Surgery first versus IVF-first for people with advanced endometriosis
First Line Surgery or First Line Fertility Treatment Using Assisted Reproductive Technologies in Patients With Advanced Endometriosis: A National Multicenter Randomized-controlled Trial
NA · Karolinska Institutet · NCT07240363
This trial will test whether having surgery before assisted reproductive technologies (like IVF) or going straight to IVF gives people with advanced endometriosis a better chance of pregnancy and live birth.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 18 Years to 38 Years |
| Sex | Female |
| Sponsor | Karolinska Institutet (other) |
| Locations | 4 sites (Stockholm, Stockholm County and 3 other locations) |
| Trial ID | NCT07240363 on ClinicalTrials.gov |
What this trial studies
This interventional trial compares two first-line approaches for people with advanced (AAGL stage III–IV) endometriosis who want fertility treatment: surgical removal of endometriosis lesions prior to assisted reproductive technologies (ART) versus proceeding directly to ART (for example IVF/ICSI). Eligible participants (age 18–38, BMI 18–35, no prior endometriosis surgery beyond diagnostic laparoscopy, and no prior IVF/ICSI cycles) will be assigned to either surgery followed by ART or to immediate ART and followed for pregnancy and live birth outcomes. Major exclusions include hydrosalpinx, clear indications for immediate surgery, suspected malignancy, large or certain fibroids, and uterine malformations. The study will use reproductive outcomes such as clinical pregnancy and live birth rates to determine whether pre-ART surgery improves chances of having a child compared with ART alone.
Who should consider this trial
Good fit: Ideal candidates are people aged 18–38 with AAGL stage III–IV endometriosis, BMI 18–35, referred or eligible for ART, who have not had prior endometriosis surgery beyond diagnostic laparoscopy or prior IVF/ICSI and who can give informed consent.
Not a fit: Patients with prior endometriosis surgery or prior IVF, hydrosalpinx, clear urgent surgical indications, suspected malignancy, large fibroids, or significant uterine malformations are unlikely to benefit or are ineligible for this comparison.
Why it matters
Potential benefit: If successful, the trial could clarify whether surgery before ART increases pregnancy and live birth rates and thus guide the best first-line approach for people with advanced endometriosis and infertility.
How similar studies have performed: A small number of observational studies and one meta-analysis have suggested that surgery before IVF may improve pregnancy and live birth rates, but randomized evidence is limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Stockholm, Stockholm County and 3 other locations
- Sodersjukhuset — Stockholm, Stockholm County, Sweden (RECRUITING)
- Sahlgrenska University Hospital — Gothenburg, Västra Götaland County, Sweden (NOT_YET_RECRUITING)
- Skåne university hospital, Malmö — Malmö, Sweden (NOT_YET_RECRUITING)
- Uppsala University Hospital, Uppsala — Uppsala, Sweden (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Malin Brunes, MD, PhD — Karolinska Institutet
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Endometriosis, Infertility Assisted Reproductive Technology, Infertility, Surgery, ART