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InfertilityPEPCINCT02961907

Pathway Taking Into Account PeriConceptional Environment for Infertile Couple

A study testing PEPCI in people with Infertility, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Infertility
What is being tested?
PEPCI
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteFrance
Study dates
22 Jan 2018to 12 Jan 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hôpital Tenon

    Paris, 75020

Other trials in France

About this study

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.

Read the 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
Being tested
PEPCI
Keywords
periconceptional habits, Pregnancy, Infertility
Medical subject headings
Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PEPCIProcedure or surgery

    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.
Study groups in NCT02961907
Study groupRoleWhat they receive
ControlNo interventionThe 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 groupExperimentalIn the PEPCI group, the standardized assessment of the periconceptional profile is used to adapt the additional standardized intervention.
Receives: Procedure: PEPCI

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 3 to 12 months after the initial visit

Secondary outcomes (8)

  1. Percentage of refusal of PEPCI intervention

    Measured: 12 months and 10 months additional in case of pregnancy

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

    Measured: 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)

    Measured: 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

    Measured: 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)

    Measured: 12 months and 10 months additional in case of pregnancy

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

    Measured: 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)

    Measured: 12 months and 10 months additional in case of pregnancy

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

    Measured: 12 months and 10 months additional in case of pregnancy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Nov 2016 (estimated)
  2. Study start22 Jan 2018
  3. Primary completion20 Oct 2020
  4. Study completion12 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02961907
Sponsor's protocol ID
P140934
Acronym
PEPCI
Status last verified
Dec 2020
First submitted
2 Nov 2016
Last updated
3 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 32456614

Questions about this trial

What is this clinical trial studying?

A study testing PEPCI in people with Infertility, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02961907, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.

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