ART, Endometrioma, Infertility, IVF, Sclerotherapy
Conditions
Keywords
endometrioma, ethanol sclerotherapy, assisted reproductive technology, in vitro fertilization, cumulative live birth rate
Brief summary
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.
Detailed description
The effect of ethanol sclerotherapy before assisted reproductive technology (ART) cycle in patients with endometrioma on reproductive outcomes will be investigated. While endometrioma may result in technical difficulties in the ART process, the superiority of ethanol sclerotherapy has yet to be examined before the ART procedure in randomized controlled studies and meta-analyses. The negative effect of ethanol sclerotherapy on ovarian reserve was found to be less than other existing interventions such as cyst stripping. However, randomized controlled studies did not determine its direct effect on ART outcome. Our current study aimed to assess the effect of ethanol sclerotherapy on ART outcomes. Infertile patients aged 18-40 years with at least one endometrioma 4-10 cm and scheduled for ART will be included in the study. Patients with any untreated thyroid dysfunction or additional disease, such as hyperprolactinemia, those who did not accept the study information and consent, and patients younger than 18 or older than 40 will not be included. Those who underwent surgery for endometrioma within 3 months before ART will be excluded. In addition, patients with an anti-mullerian hormone value below 0.3 ng/ml will not be included in the study.
Interventions
PROCEDUREEthanol Sclerotherapy for Endometrioma
2 gr IV cefazolin sodium will be administered 30 minutes before the procedure. The endometrioma cyst content will be aspirated by a single lumen needle, and the total aspirated volume calculation will be done. The endometrioma will then be washed with saline until the color of the cyst content becomes clear. Then, 96% ethanol will be injected into the cyst. The volume of injected ethanol will be 60% of the first aspirated volume (maximum 100 ml). After 10 minutes all ethanol will be aspirated.
Sponsors
Hacettepe University
Ankara University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative live birth rate | 18 months | live births following fresh and frozen-thaw transfer of all embryos unless pregnancy occurs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pain scores | 3 months | Visual Analog Pain Scale scores related to dysmenorrhea, dyspareunia, and/or pelvic pain will be measured before and after procedure. 0 is the lowest, 10 is the highest score. Higher the score means higher the pain. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactYavuz Emre Sukur
Backup ContactSezcan Mumusoglu
Outcome results
None listed