TerminatedNot Applicable

Impact of Operation on Fertility for Women With Severe Endometriosis

Stopped: Enrolment of study participants was too challenging and long-drawn.

Denmark, France38 participantsStarted 2020-11-25

Plain-language summary

The EFFORT study compares the impact on fertility of operation or fertility treatment (IVF, in vitro fertilization) in a multicenter randomized controlled trial. The study population consists of women with colorectal deep infiltrating endometriosis and a pregnancy intention. These women will be randomized to either of the two treatment groups: Group A = Operation or Group B = fertility treatment (IVF). Group A will be further divided postoperatively into spontaneous conception or IVF depending on the Endometriosis Fertility Index score.

Who can participate

Age range18 Years – 38 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Cumulative pregnancy rate (CPR)

Timeframe: 18 months

Live birth rate (LBR)

Timeframe: 18 months

Trial details

NCT IDNCT04610710

SponsorHorsens Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-01

View on ClinicalTrials.gov More Deep Endometriosis trials