Pathway Taking Into Account PeriConceptional Environment for Infertile Couple

NCT ID: NCT02961907

Last Updated: 2021-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-22
• Study Completion Date: 2021-01-12

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.

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.

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.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

PEPCI group

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

Group Type: EXPERIMENTAL

PEPCI

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rachel Levy, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Tenon

Paris, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 32456614 (View on PubMed)

Other Identifiers

P140934

Identifier Type: -

Identifier Source: org_study_id