RecruitingACTRN12621000431820

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.


Sponsor

Royal Womens Hospital

Enrollment

700 participants

Start Date

Nov 1, 2021

Study Type

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

Sex: FemalesMin Age: 18 YearssMax Age: 38 Yearss

Plain Language Summary

Simplified for easier understanding

Endometriosis is a condition where tissue similar to the lining of the uterus grows outside the womb, causing pain and, in many cases, difficulties getting pregnant. Surgery to remove endometriosis can relieve symptoms, but the evidence for whether it also improves fertility — particularly for moderate to severe disease — is limited. This study follows women with moderate or severe endometriosis over time to understand the impact of surgical treatment on their chances of pregnancy and live birth. You may be eligible if you are under 38 years old, want to have children now or in the future, and have been diagnosed with moderate or severe endometriosis on laparoscopy or imaging (ultrasound or MRI). You will need to own and use a mobile phone. Participants will be tracked over several years and asked about their fertility outcomes — whether they became pregnant naturally, through IVF, or not at all. This is an observational study, meaning the researchers will not tell you which treatment to have; they simply follow what happens. The data will help clarify whether operating on endometriosis before attempting pregnancy is genuinely beneficial, helping women and their doctors make better-informed decisions.

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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 t

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)

The Royal Women's Hospital - Parkville

VIC, Australia

Mercy Hospital for Women - Heidelberg

VIC, Australia

Sunshine Hospital - St Albans

VIC, Australia

Epworth Richmond - Richmond

VIC, Australia

Epworth Freemasons (Clarendon Street) - East Melbourne

VIC, Australia

Frances Perry House - Parkville

VIC, Australia

Warringal Private Hospital - Heidelberg

VIC, Australia

East Melbourne Specialist Day Hospital - East Melbourne

VIC, Australia

Jerusalem, Israel

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ACTRN12621000431820


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