Ethanol treatment before assisted reproductive technology for endometrioma
The Impact of Ethanol Sclerotherapy Before ART (Assisted Reproductive Technology) Cycle on Cumulative Live Birth Rate in Infertile Women With Endometrioma: A Randomized Controlled Trial
This study is testing if a treatment using ethanol can help women with endometriomas have better success with fertility treatments and reduce pain before they try to get pregnant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Ankara University Academic / other |
| Locations | 3 sites (Adana and 2 other locations) |
| Trial ID | NCT05962775 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of ethanol sclerotherapy on the outcomes of assisted reproductive technology (ART) in patients with endometriomas measuring 4-10 cm. Participants will be randomly assigned to receive either ethanol sclerotherapy or no intervention prior to their ART cycles. The study aims to determine if this treatment improves cumulative live birth rates, reduces chronic pelvic pain, and enhances ovarian response during ART. The trial will include infertile women aged 18-40 with specific eligibility criteria, ensuring a focused assessment of the intervention's efficacy.
Who should consider this trial
Good fit: Ideal candidates are infertile women aged 18-40 with unilateral or bilateral endometriomas between 4-10 cm.
Not a fit: Patients with untreated thyroid dysfunction, other significant health issues, or those who have undergone recent surgery for endometrioma may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve reproductive outcomes for patients with endometriomas undergoing ART.
How similar studies have performed: While the use of ethanol sclerotherapy has shown promise in other contexts, this specific application prior to ART is novel and has not been extensively tested in randomized controlled studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * AMH\>0.3 ng/ml * unilateral/bilateral endometrioma * Endometrioma diameter 40-100 mm Exclusion Criteria: * 3 or more IVF/embryo transfer failure * Menstrual cycle abnormalities * Male Factor infertility * Presence of uterine fibroids * Presence of hydrosalpinx * Presence of uterine abnormalities * Suspicion of malignancy according to International Ovarian Tumor Analysis criteria
Where this trial is running
Adana and 2 other locations
- Başkent University Adana IVF Center — Adana, Turkey (Türkiye) (Recruiting)
- Ankara University School of Medicine, Department of Obstetrics and Gynecology — Ankara, Turkey (Türkiye) (Recruiting)
- Bahçeci IVF Clinic — Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Batuhan Aslan — Ankara University
- Study coordinator: Yavuz Emre Sukur
- Email: yesukur@gmail.com
- Phone: +905332409381
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.