Deep Endometriosis, Infertility, Female
Conditions
Brief summary
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.
Interventions
PROCEDUREOperation
Operation for deep infiltrating endometriosis
PROCEDUREFertility treatment
In vitro fertilisation (IVF) and IVF-intracytoplasmic injection (ICSI)
Sponsors
Horsens Hospital
Aarhus University Hospital
Clinique Tivoli Ducos
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized Clinical Trail (RCT)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 38 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative pregnancy rate (CPR) | 18 months | Rate of cumulative pregnancies defined as a fetal heartbeat by ultrasound at gestational week 6 to 8 |
| Live birth rate (LBR) | 18 months | Rate of live births |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Non-viable pregnancies | 18 months | Number of biochemical pregnancies, miscarriages, missed abortions, extrauterine pregnancies and pregnancies of unknown location (PUL) |
| Ovarian potential | Baseline and 9-18 months | Concentration of Anti-Müllerian hormone (AMH) |
| Time to pregnancy | 18 months | Shortest time from intervention date to date of visualisation of the first ongoing pregnancy |
| Postoperative complications | 18 months | 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 |
| Fertility treatment complications | 18 months | Rate of hospital admissions, bleeding, superinfection, worsening of pain or having ovarian hyperstimulation syndrome (OHSS) |
| Pain score | Baseline, 9 and 18 months | Numeric Rating Scale (NRS) score from 0 to 10, where 10 implies the worst pain |
| Quality of Life (QoL) | Baseline, 9 and 18 months | Development in Endometriosis Health Profile (EHP-30+23), including section C (sexual function QoL questions) and section F (fertility QoL questions) |
| Delayed bowel function | Baseline, 9 and 18 months | Development in bowel function rated by Low Anterior Resection Syndrome (LARS) score |
| Delayed bladder function | Baseline, 9 and 18 months | Development in urinary tract function rated by International Consultation on Incontinence Questionnaire (ICIQ- FLUTS) |
| Endometriosis hormonal and inflammatory status | Baseline and 9-18 months | Concentrations of hormonal and inflammatory markers in blood samples |
| Follicles, oocytes, fertilized oocytes, blastocysts, and frozen embryos | 18 months | 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 |
| Blastocyst morphology score | 18 months | Gardner scoring system, Steer grading system, Veecks criteria, or other scoring systems of blastocyst morphology |
Countries
Denmark, France
Outcome results
None listed