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

Primary Purpose

Infertility

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

PEPCI

About this trial

This is an interventional supportive care trial for Infertility focused on measuring periconceptional habits, Pregnancy, Infertility

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Hôpital Tenon

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

PEPCI group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage of refusal of PEPCI intervention

Assessment of patient satisfaction according Satisfaction Questionnaire (CSQ)

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

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

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

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

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

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

Full Information

NCT ID

NCT02961907

First Posted

November 2, 2016

Last Updated

April 30, 2021

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT02961907

Brief Title

Pathway Taking Into Account PeriConceptional Environment for Infertile Couple

Acronym

PEPCI

Official Title

Pathway Taking Into Account PeriConceptional Environment for Infertile Couple

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

January 22, 2018 (Actual)

Primary Completion Date

October 20, 2020 (Actual)

Study Completion Date

January 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility

Keywords

periconceptional habits, Pregnancy, Infertility

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

No Intervention

Arm Description

Arm Title

PEPCI group

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

PEPCI

Intervention Description

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 Measure Information:

Title

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 Measure Information:

Title

Percentage of refusal of PEPCI intervention

Time Frame