Clinical trial NCT04610710: Impact of Operation on Fertility for Women with Severe Endometriosis
Official title: Comparing Impact of Operation and Fertility Treatment on Fertility for Women with Deep Infiltrating Endometriosis: a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Deep Endometriosis
Infertility, Female
Lead sponsor: Horsens Hospital
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Clinique Tivoli Ducos
First posted: 2020-10-30
Enrollment: 352
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Clinical Trail (RCT)
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Cumulative pregnancy rate (CPR)
timeFrame: 18 months
measure: Live birth rate (LBR)
timeFrame: 18 months
Secondary outcomes:
measure: Non-viable pregnancies
timeFrame: 18 months
measure: Ovarian potential
timeFrame: Baseline and 9-18 months
measure: Time to pregnancy
timeFrame: 18 months
measure: Postoperative complications
timeFrame: 18 months
measure: Fertility treatment complications
timeFrame: 18 months
measure: Pain score
timeFrame: Baseline, 9 and 18 months
measure: Quality of Life (QoL)
timeFrame: Baseline, 9 and 18 months
measure: Delayed bowel function
timeFrame: Baseline, 9 and 18 months
measure: Delayed bladder function
timeFrame: Baseline, 9 and 18 months
measure: Endometriosis hormonal and inflammatory status
timeFrame: Baseline and 9-18 months
measure: Follicles, oocytes, fertilized oocytes, blastocysts, and frozen embryos
timeFrame: 18 months
measure: Blastocyst morphology score
timeFrame: 18 months
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
state: Central Region
city: Horsens
country: Denmark
facility: Horsens Regional Hospital
state: Central region
city: Bordeaux
country: France
facility: The Endometriosis Center, Clinique Tivoli-Ducos
Study officials:
References:
citation: 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.