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Fit-for-Fertility Multicenter Randomized Controlled Trial (FFF)

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ClinicalTrials.gov Identifier: NCT03908099
Recruitment Status : Recruiting
First Posted : April 9, 2019
Last Update Posted : January 26, 2021
Sponsor:
Collaborators:
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Ferring Pharmaceuticals
Information provided by (Responsible Party):
Jean-Patrice Baillargeon, Université de Sherbrooke

Brief Summary:

Infertility affects approximately 10-15% of couples and one of its important modifiable risk factor is obesity, which affects 19% of Canadian women of reproductive age. Accordingly, many organizations have recommended that women should be assisted to adopt a healthy lifestyle prior to conception and maintain it during pregnancy. We therefore propose to conduct a multicenter randomized controlled trial (RCT) assessing the lifestyle intervention Fit-For-Fertility in women with infertility and obesity. Our hypothesis is that the Fit-For-Fertility program is an efficient and low cost solution to improve access to motherhood for women suffering from obesity and infertility.

To test our hypothesis, seven fertility clinics having a good ethnic diversity will participate in this RCT and recruit a total of 616 women with obesity (BMI according to ethnicity) who consult at the fertility clinic. Participants will be randomly allocated to one of these two groups: the intervention group will be invited to participate in the Fit-for Fertility Program alone for 6 months and then in combination with usual fertility treatments; while the control group will receive standard fertility treatments from randomisation. The aim of the Fit-for Fertility Program will be to implement progressive and sustainable lifestyle changes, using 1) individual sessions with a dietitian and a kinesiologist every 6-12 weeks, for a total of 18 months or until the end of pregnancy; and 2) eight educational group sessions. Evaluation visits will take place prior to randomisation and then every 6 months for 18 months. Women who become pregnant will be evaluated early during pregnancy and at 26 weeks of gestation. Clinical outcomes will be assessed after a total follow up of 24 months.

Anticipated contributions: The results of our multicenter RCT will provide important data on the importance of a lifestyle program supporting women with obesity consulting in fertility clinics, in order to improve their fertility and response to ART, as well as helping them to have a healthy baby. This study will also provide valuable information on potential cost savings for individuals and the healthcare system.


Condition or disease Intervention/treatment Phase
Obesity Infertility, Female Behavioral: Fit-For-Fertility program Other: Standard of care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 616 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A pragmatic, multicenter, two-arm, parallel randomized controlled trial comparing the Fit-for-Fertility lifestyle program to usual fertility care
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fit-for-Fertility Multicenter Randomized Controlled Trial: Improving Reproductive, Maternal and Neonatal Outcomes in Obese and Infertile
Actual Study Start Date : April 3, 2019
Estimated Primary Completion Date : April 2025
Estimated Study Completion Date : October 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
Experimental: Fit-For-Fertility program
The experimental intervention will be the Fit-for-Fertility Program alone for the first 6 months, then in combination with usual fertility care for an additional 12 months and thereafter, usual fertility care can continue to be provided alone for a maximum follow-up of 24 months. The lifestyle program is provided for a maximum of 18 months if there is no pregnancy, or otherwise, up to the end of pregnancy or to a total study follow-up of 24 months (whichever comes first).
Behavioral: Fit-For-Fertility program
The Fit-for-Fertility Program aims at implementing progressive and sustainable lifestyle changes. Participants will attend individual sessions with a dietitian and a kinesiologist every 6 weeks for the first 6 months, then every 8 weeks for the 6 following months, and then every 12 weeks until end of the study. Follow-up by telephone/e-mail will be offered between in-person meetings. These professionals will be trained in motivational counselling skills. Participants will also benefit from weekly group sessions divided into 2 parts: 1) Workshops covering 8 different topics (45 minutes) addressing healthy lifestyle and 2) Supervised classes of physical activity where one of 8 different types of exercise (45 minutes) will be practiced. Women will be required to attend all 8 different sessions within the first 6 months. Pregnant women will be met to set new lifestyle objectives specific to pregnancy, including optimal gestational weight gain based on the Institute of Medicine guidelines.

Active Comparator: Standard of care
The control intervention will consist of immediate initiation of usual fertility care, as recommended by each fertility specialist, for a maximum of 24 months.
Other: Standard of care
The control intervention will consist of immediate initiation of usual fertility care, as recommended by each fertility specialist, for a maximum of 24 months. The experimental intervention will be the Fit-for-Fertility Program alone for the first 6 months, then in combination with usual fertility care for an additional 12 months and thereafter, usual fertility care can continue to be provided alone for a maximum follow-up of 24 months. The lifestyle program is provided for a maximum of 18 months if there is no pregnancy, or otherwise, up to the end of pregnancy or to a total study follow-up of 24 months (whichever comes first).
Other Name: Fertilty care




Primary Outcome Measures :
  1. Live birth rate [ Time Frame: 24 months ]
    Cumulative incidence of live birth, based on medical record/questionnaire.


Secondary Outcome Measures :
  1. Fertility Outcomes - Rate of biochemical pregnancy [ Time Frame: 24 months ]
    Confirmed by a positive serum β-hCG), based on medical record.

  2. Fertility Outcomes - Rate of ongoing pregnancy [ Time Frame: 24 months ]
    Viable pregnancy of ≥10 weeks of gestation, based on medical record.

  3. Fertility Outcomes - Rate of spontaneous miscarriage [ Time Frame: 24 months ]
    <22 gestational weeks, based on medical record/questionnaire.

  4. Fertility Outcomes - Rate of multiple gestation [ Time Frame: 24 months ]
    More than one fetal heart beat, based on medical record.

  5. Fertility Outcomes - Rate of spontaneous pregnancy [ Time Frame: 24 months ]
    Without following MAR procedures, based on medical record/questionnaire.

  6. Fertility Outcomes - Rate of pregnancy following MAR procedures [ Time Frame: 24 months ]
    By procedures, based on medical record.

  7. Fertility Outcomes - Doses of fertility medications per participant [ Time Frame: 24 months ]
    required during MAR cycles, based on medical record.

  8. Fertility Outcomes - Number of MAR and/or ART cycles per participant [ Time Frame: 24 months ]
    Number of MAR and/or ART cycles, based on medical record.

  9. Fertility Outcomes - Frequency of embryo transfers [ Time Frame: 24 months ]
    After IVF procedures, based on medical record.

  10. Fertility Outcomes - Frequency of complications due to MAR procedures [ Time Frame: 24 months ]
    All type of complications directly related to MAR, based on medical record.

  11. Lifestyle outcomes - Nutrient intake [ Time Frame: 18 months or end of pregnancy ]
    Using a web-based, food frequency questionnaire.

  12. Lifestyle outcomes - Physical activity behaviours [ Time Frame: 18 months or end of pregnancy ]
    Using the International Physical Activity Questionnaires (IPAQ).

  13. Lifestyle outcomes - Measures of physical activity [ Time Frame: 18 months or end of pregnancy ]
    Daily energy expenditure, time spent in various physical activity intensities and step count, using a blinded Fitbit Flex 2 wristband for 7 consecutive days following the visit.

  14. Lifestyle outcomes - Physical fitness level [ Time Frame: 18 months or end of pregnancy ]
    Using the six-minute walk test.

  15. Lifestyle outcomes - Other lifestyles [ Time Frame: 18 months or end of pregnancy ]
    such as alcohol, tobacco and drugs, using a questionnaire.

  16. Lifestyle outcomes - Sleep duration and quality [ Time Frame: 18 months or end of pregnancy ]
    Using the Pittsburgh Sleep Quality Index.

  17. Lifestyle outcomes - Sleep stages [ Time Frame: 18 months or end of pregnancy ]
    Using the Fitbit Flex 2 wristband.

  18. Lifestyle outcomes - Perceived competence [ Time Frame: 18 months or end of pregnancy ]
    Using the Perceived Competence Scale.

  19. Lifestyle outcomes - Readiness [ Time Frame: 18 months or end of pregnancy ]
    Using a conviction/confidence and readiness questionnaire

  20. Lifestyle outcomes - Anxiety/depression [ Time Frame: 18 months or end of pregnancy ]
    Using the Hospital Anxiety and Depression Scale (HADS).

  21. Anthropometric measures - BMI [ Time Frame: 18 months or end of pregnancy ]
    weight and height will be combined to report BMI in kg/m^2; measures will be performed using a standard calibrated scale and stadiometer.

  22. Anthropometric measures - Fat percentage [ Time Frame: 18 months or end of pregnancy ]
    Using a foot-to-foot bioimpedance scale, in sites having this equipment.

  23. Blood markers - Sex steroids [ Time Frame: 18 months or end of pregnancy ]
    Fasting levels.

  24. Blood markers - Endocrine panel [ Time Frame: 18 months or end of pregnancy ]
    Fasting levels.

  25. Blood markers - Metabolic panel [ Time Frame: 18 months or end of pregnancy ]
    Fasting levels.

  26. Incremental health-related cost-effectiveness ratio of live birth [ Time Frame: 24 months ]
    Using costs questionnaires and other sources of data that will be aggregated at this reported value.

  27. Pregnancy outcomes - Gestational weight gain [ Time Frame: 24 months ]
    estimated by subtracting weight at the research visit closest to the onset of pregnancy from both the weight at the last research visit and the last weight available in the record.

  28. Pregnancy outcomes - Gestational complications [ Time Frame: 24 months ]
    such as gestational diabetes, gestational hypertensive disorders, thromboembolism, preterm birth, late fetal loss, stillbirth and post-partum hospital stay >7 days.

  29. Neonatal outcomes - Birth weight [ Time Frame: 24 months ]
    Based on medical record.

  30. Neonatal outcomes - Apgar score [ Time Frame: 24 months ]
    Based on medical record.

  31. Neonatal outcomes - Hypoglycemia [ Time Frame: 24 months ]
    Based on medical record.

  32. Neonatal outcomes - Jaundice [ Time Frame: 24 months ]
    Based on medical record.

  33. Neonatal outcomes - Birth trauma [ Time Frame: 24 months ]
    Based on medical record.

  34. Neonatal outcomes - Admission to neonatal intensive care unit [ Time Frame: 24 months ]
    Based on medical record.

  35. Neonatal outcomes - Death [ Time Frame: 24 months ]
    Neonatal death up to 28 days of life, based on medical record.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Infertility defined as (a) failure to achieve a clinical pregnancy after ≥12 months of regular unprotected sexual intercourse, (b) not conceiving after having tried ≥6 months in women with irregular menstrual cycles or ≥35 years of age; or (c) women with an established cause of infertility;
  2. Aged between 18 and 40 years; and
  3. Obesity (BMI ≥ 30 kg/m² or 27 kg/m² for Asian and Latin American), or overweight for women with PCOS (BMI ≥ 27 kg/m²).

Exclusion Criteria:

  1. Any uncontrolled medical or mental condition that contra-indicates fertility treatments, based on clinical judgment of the fertility specialist;
  2. If the only clinically indicated MAR procedure is IVF (e.g. bilateral tubal factor, severe male factor, etc.) or in case of insemination with donor, because natural conception is impossible or highly unlikely;
  3. Recurrent spontaneous abortions (>2 miscarriages at less than 22 weeks of gestation) within the last 12 months (with evidence of conception, such as positive β-hCG), because these women do not have difficulty to conceive.
  4. Previously diagnosed uncontrolled eating disorder or major depression that would contra-indicate the initiation of a lifestyle intervention;
  5. A high level of depressive state, as determined by a score for depression on the Hospital Anxiety and Depression Scale (HADS) ≥ 15, since that would contra-indicate the initiation of a lifestyle intervention;
  6. Planning for or past history of bariatric surgery;
  7. Planning for or engaging in another intensive lifestyle intervention (that includes face-to-face visits every 8 weeks or less, which would be similar to the intervention tested);
  8. Inability to understand the language in which group sessions will be provided in the participating center, i.e. French in Quebec province and English in other provinces; and
  9. Planning to be unable to attend research visits at the participating center for the next 18 months, due to moving in another region, for example.

Information from the National Library of Medicine

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): NCT03908099


Contacts
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Contact: Farrah Jean-Denis, MSc (819) 346-1110 ext 12814 farrah.jean-denis.ciussse-chus@ssss.gouv.qc.ca

Locations
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Canada, Alberta
Pacific Centre for Reproductive Medicine Withdrawn
Edmonton, Alberta, Canada
Canada, British Columbia
Olive Fertility Centre Recruiting
Vancouver, British Columbia, Canada
Principal Investigator: Elizabeth Taylor, MD         
Canada, New Brunzwick
IWK Health Centre Recruiting
Halifax, New Brunzwick, Canada
Principal Investigator: Renda Bouzayen, MD         
Canada, Ontario
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada
Principal Investigator: Ellen Greenblatt, MD         
Canada, Quebec
Centre hospitalier de l'Université de Montréal (CHUM) Recruiting
Montréal, Quebec, Canada
Principal Investigator: Carole N. Kamga-Ngandé, MD         
Sub-Investigator: Ariane Godbout, MD         
Centre hospitalier de l'Université Laval Recruiting
Québec, Quebec, Canada
Sub-Investigator: Weilin Kong, MD         
Principal Investigator: Anne-Sophie Morisset, PhD         
Centre hospitalier universitaire de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Farrah Jean-Denis, M.Sc.    819-346-1110 ext 12814    farrah.jean-denis.ciussse-chus@ssss.gouv.qc.ca   
Principal Investigator: Jean-Patrice Baillargeon, MD         
Sub-Investigator: Belina Carranza-Mamane, MD         
Sub-Investigator: Marie-Hélène Pesant, MD         
Sub-Investigator: Marie-France Langlois, MD         
Sub-Investigator: Thomas Poder, PhD         
Sub-Investigator: William Fraser, MD         
Sub-Investigator: Frances Gallagher, PhD         
Sponsors and Collaborators
Université de Sherbrooke
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Ferring Pharmaceuticals
Investigators
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Principal Investigator: Jean-Patrice Baillargeon, MD, MSc Université de Sherbrooke
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Responsible Party: Jean-Patrice Baillargeon, Professor of Medicine, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT03908099    
Other Study ID Numbers: CIHR/PJT-155973
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: January 26, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jean-Patrice Baillargeon, Université de Sherbrooke:
Lifestyle intervention
Weight loss
Obesity
Infertility
Interdisciplinary program
Additional relevant MeSH terms:
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Infertility
Infertility, Female