FENOX: Fibroids and Endometriosis Study Oxford – A Study into the Biology of Uterine Fibroids and Endometriosis.

Not Applicable

• Conditions: Endometriosis, uterine fibroids.; Not Applicable; Endometriosis

• Registration Number: ISRCTN13560263
• Lead Sponsor: niversity of Oxford, Clinical Trials and Research Governance Team

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-23
• Last Update Posted: 1 April 2024
• Study Completion: 2028-03-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 2400

Inclusion Criteria

1.Participant is willing and able to give informed consent for participation in the study.
2.Female, aged 18 years or above (before menopause).
3.Women undergoing planned surgery (including hysterectomy) for endometriosis- and/or fibroid associated symptoms such as abdominal pain, abnormal uterine bleeding, or for unrelated gynaecological conditions (e.g. fertility investigation or for laparoscopic tubal sterilisation).

Exclusion Criteria

The participant may not enter the study if ANY of the following apply:
1.Women who are pregnant.
2.Women who are unable to read, or to understand written or spoken English.
3.History of cancer/ diagnosis of current cancer.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To identify the underlying mechanisms of endometriosis and uterine fibroids and their associated symptoms to improve the outcome of affected women. We will use questionnaire data, medical records and sample analysis to investigate the genetic and molecular basis of the pathogenesis and symptoms of endometriosis and uterine fibroids. The collected data and samples will be analysed and compared between endometriosis/fibroid cases, and non-affected controls. This work will be ongoing during the duration of the study. Samples will be taken after informed consent at the pre-operation appointment, at surgery and at an optionalfollow-up visit. The questionnaires will be completed at baseline, i.e. before surgery, and in intervals afterwards (6 – 8 weeks, 6 months, 12 months and then yearly for 5 years)