First Line Surgery or First Line Fertility Treatment Using Assisted Reproductive Technologies in Patients With Advanced Endometriosis

Sponsor
Karolinska Institutet
Study ID
NCT07240363
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 38 Years
Healthy Volunteers
Not accepted

Interventions

  • Endometriosis surgery — PROCEDURE
    Endometriosis surgery followed by ART

Study Details

Endometriosis is a chronic disease affecting approximately 10% of women of reproductive age. It is strongly associated with pelvic pain and infertility. Women with advanced stages of the disease (stage III-IV) have markedly reduced fertility compared with the general population. A Swedish study has shown that about 22% of women undergoing treatments with assisted reproductive technologies (ART), such as in vitro fertilization (IVF), are affected by endometriosis. The optimal management of women with advanced endometriosis and infertility remains uncertain. Some clinicians advocate proceeding directly to IVF, while others suggest surgical removal of endometriosis lesions prior to IVF in order to improve the chances of pregnancy. Currently, evidence is limited to a small number of observational studies. Two observational studies and one meta-analysis have suggested that surgery before IVF in women with deep endometriosis may increase both pregnancy and live birth rates compared with IVF alone. However, no randomized controlled trial (RCT) has yet been conducted to answer this important clinical question. This study will be the first national multicenter randomized controlled trial to compare surgery followed by IVF with IVF alone in women with advanced endometriosis and infertility. All Swedish centers for highly specialized endometriosis surgery and fertility treatment will participate. Eligible participants are women under 39 years of age with stage III-IV endometriosis who seek fertility treatment. Participants will be randomized in a 1:1 ratio to one of two groups: * Surgery prior to IVF (laparoscopic excision of endometriosis lesions, followed by IVF). * Direct IVF without prior surgery. The primary outcome is the cumulative live birth rate within three years of randomization and initiation of the allocated treatment. Secondary outcomes include pregnancy rates, time to pregnancy, treatment-related complications, patient-reported quality of life, and cost-effectiveness. Our hypothesis is that surgery before IVF will lead to a higher cumulative live birth rate compared with IVF without prior surgery in women with advanced endometriosis. The results of this trial are expected to have significant impact on clinical practice and international guidelines. Regardless of outcome, the study will provide robust evidence to guide treatment strategies, improve the care of women with advanced endometriosis and infertility, and potentially reduce healthcare costs by identifying the most effective pathway to achieving pregnancy.

Key Dates

First listed
Nov 20, 2025
Start date
Oct 6, 2025
Status verified
Nov 2025
Primary completion
Sep 22, 2028
Completion
Sep 22, 2031

Study Design

Enrollment
350 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: First-line ART
    Women allocated in the ART arm will undergo up to three cycles of controlled ovarian stimulation (COS) followed by oocyte retrievals and embryo transfers. In Sweden, ART-treatment costs for women under the age of forty and without having children in current relationship are covered by the tax-funded healthcare system, with up to 3 IVF/ICSI treatments, given that they are considered medically meaningful, and that each stimulation is started before the woman turns 40 years of age (39). In case the treatment results in cryopreserved embryos, it is planned that they should be transferred prior to the start of any new COS. Women will be managed according to a routine clinical protocol at each reproductive unit. Stimulation protocols will be chosen individually by clinicians, taking into consideration age and ovarian reserve of each woman, as it is a standard routine in the collaborating Reproductive Units.
  • Experimental: First-line surgery followed by ART
    Surgery will be performed at one of four nationally specialized centers in advanced endometriosis surgery (Södersjukhuset Stockholm, Sahlgrenska University Hospital Göteborg, Skånes University Hospital, Malmö/Lund, Uppsala University Hospital). Surgery will be conducted according to the ESHRE recommendations of surgery in endometriomas and deep endometriosis (32, 33). Surgery should be multidisciplinary when needed (colorectal surgeons and urologists). The goal of the procedure is to remove as many endometriotic lesions as possible while also minimizing negative impact on organ function, since endometriosis is a benign disease. Rectal endometriosis will be removed with rectal shaving, discoid or segmental resection depending on the size and placement of the lesion in the rectal wall. Laparoscopic cyst enucleation is considered the "golden standard". In cases where ovarian reserve is already diminished, more gentle ablation methods could be employed

Primary Outcome Measure

Cumulative live-birth rate (CLBR) [ Time Frame: Three years from first treatment (surgery or ART treatment) ]

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