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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.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12621000431820
Acronym
ELFS
Enrollment
45
Registered
2021-04-16
Start date
2021-11-01
Completion date
2024-10-31
Last updated
2022-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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

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.

Sponsors

Royal Womens Hospital
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
18 Years to 38 Years
Healthy volunteers
No

Inclusion criteria

• <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 criteria

• Inability to provide informed consent • No desire for future fertility • Findings suspicious of malignancy on imaging

Outcome results

None listed

Source: ANZCTR · Data processed: Aug 22, 2026