Comparing surgery and IVF for women with severe endometriosis and infertility
Comparing Impact of Operation and Fertility Treatment on Fertility for Women with Deep Infiltrating Endometriosis: a Multicenter Randomized Controlled Trial
This study is testing whether surgery or IVF works better to help women with severe endometriosis get pregnant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 352 (estimated) |
| Ages | 18 Years to 38 Years |
| Sex | Female |
| Sponsor | Horsens Hospital Academic / other |
| Locations | 3 sites (Aarhus N, Central Region and 2 other locations) |
| Trial ID | NCT04610710 on ClinicalTrials.gov |
What this trial studies
The EFFORT study investigates the effects of surgical intervention versus fertility treatment (IVF) on the fertility outcomes of women suffering from colorectal deep infiltrating endometriosis who wish to conceive. Participants will be randomly assigned to either undergo surgery or receive IVF treatment, with further categorization based on their postoperative fertility potential. This multicenter randomized controlled trial aims to provide insights into the most effective approach for improving fertility in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are women with colorectal deep infiltrating endometriosis who have been trying to conceive for at least six months and meet specific health criteria.
Not a fit: Patients with severe endometriosis affecting the ureters or those with contraindications for IVF may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help determine the best treatment option for women with severe endometriosis seeking to conceive.
How similar studies have performed: Other studies have explored similar interventions, but the specific comparison of surgery versus IVF in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Rectosigmoid endometriosis and wish for surgery * Pregnancy intention for at least 6 months * AMH above 5 pmol/ml * Maximum of 2 previous IVF treatments * Male partner Exclusion Criteria: * Endometriosis involving the ureter unilaterally or bilaterally (randomization unethical) * BMI above 32 * Contraindication for IVF (untreated uterine factor infertility, untreated/maltreated systemic or malignant disease, oocyte aspiration severely riskful (e.g. severe abdominal adhesions) * No wish for randomization
Where this trial is running
Aarhus N, Central Region and 2 other locations
- Aarhus University Hospital — Aarhus N, Central Region, Denmark (Recruiting)
- Horsens Regional Hospital — Horsens, Central region, Denmark (Recruiting)
- The Endometriosis Center, Clinique Tivoli-Ducos — Bordeaux, France (Recruiting)
Study contacts
- Study coordinator: Ulla B Knudsen, Professor
- Email: ubk@dadlnet.dk
- Phone: +45 78426592
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.