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NCT Number: NCT05962775

Ethanol Sclerotherapy Prior to ART

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.

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Key information

Conditions

Endometrioma ART Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female IVF Infertility Sclerotherapy Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Başkent University Adana IVF Center, Adana, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ethanol Sclerotherapy for Endometrioma

Procedure

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.

Primary outcomes

  1. Cumulative live birth rate

    Time frame: 18 months

    live births following fresh and frozen-thaw transfer of all embryos unless pregnancy occurs

Secondary outcomes

  1. pain scores

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sezcan Mumusoglu

CONTACT

[email protected]

+905326404673

Yavuz Emre Sukur

CONTACT

[email protected]

+905332409381

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Collaborators

  • Hacettepe University

Registry information

Official study 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

Acronym: START

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 27, 2023
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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