Impact of Operation on Fertility for Women With Severe Endometriosis

Infertility, Female Clinical Trial

— EFFORT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04610710
• Other study ID #: Horsens MR
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Deep Endometriosis
• Endometriosis
• Infertility
• Infertility, Female

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