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

RecruitingNAAges 18 Years - 38 YearsFemaleKarolinska Institutet
NCT07240363 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Endometriosis surgery
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Where

4 sites
Sodersjukhuset
Stockholm, Sweden
Sahlgrenska University Hospital
Gothenburg, Sweden
Skåne university hospital, Malmö
Malmö, Sweden
Uppsala University Hospital, Uppsala
Uppsala, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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