Understanding fertility in women with chronic kidney disease
| ISRCTN | ISRCTN23312225 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23312225 |
| IRAS number | 285546 |
| Secondary identifying numbers | CPMS 49608, IRAS 285546 |
- Submission date
- 26/07/2021
- Registration date
- 28/09/2021
- Last edited
- 28/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Chronic kidney disease (CKD) is a long-term condition where the kidneys don't work as well as they should. Rates of CKD continue to rise in women of reproductive age, with 15% of patients less than 50 years old. This study aims to investigate how CKD affects the reproductive system, ovarian reserve (the number and quality of eggs) and inflammation. It also aims to investigate if increasing the intensity of dialysis improves fertility.
Who can participate?
Women aged 18-49 years with chronic kidney disease, or women between 18-49 years old with no medical history and no active or previous disease/treatment which could have affected their fertility.
What does the study involve?
The study will involve a minimum of one and a maximum of three visits. At each visit blood samples will be taken and a transvaginal scan will be carried out.
What are the possible benefits and risks of participating?
Participation will help the researchers to improve the care for women with kidney disease who have fertility problems. A fertility specialist will contact participants to give them their results, explain what they mean and how best to act on them if there is a problem. Their GP will be informed of any findings and if they need emotional support counsellors will be available as part of the study. There are no risks of taking part. The transvaginal ultrasound scan is safe and has no significant risks associated with it. Occasionally there is minimal discomfort during the scan but participants' wellbeing will be the upmost priority during the scan.
Where is the study run from?
King’s Fertility, London (UK)
When is the study starting and how long is it expected to run for?
March 2000 to April 2023
Who is funding the study?
The Fetal Medicine Foundation (UK)
Who is the main contact?
Mahua Bhaduri
mahua.bhaduri@kingsfertility.co.uk
Contact information
Scientific
King's Fertility
First Floor
The Fetal Medicine Research Institute
16-20 Windsor Walk
London
SE5 8BB
United Kingdom
| Phone | +44 (0)7792732092 |
|---|---|
| Mahua.bhaduri@kingsfertility.co.uk |
Study information
| Study design | Observational; Design type: Cross-sectional |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | 40207_PIS_v2.0_21Jun21.docx |
| Scientific title | Fertility Evaluation in ReNal disease (FERN) |
| Study acronym | FERN |
| Study objectives | 1. Patients with chronic kidney disease (CKD) will have reduced ovarian reserve compared to healthy controls. This will be demonstrated by blood markers and a transvaginal scan 2. Female CKD patients will have dysregulation of the hypothalamic-pituitary-ovarian (HPO) axis 3. Inflammatory markers in CKD women will be higher than normal controls |
| Ethics approval(s) | Approved 13/07/2021, London - Hampstead Research Ethics Committee (Ground Floor, Temple Quay, House 2, The Square, Bristol, BS1 6PN, UK; +44 (0)207 104 8345, +44 (0)207 104 8328; hampstead.rec@hra.nhs.uk), REC ref: 21/PR/0754 |
| Health condition(s) or problem(s) studied | Chronic kidney disease |
| Intervention | Study design: Multi-centre prospective observational cohort with blood sample collection and transvaginal ultrasound. Setting: specialist renal clinics in the UK Study duration per participant: Up to 6 months Patients will be contacted and asked to fill in a patient questionnaire and sign patient consent forms. Patients who have CKD and are not starting intensive haemodialysis will have at least one visit and a maximum of three visits with blood tests and a transvaginal scan at King's Fertility. Patients who will be starting on haemodialysis will have three visits/sample collection times: prior to starting HD treatment, at 3 months of treatment and at 6 months. They will be also offered a transvaginal scan at each visit at King's Fertility. All patients will be asked to fill out a validated questionnaire on how fertility impacts their quality of life. |
| Intervention type | Other |
| Primary outcome measure | 1. Fertility assessed using blood markers (AMH, oestradiol, FSH, LH, progesterone, testosterone) and transvaginal ultrasound scan at baseline, 3 months and 6 months |
| Secondary outcome measures | 1. The relationship of infertility, chronic kidney disease and chronic inflammation investigated using blood markers (O-link inflammatory panel) at baseline, 3 months and 6 months 2. Quality of life measured by a qualitative survey at baseline |
| Overall study start date | 01/03/2000 |
| Completion date | 01/04/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 49 Years |
| Sex | Female |
| Target number of participants | Planned Sample Size: 200; UK Sample Size: 200 |
| Key inclusion criteria | Study group: 1. Women with CKD Stages 1-5 including those with renal transplants and on dialysis 2. ≥18 years old but ≤49 years old 3. Willing and able to provide written informed consent Control group: 1. Women aged 18-49 years 2. Male factor infertility 3. Willing and able to provide written informed consent |
| Key exclusion criteria | Study group: 1. Pregnant patients or those who are currently breastfeeding 2. Patient who have active or previous disease/treatment which could have affected their ovarian reserve i.e. chemotherapy, radiotherapy, ovarian surgery 3. Patients who require a translator Control group: 1. Patients who have active or previous disease/treatment which could have affected their fertility 2. Patients who have female factor infertility, i.e. tubal factor, anovulatory disorders, endometriosis, fibroids, low ovarian reserve 3. Patients who have a known medical condition 4. Patient who require a translator |
| Date of first enrolment | 01/08/2021 |
| Date of final enrolment | 01/10/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
London
SE5 9RS
United Kingdom
Leicester
LE1 5WW
United Kingdom
Whitechapel Rd
Whitechapel
E1 1FR
United Kingdom
Arnot Hill Park
Arnold
Nottingham
NG5 0TE
United Kingdom
South Wharf Road
London
W2 1BL
United Kingdom
London
SE1 7EH
United Kingdom
Sponsor information
Hospital/treatment centre
Mr Rahman Ahmed
The R&I office
161 Denmark Hill
London
SE5 8EF
England
United Kingdom
| Phone | +44 (0)20 3299 1980 |
|---|---|
| kch-tr.research@nhs.net | |
| Website | https://www.kch.nhs.uk/ |
"ROR" |
https://ror.org/01n0k5m85 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- FMF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/04/2024 |
|---|---|
| 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 | The protocol will not be shared. Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 2.0 | 21/06/2021 | 04/08/2021 | No | Yes |
| Participant information sheet | PIS for control group version 2.0 |
21/06/2021 | 04/08/2021 | No | Yes |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- 40207_PIS_v2.0_21Jun21.docx
- 40207_PIS_control_v2.0_21Jun21.docx
- PIS for control group
Editorial Notes
26/07/2021: Trial's existence confirmed by the NIHR.
