Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05962775
Status:
RECRUITING
Last Update Posted:
2023-07-27
First Post:
2023-07-19
Brief Title:
Ethanol Sclerotherapy Prior to ART
Sponsor:
Ankara University
Organization:
Ankara University
Study Overview
Official 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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
START
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
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 03 ngml will not be included in the study
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 03 ngml will not be included in the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None