Enhanced fertility programme: developing an accessible, safe and cost-effective digital solution to improve fertility
| ISRCTN | ISRCTN12487925 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12487925 |
| Secondary identifying numbers | EFP2019 V.1 |
- Submission date
- 22/07/2019
- Registration date
- 06/09/2019
- Last edited
- 12/09/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English Summary
Background and study aims
The purpose of the study is to look into factors that affect fertility: healthy lifestyles, ability to cope with treatment, quality of life, patient satisfaction and experience.
The study will introduce the Enhanced Fertility Programme to patients receiving treatment in several fertility centres in Europe. The programme includes access to a digital platform and one to one coaching consultations (phone or Skype). The goal is to help improve health and lifestyle over six months. We will assess the impact of the programme on patient reported outcome measures such as adherence to healthy lifestyles, ability to cope with treatment, quality of life, patient satisfaction, experience and pregnancy status.
Who can participate?
Patients undergoing fertility treatment at the research sites, age 20-37, English speaking.
What does the study involve?
The study is looking at healthy lifestyles, ability to cope with treatment, quality of life, patient satisfaction, experience and pregnancy status in two participant groups. Patients in Group A will receive normal care as suggested by their doctor and complete an online questionnaire at baseline and 6 months later. Patients in Group B will receive normal care as suggested by their doctor, have access to the Enhanced Fertility Programme (online platform and one to one coaching) and complete an online questionnaire at baseline 6 weeks, 12 weeks, 18 weeks and 24 weeks.
What are the possible benefits and risks of participating?
There are no known direct risks associated with this study. Clinical treatment will be the same whether patients participate or not in the study. Patients may experience better health and fertility. The information we get from this study may help us improve the care of future patients.
Where is the study run from?
The Enhanced Fertility Programme clinic, London, UK
When is the study starting and how long is it expected to run for?
October 2019 to April 2020
Who is funding the study?
inFertile Life (trading name for Andreia Trigo Consulting Ltd), UK
Who is the main contact?
Andreia Trigo
andreia@infertile-life.com
Contact information
Scientific
inFertile Life
34b York Way
Kings Cross
London
N1 9AB
United Kingdom
 ORCID ID |
0000-0002-6604-3279 |
|---|---|
| Phone | +44(0)7900153648 |
| andreia@infertile-life.com |
Study information
| Study design | Interventional qualitative multicentric study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Enhanced Fertility Programme as digital platform for health promotion in patients undergoing fertility treatment: a multicentric controlled trial. |
| Study acronym | EFP |
| Study hypothesis | Health promotion through a digital platform improves fertility patient outcomes, care and experience. |
| Ethics approval(s) | 1. Approved 27/08/2019, Ethics committee at IVF London (Capsian House, The Waterfront, Elstree Road, WD6 3BS; deider.harrell@ivflondon.co.uk), ref: n/a 2. Approved 31/08/2019, Ethics committee at Women's Health (Kirova St. 52, Ufa, 450077, Russia; e.fazlyeva@eko-rb.ru), ref: n/a 3. Approved 02/08/2019, Ethics committee at Embryoclinic Private Polyclinic - Medically Assisted Reproduction Unit P.C. (6 Adrianoupoleos Street, Kalamaria 55133, Thessaloniki, Greece; k.bimpa@embyoclinic.eu), ref: n/a 4. Approved 04/09/2019, Ethics committee at Ferticentro (Praceta Robalo Cordeiro, 3020-479 Coimbra, Portugal; vladsilva@ferticentro.pt), ref: n/a 5. Approved 06/09/2019, Ethics committee at Reproductive Health Group (Centre for reproductive health, Daresbury Park, Daresbury, Cheshire, WA4 4GE; aeckersley@reproductivehealthgroup.co.uk), ref: n/a 6. Approved 09/09/2019, Ethics committee at IVF Spain (Ansaldo 13 03540 Playa De San Juan, Alicante, Spain; mj.peral@ivf-spain.com). |
| Condition | Primary and Secondary Infertility, ovulatory disorders, male factor and unexplained infertility |
| Intervention | The study has two phases, one after the other: Phase 1 will be looking at standard of care, with at least 64 patients recruited in October 2019, answering a questionnaire. Phase 2 will start after (November 2019) with 64 patients receiving standard of care and the intervention (Enhanced Fertility Programme). This includes access to a digital platform for health promotions and one to one coaching for behaviour modification. Phase 2 patients will answer a questionnaire at baseline, 6 weeks, 12 weeks, 18 weeks and 24 weeks. Number of patients for each phase was calculated for a 95% confidence interval and 5% margin of error |
| Intervention type | Behavioural |
| Primary outcome measure | Measured at: baseline, 6 weeks, 12 weeks, 18 weeks and 24 weeks through online questionnaire completed by participants: 1. Pregnancy status: nominal scale (yes/no) 2. Adherence to healthy lifestyles: Likert scale (Very good, good, nor good nor bad, poor, very poor) 3. Ability to cope with treatment: Likert scale (completely, a great deal, moderately, not much, nor at all). 4. Patient satisfaction: likert scale (extremely likely, likely, neither, unlikely, extremely unlikely). 5. Quality of life: FertiQoL |
| Secondary outcome measures | Measured at 6 months through online questionnaire completed by participants: 1. Accessibility to health promotion strategies: Likert scale (completely, a great deal, moderately, not much, not at all). 2. Inequality in fertility care: Likert scale (completely, a great deal, moderately, not much, not at all). |
| Overall study start date | 02/09/2019 |
| Overall study end date | 30/04/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 128 |
| Participant inclusion criteria | 1. Heterosexual couples or women seeking fertility treatment at one of the trial participating centres 2. Age 20-37 3. English speaking 4. Capacity to understand and use a computer with internet access 5. Diagnosed with primary or secondary infertility related to unexplained infertility, ovulatory disorders or male factor infertility |
| Participant exclusion criteria | 1. Any anatomical congenital gynaecological or urological abnormalities |
| Recruitment start date | 01/10/2019 |
| Recruitment end date | 30/04/2020 |
Locations
Countries of recruitment
- England
- Greece
- Portugal
- Russian Federation
- Spain
- United Kingdom
Study participating centres
34b York Way
Kings Cross
London
N1 9AB
United Kingdom
The Waterfront
Elstree Road
London
WD6 3BS
United Kingdom
Ufa
450077
Russian Federation
Kalamaria
Thessaloniki
55133
Greece
Coimbra
3020-479
Portugal
Daresbury Park
Daresbury
Warrington
WA4 4GE
United Kingdom
Sponsor information
Industry
34b York Way
Kings Cross
London
N1 9AB
United Kingdom
| Phone | 07900153648 |
|---|---|
| andreia@infertile-life.com | |
| Website | https://efp.clinic |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 29/05/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Intend to publish main results and conclusions of the study. The study report will be completed by May 2019 and sent to all study sites. Dissemination at congresses, including ESHRE. Relevant publications and magazines in reproductive health. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Editorial Notes
12/09/2019: Ethics approval was added for IVF Spain.
06/09/2019: Ethics approval was added for Reproductive Health Group.
04/09/2019: Trial’s existence confirmed by Embryoclinic Private Polyclinic - Medically Assisted Reproduction Unit P.C.
