An interventional study of Operation and Fertility treatment in Deep Endometriosis and Infertility, Female, sponsored by Horsens Hospital. Terminated at 3 sites in 2 countries. Open to female participants aged 18 Years to 38 Years. Per ClinicalTrials.gov, last updated 2026-03-10.
Sponsored by Horsens Hospital · Not applicable, Interventional, and Treatment
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.
540 studies on the registry are indexed under Infertility, Female; 138 are open to participants now.
This study's enrollment of 38 is below the median of 100 across 371 interventional studies indexed under Infertility, Female.
Browse Infertility, Female studies →Horsens Hospital is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Operation for severe endometriosis
Procedure: Operation
Fertility treatment for women with severe endometriosis.
Procedure: Fertility treatment
Operation for deep infiltrating endometriosis
In vitro fertilisation (IVF) and IVF-intracytoplasmic injection (ICSI)
Cumulative pregnancy rate (CPR)
Rate of cumulative pregnancies defined as a fetal heartbeat by ultrasound at gestational week 6 to 8
Time frame: 18 months
Live birth rate (LBR)
Rate of live births
Time frame: 18 months
Non-viable pregnancies
Number of biochemical pregnancies, miscarriages, missed abortions, extrauterine pregnancies and pregnancies of unknown location (PUL)
Time frame: 18 months
Ovarian potential
Concentration of Anti-Müllerian hormone (AMH)
Time frame: Baseline and 9-18 months
Time to pregnancy
Shortest time from intervention date to date of visualisation of the first ongoing pregnancy
Time frame: 18 months
Postoperative complications
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
Time frame: 18 months
Fertility treatment complications
Rate of hospital admissions, bleeding, superinfection, worsening of pain or having ovarian hyperstimulation syndrome (OHSS)
Time frame: 18 months
Pain score
Numeric Rating Scale (NRS) score from 0 to 10, where 10 implies the worst pain
Time frame: Baseline, 9 and 18 months
Quality of Life (QoL)
Development in Endometriosis Health Profile (EHP-30+23), including section C (sexual function QoL questions) and section F (fertility QoL questions)
Time frame: Baseline, 9 and 18 months
Delayed bowel function
Development in bowel function rated by Low Anterior Resection Syndrome (LARS) score
Time frame: Baseline, 9 and 18 months
Delayed bladder function
Development in urinary tract function rated by International Consultation on Incontinence Questionnaire (ICIQ- FLUTS)
Time frame: Baseline, 9 and 18 months
Endometriosis hormonal and inflammatory status
Concentrations of hormonal and inflammatory markers in blood samples
Time frame: Baseline and 9-18 months
Follicles, oocytes, fertilized oocytes, blastocysts, and frozen embryos
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
Time frame: 18 months
Blastocyst morphology score
Gardner scoring system, Steer grading system, Veecks criteria, or other scoring systems of blastocyst morphology
Time frame: 18 months
Plan to share: No
This study is terminated, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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