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Enrolment of study participants was too challenging and long-drawn.
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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
| Clinique Tivoli Ducos | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Operation | Active Comparator | Operation for severe endometriosis |
|
| Fertility treatment | Active Comparator | Fertility treatment for women with severe endometriosis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Operation | Procedure | Operation for deep infiltrating endometriosis |
| |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus N | Central Region | 8200 | Denmark | ||
| Horsens Regional Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35410921 | Derived | Raos M, Roman H, Seyer-Hansen M, Kesmodel US, Knudsen UB. EFFORT study: Comparing impact of operation and assisted reproductive technologies on fertility for women with deep infiltrating endometriosis - study protocol for a multicentre randomised trial. BMJ Open. 2022 Apr 11;12(4):e052877. doi: 10.1136/bmjopen-2021-052877. |
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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Randomized Clinical Trail (RCT)
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| Fertility treatment |
| Procedure |
In vitro fertilisation (IVF) and IVF-intracytoplasmic injection (ICSI) |
|
| 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 |
| Horsens |
| Central Region |
| 8700 |
| Denmark |
| The Endometriosis Center, Clinique Tivoli-Ducos | Bordeaux | France |
| D000091662 | Genital Diseases |
| D007246 | Infertility |