Infertility Clinical Trial
— STARTOfficial title:
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
NCT number | NCT05962775 |
Other study ID # | AUTF |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2023 |
Est. completion date | April 1, 2025 |
The goal of this randomized controlled trial is to assess the impact of ethanol sclerotherapy on ART cycle outcomes. The main questions it aims to answer are: 1. Does ethanol sclerotherapy before ART cycle has any impact on cumulative live birth rate in patients with endometrioma? 2. Does ethanol sclerotherapy improve chronic pelvic pain, dysmenorrhea, complications during oocyte retrieval, response to ovarian stimulation (number of mature oocytes retrieved), and pregnancy loss rates? Infertile patients with endometrioma between 4-10 cm who are scheduled for ART within 2 cycles will be randomized to ethanol sclerotherapy or no intervention.
Status | Recruiting |
Enrollment | 84 |
Est. completion date | April 1, 2025 |
Est. primary completion date | January 1, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Ankara University School of Medicine, Department of Obstetrics and Gynecology | Ankara |
Lead Sponsor | Collaborator |
---|---|
Ankara University | Hacettepe University |
Turkey,
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Miquel L, Preaubert L, Gnisci A, Netter A, Courbiere B, Agostini A, Pivano A. Transvaginal ethanol sclerotherapy for an endometrioma in 10 steps. Fertil Steril. 2021 Jan;115(1):259-260. doi: 10.1016/j.fertnstert.2020.08.1422. Epub 2020 Oct 8. — View Citation
Miquel L, Preaubert L, Gnisci A, Resseguier N, Pivano A, Perrin J, Courbiere B. Endometrioma ethanol sclerotherapy could increase IVF live birth rate in women with moderate-severe endometriosis. PLoS One. 2020 Sep 28;15(9):e0239846. doi: 10.1371/journal.pone.0239846. eCollection 2020. — View Citation
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Yazbeck C, Koskas M, Cohen Scali S, Kahn V, Luton D, Madelenat P. [How I do... ethanol sclerotherapy for ovarian endometriomas]. Gynecol Obstet Fertil. 2012 Oct;40(10):620-2. doi: 10.1016/j.gyobfe.2012.07.029. Epub 2012 Sep 5. No abstract available. French. — View Citation
Yazbeck C, Madelenat P, Ayel JP, Jacquesson L, Bontoux LM, Solal P, Hazout A. Ethanol sclerotherapy: a treatment option for ovarian endometriomas before ovarian stimulation. Reprod Biomed Online. 2009 Jul;19(1):121-5. doi: 10.1016/s1472-6483(10)60055-7. — View Citation
* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cumulative live birth rate | live births following fresh and frozen-thaw transfer of all embryos unless pregnancy occurs | 18 months | |
Secondary | pain scores | Visual Analog Pain Scale scores related to dysmenorrhea, dyspareunia, and/or pelvic pain will be measured before and after procedure | 3 months |
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