Condition category
Urological and Genital Diseases
Date applied
22/07/2019
Date assigned
06/09/2019
Last edited
12/09/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

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

Trial website

https://efp.clinic

Contact information

Type

Scientific

Primary contact

Mrs Andreia Trigo

ORCID ID

http://orcid.org/0000-0002-6604-3279

Contact details

inFertile Life
34b York Way
Kings Cross
London
N1 9AB
United Kingdom
+44(0)7900153648
andreia@infertile-life.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

EFP2019 V.1

Study information

Scientific title

Enhanced Fertility Programme as digital platform for health promotion in patients undergoing fertility treatment: a multicentric controlled trial.

Acronym

EFP

Study hypothesis

Health promotion through a digital platform improves fertility patient outcomes, care and experience.

Ethics approval

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).

Study design

Interventional qualitative multicentric study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

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

Phase

Drug names

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 trial start date

02/09/2019

Overall trial end date

30/04/2020

Reason abandoned (if study stopped)

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

128

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

Greece, Portugal, Russian Federation, Spain, United Kingdom

Trial participating centre

EFP Clinic
Part of inFertile Life 34b York Way Kings Cross
London
N1 9AB
United Kingdom

Trial participating centre

IVF London
Capsian House The Waterfront Elstree Road
London
WD6 3BS
United Kingdom

Trial participating centre

Women's Health
Kirova St. 52
Ufa
450077
Russian Federation

Trial participating centre

Embryoclinic Private Polyclinic - Medically Assisted Reproduction Unit P.C
6 Adrianoupoleos Street Kalamaria
Thessaloniki
55133
Greece

Trial participating centre

Ferticentro
Praceta Robalo Cordeiro
Coimbra
3020-479
Portugal

Trial participating centre

Reproductive Health Group
Centre for reproductive health Daresbury Park Daresbury
Warrington
WA4 4GE
United Kingdom

Sponsor information

Organisation

inFertile Life

Sponsor details

34b York Way
Kings Cross
London
N1 9AB
United Kingdom
07900153648
andreia@infertile-life.com

Sponsor type

Industry

Website

https://efp.clinic

Funders

Funder type

Industry

Funder name

inFertile Life (trading name for Andreia Trigo Consulting Ltd)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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 statement:
The current data sharing plans for this study are unknown and will be available at a later date

Intention to publish date

29/05/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

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.