Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-01-05 @ 2:08 AM
Study NCT ID:
NCT06106932
Status:
COMPLETED
Last Update Posted:
2023-10-30
First Post:
2023-10-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GnRH-a on Angiogenesis of Endometriosis
Sponsor:
University of Patras
Organization:
Study Overview
Official Title:
The Effects of GnRH-a on Angiogenesis of Endometriosis
Status:
COMPLETED
Status Verified Date:
2023-10
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:
None
Brief Summary:
Purpose: Neo-angiogenesis is necessary for adhesion and invasiveness of endometriotic lesions in women affected by endometriosis. VEGF is one of the major components of angiogenesis and is part of the major pathway TF-PAR-2-VEGF that leads to neo-angiogenesis. SP1 is a transcriptional factor that has lately been studied for its crucial role in angiogenesis, via a distinct pathway. We hypothesize that by blocking angiogenetic pathways we can repress endometriotic lesions. GnRH-agonists are routinely used, especially pre-operatively, in endometriosis. It would be interesting to clarify which angiogenetic pathways are affected and pave the way for further research over anti-angiogenetic effects on endometriosis.
Methods: We used qRT-PCR to study mRNA expression levels of TF, PAR-2, VEGF and SP1 in endometriotic tissues of women who underwent surgery for endometriosis and received GnRH-a \[leuprolide acetate\] preoperatively.
Methods: We used qRT-PCR to study mRNA expression levels of TF, PAR-2, VEGF and SP1 in endometriotic tissues of women who underwent surgery for endometriosis and received GnRH-a \[leuprolide acetate\] preoperatively.
Detailed Description:
The subjects in this study were women of reproductive age. From September 2015 to December 2022, sixty women with known endometriosis \[stage 2 and 3\], were recruited. Their mean age was 38 years. They were nulliparous and had a mean BMI of 27 kg/m2. The ovarian endometrioma, present in all the participants, was diagnosed by ultrasonography and/or magnetic resonance imaging.
This was a prospective randomized follow up study with analysis of ovarian samples derived from GnRH agonists-treated and non-treated women before surgery. The randomization was performed by accessing a central internet-based randomization program. The random allocation sequence and the assignment of the participants to interventions were made by 2 of the authors \[A.K. and S.K\].
After enrollment, patients were divided into 2 groups . During laparoscopy, biopsy specimens of the ovarian endometrioma were collected. The staging of endometriosis was based on the rASRM classification system. In group B, surgery was performed during the proliferative phase of the menstrual cycle. All biopsy specimens were collected in accordance with the guidelines of the Declaration of Helsinki and with the approval of the ethical committee of the General University Hospital of Patras. Informed consent was obtained from all women.
This was a prospective randomized follow up study with analysis of ovarian samples derived from GnRH agonists-treated and non-treated women before surgery. The randomization was performed by accessing a central internet-based randomization program. The random allocation sequence and the assignment of the participants to interventions were made by 2 of the authors \[A.K. and S.K\].
After enrollment, patients were divided into 2 groups . During laparoscopy, biopsy specimens of the ovarian endometrioma were collected. The staging of endometriosis was based on the rASRM classification system. In group B, surgery was performed during the proliferative phase of the menstrual cycle. All biopsy specimens were collected in accordance with the guidelines of the Declaration of Helsinki and with the approval of the ethical committee of the General University Hospital of Patras. Informed consent was obtained from all women.
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: