Pathway Taking Into Account PeriConceptional Environment for Infertile Couple (PEPCI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02961907|
Recruitment Status : Not yet recruiting
First Posted : November 11, 2016
Last Update Posted : November 20, 2017
|Condition or disease||Intervention/treatment|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Pathway Taking Into Account PeriConceptional Environment for Infertile Couple|
|Anticipated Study Start Date :||January 2018|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||November 2021|
No Intervention: Control
The usual routine course includes :
Experimental: PEPCI group
In the PEPCI group, the standardized assessment of the periconceptional profile is used to adapt the additional standardized intervention.
Both parents will receive:
- 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 ]
- Percentage of refusal of PEPCI intervention [ Time Frame: 12 months and 10 months additional in case of pregnancy ]
- Assessment of patient satisfaction according Satisfaction Questionnaire (CSQ) [ Time Frame: 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) [ Time Frame: 12 months and 10 months additional in case of pregnancy ]
- 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 ]
- 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 ]
- Assessment of physical activity according the International Physical Activity Questionnaire (IPAQ) [ Time Frame: 12 months and 10 months additional in case of pregnancy ]
- 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 ]
- 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 ]
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
|Contact: Rachel Levy, MD, PhD||+ 33(0) 1 56 01 78 firstname.lastname@example.org|
|Contact: Emmanuel Cosson, MD, PhDemail@example.com|
|Hôpital Tenon||Not yet recruiting|
|Paris, France, 75020|
|Principal Investigator:||Rachel Levy, MD, PhD||Assistance Publique - Hôpitaux de Paris|