Actively Recruiting
Led by Karolinska Institutet · Updated on 2025-11-20
350
Participants Needed
4
Research Sites
156 weeks
Total Duration
K
Karolinska Institutet
Lead Sponsor
R
Region Stockholm
Collaborating Sponsor
Endometriosis is a chronic condition affecting about 10% of women of reproductive age, often causing pelvic pain and infertility. Women with advanced endometriosis (stage III-IV) have significantly reduced fertility compared to the general population. This study is the first national multicenter randomized controlled trial comparing surgery followed by IVF with IVF alone to determine which approach better improves pregnancy outcomes in women with advanced endometriosis and infertility. Participants are women under 39 years with stage III-IV endometriosis seeking fertility treatment. They will be randomly assigned to either first undergo laparoscopic surgery to remove endometriosis lesions followed by IVF or to proceed directly to IVF without surgery. Surgery will be performed at specialized centers using laparoscopic techniques, while IVF treatment will involve up to three cycles of controlled ovarian stimulation and embryo transfers according to routine clinical protocols. During the study, participants will undergo ultrasound and possibly MRI to confirm endometriosis staging. Researchers will monitor pregnancy rates, live birth rates within three years, time to pregnancy, treatment complications, and quality of life using questionnaires. Data on healthcare costs and safety outcomes will also be collected. Long-term follow-up at ten years will assess fertility treatments, live births, and repeat surgeries. The total study duration for each participant is three years from first treatment.
CONDITIONS
First Line Surgery or First Line Fertility Treatment Using Assisted Reproductive Technologies in Patients With Advanced Endometriosis
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months from randomization to first treatment, followed by treatment cycles as clinically indicated
Participants receive either first-line surgery followed by assisted reproductive technologies (ART) such as IVF or ICSI, or first-line ART treatment alone with up to three cycles of controlled ovarian stimulation, oocyte retrievals, and embryo transfers according to routine clinical protocols.
Multiple visits including surgery and up to three ART cycles with oocyte retrieval and embryo transfer visits
Duration - Up to 3 years after first treatment
Participants are followed for reproductive outcomes, quality of life, pain assessment, complications, and health economics for up to three years after first treatment.
Scheduled visits before treatment, at oocyte retrieval, 2 months after ART or surgery, and periodic follow-up visits including a 3-year follow-up visit
Total: 4 locations
1
Sodersjukhuset
Stockholm, Stockholm County, Sweden, 11883
Actively Recruiting
2
Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, Sweden
Not Yet Recruiting
3
Skåne university hospital, Malmö
Malmö, Sweden
Not Yet Recruiting
4
Uppsala University Hospital, Uppsala
Uppsala, Sweden
Not Yet Recruiting
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Anna Marklund, Julia Wängberg Nordborg, Christine Asciutto...
https://pubmed.ncbi.nlm.nih.gov/41881534