Pathway Taking Into Account PeriConceptional Environment for Infertile Couple

NCT02961907 | Completed

• 1 other identifier: P140934
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Keywords

periconceptional habits; Pregnancy; Infertility

Outcome Measures

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

  3 to 12 months after the initial visit

Secondary Outcomes (8)

• 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

• 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

Study Arms (2)

Control

NO INTERVENTION

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

PEPCI group

EXPERIMENTAL

In the PEPCI group, the standardized assessment of the periconceptional profile is used to adapt the additional standardized intervention.

Procedure: PEPCI

Interventions

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.

PEPCI group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Tenon

Paris, 75020, France

Location

Related Publications (1)

• 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.

  PMID: 32456614 DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Rachel Levy, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: November 11, 2016
• Study Start: January 22, 2018
• Primary Completion: October 20, 2020
• Study Completion: January 12, 2021
• Last Updated: May 3, 2021

Record last verified: 2020-12

Locations

FR (1)