Infertility, Female Clinical Trial
— EFFORTOfficial title:
Comparing Impact of Operation and Fertility Treatment on Fertility for Women With Deep Infiltrating Endometriosis: A Multicenter Randomized Controlled Trial
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.
Status | Recruiting |
Enrollment | 352 |
Est. completion date | July 31, 2026 |
Est. primary completion date | January 31, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 38 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Aarhus University Hospital | Aarhus N | Central Region |
Denmark | Horsens Regional Hospital | Horsens | Central Region |
France | The Endometriosis Center, Clinique Tivoli-Ducos | Bordeaux |
Lead Sponsor | Collaborator |
---|---|
Horsens Hospital | Aarhus University Hospital, Clinique Tivoli Ducos |
Denmark, France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cumulative pregnancy rate (CPR) | Rate of cumulative pregnancies defined as a fetal heartbeat by ultrasound at gestational week 6 to 8 | 18 months | |
Primary | Live birth rate (LBR) | Rate of live births | 18 months | |
Secondary | Non-viable pregnancies | Number of biochemical pregnancies, miscarriages, missed abortions, extrauterine pregnancies and pregnancies of unknown location (PUL) | 18 months | |
Secondary | Ovarian potential | Concentration of Anti-Müllerian hormone (AMH) | Baseline and 9-18 months | |
Secondary | Time to pregnancy | Shortest time from intervention date to date of visualisation of the first ongoing pregnancy | 18 months | |
Secondary | 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 | |
Secondary | Fertility treatment complications | Rate of hospital admissions, bleeding, superinfection, worsening of pain or having ovarian hyperstimulation syndrome (OHSS) | 18 months | |
Secondary | Pain score | Numeric Rating Scale (NRS) score from 0 to 10, where 10 implies the worst pain | Baseline, 9 and 18 months | |
Secondary | 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 | |
Secondary | Delayed bowel function | Development in bowel function rated by Low Anterior Resection Syndrome (LARS) score | Baseline, 9 and 18 months | |
Secondary | Delayed bladder function | Development in urinary tract function rated by International Consultation on Incontinence Questionnaire (ICIQ- FLUTS) | Baseline, 9 and 18 months | |
Secondary | Endometriosis hormonal and inflammatory status | Concentrations of hormonal and inflammatory markers in blood samples | Baseline and 9-18 months | |
Secondary | 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 | |
Secondary | Blastocyst morphology score | Gardner scoring system, Steer grading system, Veecks criteria, or other scoring systems of blastocyst morphology | 18 months |
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