The long-term impact of endometriosis on reproductive outcomes.
A prospective longitudinal cohort study of the effect of conservative and surgical management for moderate to severe endometriosis on future fertility.
Royal Womens Hospital
700 participants
Nov 1, 2021
Observational
Conditions
Summary
This study is one of nine projects being run as part of a program of endometriosis research recently funded by Medical Research Future Fund Infertility is associated with an increased rate of endometriosis. Surgically treating mild endometriosis has been demonstrated to improve fertility outcomes but studies assessing moderate and severe endometriosis are limited. Even the best studies, however, show that pregnancy rates via natural conception are substantially lower than those seen in fertile women. Laparoscopic surgery to remove endometriosis exposes women to surgical risks including infections, adhesion formation and damage to a major organ. Exposing women to this risk can only be justified if there is a real benefit, either in symptom reduction or with improved fertility. This study will explore the impact of surgical treatment of moderate to severe endometriosis on pregnancy and live birth rates from both natural conception and IVF. In addition, it will seek to clarify whether pre-emptive surgical treatment of endometriosis has an impact on future fertility.
Eligibility
Inclusion Criteria4
- <38 years of age at time of recruitment
- Desire for fertility (current or future)
- Evidence of untreated moderate or severe endometriosis on diagnostic laparoscopy or expert imaging (ultrasound or MRI)
- Own and use a mobile phone
Exclusion Criteria3
- Inability to provide informed consent
- No desire for future fertility
- Findings suspicious of malignancy on imaging
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Interventions
The study intervention/exposure is the surgical management for women with evidence of moderate/severe endometriosis. This study remains an observational study. Participant's management, including the decision to perform surgery, will not be altered by participation in the study. The study aims to observe the impact of surgery vs conservative therapy, but does not dictate the requirement for surgery. Patients will be followed-up monthly from time of recruitment, until first live birth, or for 4 years, whichever occurs first. Operative notes will be reviewed to assess surgical findings and what interventions are performed. Data from investigations and surgeries will be compiled by the research assistant. Patients will be required to complete a baseline questionnaire, then a follow-up monthly (or cyclical questionnaire). The questionnaires are not validated. They have been developed for the purpose of the study. The primary assessable outcome is live-birth, with fertility data obtained along the way. Baseline questionnaire will take 20-30 minutes. Follow-up questionnaires should take less than 10minutes.
Locations(9)
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ACTRN12621000431820