Impact of Operation on Fertility for Women with Severe Endometriosis

Not Applicable

Recruiting

• Conditions: Infertility, Female; Deep Endometriosis
• Interventions: Procedure: Operation; Procedure: Fertility treatment

• Registration Number: NCT04610710
• Lead Sponsor: Horsens Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-01
• Study First Submitted: 2020-10-22
• Study First Submitted QC: 2020-10-29
• Study First Posted: 2020-10-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13
• Primary Completion: 2030-01-31
• Study Completion: 2035-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 352

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Operation	Operation	Operation for severe endometriosis
Fertility treatment	Fertility treatment	Fertility treatment for women with severe endometriosis.

Primary Outcome Measures

Name	Time	Method
Live birth rate (LBR)	18 months	Rate of live births
Cumulative pregnancy rate (CPR)	18 months	Rate of cumulative pregnancies defined as a fetal heartbeat by ultrasound at gestational week 6 to 8

Secondary Outcome Measures

Name	Time	Method
Quality of Life (QoL)	Baseline, 9 and 18 months	Development in Endometriosis Health Profile (EHP-30+23), including section C (sexual function QoL questions) and section F (fertility QoL questions)
Endometriosis hormonal and inflammatory status	Baseline and 9-18 months	Concentrations of hormonal and inflammatory markers in blood samples
Non-viable pregnancies	18 months	Number of biochemical pregnancies, miscarriages, missed abortions, extrauterine pregnancies and pregnancies of unknown location (PUL)
Fertility treatment complications	18 months	Rate of hospital admissions, bleeding, superinfection, worsening of pain or having ovarian hyperstimulation syndrome (OHSS)
Pain score	Baseline, 9 and 18 months	Numeric Rating Scale (NRS) score from 0 to 10, where 10 implies the worst pain
Delayed bowel function	Baseline, 9 and 18 months	Development in bowel function rated by Low Anterior Resection Syndrome (LARS) score
Blastocyst morphology score	18 months	Gardner scoring system, Steer grading system, Veecks criteria, or other scoring systems of blastocyst morphology
Ovarian potential	Baseline and 9-18 months	Concentration of Anti-Müllerian hormone (AMH)
Time to pregnancy	18 months	Shortest time from intervention date to date of visualisation of the first ongoing pregnancy
Postoperative complications	18 months	Rate of complications in accordance to Clavien-Dindo Classification, including anastomotic leakage or stenosis, ureteral lesion or obstruction, pelvic abscess, fistula, bladder or bowel perforation and urinary retention
Delayed bladder function	Baseline, 9 and 18 months	Development in urinary tract function rated by International Consultation on Incontinence Questionnaire (ICIQ- FLUTS)
Follicles, oocytes, fertilized oocytes, blastocysts, and frozen embryos	18 months	Number of follicles as measured at last scan prior to oocyte pick-up (OPU), number of oocytes at OPU, fertilized oocytes, blastocysts and frozen embryos

Trial Locations

Locations (3)

Aarhus University Hospital; 🇩🇰 Aarhus N, Central Region, Denmark

Horsens Regional Hospital; 🇩🇰 Horsens, Central region, Denmark

The Endometriosis Center, Clinique Tivoli-Ducos; 🇫🇷 Bordeaux, France