Status:
TERMINATED
Evaluation of a Mobile Preconception Lifestyle Programme in Couples Undergoing In Vitro Fertilisation
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsors:
Research Foundation Flanders
KU Leuven
Conditions:
Infertility
Eligibility:
All Genders
Phase:
NA
Brief Summary
The aim of the PreLiFe RCT is to assess the effects of a new mobile preconception lifestyle programme (PreLiFE-programme) for couples undergoing IVF. Couples about to start IVF will be randomized betw...
Detailed Description
Introduction: Infertility and in vitro fertilization (IVF; with or without intracytoplasmic sperm injection, ICSI) result in considerate emotional and financial burden. Increasing evidence suggests th...
Eligibility Criteria
Inclusion
- Infertile heterosexual couples about to start a first IVF-cycle (with or without ICSI) with infertility defined as the failure to achieve a clinical pregnancy after 12 months or more of regular unprotected sexual intercourse
- Women of couples aged ≤ 38 years
- Both partners possess a smartphone
- Both partners understand and speak Dutch
- Written informed consent after been informed on all aspects of the study
Exclusion
- Couples with previous IVF/ICSI treatment cycles
- Couples where one of the partners has special dietary requirements including but not limited to patients that underwent bariatric surgery, patients with coeliac disease or renal disease
- Couples where one of the partners has specific movement's constraints including but not limited to patients with cerebral palsy or hemiparesis
- Couples starting IVF/ICSI with preimplantation genetic diagnosis (PGD)
- Couples using donor gametes or donor embryos
Key Trial Info
Start Date :
January 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2021
Estimated Enrollment :
211 Patients enrolled
Trial Details
Trial ID
NCT03790449
Start Date
January 2 2019
End Date
March 13 2021
Last Update
May 10 2021
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital Antwerp
Antwerp, Belgium, 2000
2
Imelda Hospital Bonheiden
Bonheiden, Belgium, 2820
3
Academic Hospital Sint Jan Bruges-Ostend
Bruges, Belgium, 8000
4
Academic Hospital Diest
Diest, Belgium, 3290