NCT07240363 First Line Surgery or First Line Fertility Treatment Using Assisted Reproductive Technologies in Patients With Advanced Endometriosis
| NCT ID | NCT07240363 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska Institutet |
| Condition | Endometriosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 350 participants |
| Start Date | 2025-10-06 |
| Primary Completion | 2028-09-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 350 participants in total. It began in 2025-10-06 with a primary completion date of 2028-09-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Age 18 - 38 years old * Endometriosis AAGL stage III-IV * Referred or eligible for ART-treatment such as IVF or ICSI, independent of infertility diagnosis (28) (including sperm donation cycles for social reasons) and/or infertility due to dyspareunia/dysmenorrhea caused by endometriosis * Body mass index 18-35 kg/m2 * Patients who have signed an approved Informed Consent Exclusion Criteria: * Previous surgery for endometriosis except diagnostic laparoscopy. * Previous IVF/ICSI-cycles (including prior fertility preservation cycles) * Hemato- and/or hydrosalpinx * Clear indication for surgery such as ureteral stenosis or intestinal sub-occlusive symptoms * Suspicion of malignancy * Submucosal fibroids (The International Federation of Gynecology and Obstetrics (FIGO) 0-1, any size) or intramural fibroids (FIGO 2-5, \> 4 cm largest diameter of the largest myoma) (29) * Uterine malformations (class U1-U6 according to ESHRE/ESGE-classification) (30) * Patients with contraindications to surgery * Patients undergoing ART with donated oocytes
Contact & Investigator
Malin Brunes, MD, PhD
PRINCIPAL INVESTIGATOR
Karolinska Institutet
Frequently Asked Questions
Who can join the NCT07240363 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 38 Years, studying Endometriosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07240363 currently recruiting?
Yes, NCT07240363 is actively recruiting participants. Visit ClinicalTrials.gov or contact Karolinska Institutet to inquire about joining.
Where is the NCT07240363 trial being conducted?
This trial is being conducted at Stockholm, Sweden, Gothenburg, Sweden, Malmö, Sweden, Uppsala, Sweden.
Who is sponsoring the NCT07240363 clinical trial?
NCT07240363 is sponsored by Karolinska Institutet. The principal investigator is Malin Brunes, MD, PhD at Karolinska Institutet. The trial plans to enroll 350 participants.