Publique - Hôpitaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02961907     History of Changes
Other Study ID Numbers: P140934
First Posted: November 11, 2016    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
periconceptional habits
Pregnancy
Infertility

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female