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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Operation for deep infiltrating endometriosis
In vitro fertilisation (IVF) and IVF-intracytoplasmic injection (ICSI)
Aarhus University Hospital
Aarhus N, Central Region, Denmark
Horsens Regional Hospital
Horsens, Central Region, Denmark
The Endometriosis Center, Clinique Tivoli-Ducos
Bordeaux, France
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
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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