Actively Recruiting

Phase Not Applicable
Age: 18Years - 40Years
FEMALE
Healthy Volunteers
ID05962775

The Impact of Ethanol Sclerotherapy Before ART Cycle on Cumulative Live Birth Rate in Infertile Women With Endometrioma

Led by Ankara University · Updated on 2024-10-16

84

Participants Needed

3

Research Sites

12 weeks

Total Duration

On this page

Sponsors

A

Ankara University

Lead Sponsor

H

Hacettepe University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating the effects of ethanol sclerotherapy before assisted reproductive technology (ART) cycles in infertile women with endometrioma. This randomized controlled trial aims to determine whether ethanol sclerotherapy impacts the cumulative live birth rate and other outcomes such as chronic pelvic pain, dysmenorrhea, complications during egg retrieval, response to ovarian stimulation, and pregnancy loss rates. The study focuses on patients with endometrioma sized 4 to 10 cm who are scheduled to undergo ART within two cycles. Participants will be randomly assigned to one of two groups. In the control group, patients will proceed to ART without any intervention before the cycle. In the treatment group, ethanol sclerotherapy will be performed 1 to 2 cycles before ART. This procedure involves aspirating the endometrioma cyst content, washing it with saline, injecting 96% ethanol for 10 minutes, and then aspirating the ethanol. Antibiotics will be given before the procedure to reduce infection risk. Throughout the study, participants will be monitored for outcomes such as the cumulative live birth rate over 18 months and pain scores over 3 months. Assessments include tracking the number of mature eggs retrieved, complications during procedures, and pregnancy loss rates. The study will also consider factors like ovarian reserve measured by anti-Mullerian hormone levels. Participant involvement includes treatment procedures, ART cycles, and follow-up for outcome measurements and safety monitoring.

CONDITIONS

Brief Title

Ethanol Sclerotherapy Prior to ART

Who Can Participate

Age: 18Years - 40Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Anti-Mullerian hormone (AMH) level greater than 0.3 ng/ml
  • Presence of unilateral or bilateral endometrioma
  • Endometrioma diameter between 40 mm and 100 mm
  • Female aged between 18 and 40 years
  • Scheduled for assisted reproductive technology (ART) cycle within 1-2 cycles
Not Eligible

You will not qualify if you...

  • Three or more failed IVF or embryo transfer attempts
  • Irregular menstrual cycles or menstrual 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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Ethanol Sclerotherapy

Duration - Up to 2 ART cycles before treatment

Participants in the study group receive ethanol sclerotherapy to treat endometrioma 1-2 cycles before starting the assisted reproductive technology (ART) cycle. This involves aspirating the cyst content and injecting ethanol to treat the cyst.

1 to 2 procedure visits

ART Cycle

Duration - 1 to 2 ART cycles

Participants undergo assisted reproductive technology (ART) cycles following ethanol sclerotherapy or without intervention in the control group.

Visits as part of ART treatment

Follow-up

Duration - Up to 18 months after ART cycles

Participants are followed for reproductive outcomes including live birth rate and pain scores after ART cycles.

Visits for outcome assessments up to 18 months

Trial Site Locations

Total: 3 locations

1

Başkent University Adana IVF Center

Adana, Turkey (Türkiye)

Actively Recruiting

2

Ankara University School of Medicine, Department of Obstetrics and Gynecology

Ankara, Turkey (Türkiye), 06610

Actively Recruiting

3

Bahçeci IVF Clinic

Istanbul, Turkey (Türkiye)

Actively Recruiting

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Research Team

Y

Yavuz Emre Sukur

S

Sezcan Mumusoglu

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

A comparison of follicular response of ovaries to ovulation induction after laparoscopic ovarian cystectomy or fenestration and coagulation versus normal ovaries in patients with endometrioma.

Saeed Alborzi, Romina Ravanbakhsh, Mohammad E Parsanezhad...

https://pubmed.ncbi.nlm.nih.gov/17433319

Reproductive, obstetric, and perinatal outcomes of women with adenomyosis and endometriosis: a systematic review and meta-analysis.

Joanne Horton, Monique Sterrenburg, Simon Lane...

https://pubmed.ncbi.nlm.nih.gov/31318420