Surgery first versus IVF-first for people with advanced endometriosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.