Impact of Operation on Fertility for Women With Severe Endometriosis

Study Overview
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Brief Summary
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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.

Official Title
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Comparing Impact of Operation and Fertility Treatment on Fertility for Women With Deep Infiltrating Endometriosis: A Multicenter Randomized Controlled Trial

Conditions
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Deep Endometriosis, Infertility, Female

Intervention / Treatment
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* Procedure: Operation
* Procedure: Fertility treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Clinical Trail (RCT)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Operation<br>Operation for severe endometriosis | Procedure: Operation<br>* Operation for deep infiltrating endometriosis<br>|
| Active Comparator: Fertility treatment<br>Fertility treatment for women with severe endometriosis. | Procedure: Fertility treatment<br>* In vitro fertilisation (IVF) and IVF-intracytoplasmic injection (ICSI)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative pregnancy rate (CPR) | Rate of cumulative pregnancies defined as a fetal heartbeat by ultrasound at gestational week 6 to 8 | 18 months | 
| Live birth rate (LBR) | Rate of live births | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-viable pregnancies | Number of biochemical pregnancies, miscarriages, missed abortions, extrauterine pregnancies and pregnancies of unknown location (PUL) | 18 months | 
| Ovarian potential | Concentration of Anti-Müllerian hormone (AMH) | Baseline and 9-18 months | 
| Time to pregnancy | Shortest time from intervention date to date of visualisation of the first ongoing pregnancy | 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 | 18 months | 
| Fertility treatment complications | Rate of hospital admissions, bleeding, superinfection, worsening of pain or having ovarian hyperstimulation syndrome (OHSS) | 18 months | 
| Pain score | Numeric Rating Scale (NRS) score from 0 to 10, where 10 implies the worst pain | 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) | Baseline, 9 and 18 months | 
| Delayed bowel function | Development in bowel function rated by Low Anterior Resection Syndrome (LARS) score | Baseline, 9 and 18 months | 
| Delayed bladder function | Development in urinary tract function rated by International Consultation on Incontinence Questionnaire (ICIQ- FLUTS) | Baseline, 9 and 18 months | 
| Endometriosis hormonal and inflammatory status | Concentrations of hormonal and inflammatory markers in blood samples | 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 | 18 months | 
| Blastocyst morphology score | Gardner scoring system, Steer grading system, Veecks criteria, or other scoring systems of blastocyst morphology | 18 months |