Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04610710
Other study ID # Horsens MR
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 1, 2020
Est. completion date July 31, 2026

Study information

Verified date March 2023
Source Horsens Hospital
Contact Ulla B Knudsen, Professor
Phone +45 78426592
Email ubk@dadlnet.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Intervention

Procedure:
Operation
Operation for deep infiltrating endometriosis
Fertility treatment
In vitro fertilisation (IVF) and IVF-intracytoplasmic injection (ICSI)

Locations

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

Sponsors (3)

Lead Sponsor Collaborator
Horsens Hospital Aarhus University Hospital, Clinique Tivoli Ducos

Countries where clinical trial is conducted

Denmark,  France, 

Outcome

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
See also
  Status Clinical Trial Phase
Recruiting NCT05969574 - Is Decreased Ovarian Reserve Related to an Increased Number of Previous Early Miscarriages?
Recruiting NCT05358483 - PROspective Study of Mothers' and Infants' Social and Epidemiologic Determinants of Health
Recruiting NCT05969795 - Comparison of Live Birth Rate in Natural Cycle Single Euploid FET Versus Without Luteal Phase Support Phase 1
Recruiting NCT06051201 - Innovation for Small-scale Experiments: ReceptIVFity Test N/A
Completed NCT03177538 - Corifollitropin Alfa Combined With Menotropin Versus Follitropin and Lutropin Alfa in Expected Suboptimal Responders Phase 4
Completed NCT03638856 - Comparing Effectiveness of Oral Misoprostal for Cervical Priming in Hysteroscopy N/A
Completed NCT04052464 - The Study of the Implantation Window From Endometrial Biopsy With Gene Expression Methods
Withdrawn NCT04753736 - Immunophenotypage of RIF and RM Patients and Intrauterine Administration of PBMC N/A
Completed NCT03349905 - Deferred Versus Fresh Embryo Transfers N/A
Completed NCT05076981 - Progesterone Levels During Ovulation and Luteal Phase
Completed NCT04096027 - Cabergoline Before or After Oocyte Collection for Follicular Resolution Phase 4
Recruiting NCT05980091 - Optimal Timing of Euploid Day 6 Blastocyst Transfer in Frozen HRT Cycles, Day 6 or Day 7 of Progesterone Administration. Phase 1
Terminated NCT01933633 - Improved Fertility After Exercise in Overweight/Obese Women N/A
Terminated NCT01202643 - Effect of Colony Stimulating Factor on Poor Endometrial Development During IVF Phase 1/Phase 2
Completed NCT01202656 - Effect of Colony Stimulating Factor on Implantation and Pregnancy Rates Following IVF (in Vitro Fertilization) Phase 1/Phase 2
Completed NCT01408615 - A Post Marketing Observational Study of the Safety and Efficacy of Elonva (Corifollitropin Alfa) in General Practice (P08165)
Enrolling by invitation NCT05698550 - The Role of Erzhi Tiangui Formula in Expected POR Women Undergoing IVF-ET Phase 3
Not yet recruiting NCT03910582 - Personalized FET in RIF Patients With Displaced Dating N/A
Completed NCT05440019 - Evaluation of the Safety and Usability of the M3T Fertigo System and Its Calibration
Completed NCT05130125 - Retrospective Cohort Observational Study to Evaluate the Effectiveness and Safety of Fresh or Frozen Embryo Transfer