GnRH-a on Angiogenesis of Endometriosis

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06106932
Study type	Interventional
Source	University of Patras
Contact
Status	Completed
Phase	N/A
Start date	September 2015
Completion date	January 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01931670` - A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain	Phase 3
Recruiting	`NCT05648669` - A Study to Evaluate Safety and Efficacy of Elagolix in Patients With Moderate to Severe Endometriosis-Associated Pain	Phase 3
Completed	`NCT04081532` - The Effectiveness of Laparoscopic Treatment of Superficial Endometriosis for Managing Chronic Pelvic Pain	N/A
Recruiting	`NCT06101303` - Endometriosis Pain
Completed	`NCT04665414` - Diagnosis of Adenomyosis Using Ultrasound, Elastography and MRI
Completed	`NCT03690765` - Study of Real Clinical Practice to Evaluate the Effects of Oral Dydrogesterone for Treatment of Confirmed Endometriosis
Recruiting	`NCT05153512` - ADOlescent DysmenoRrhea Endometriosis Assessment Magnetic Resonance Imaging (Adodream)
Active, not recruiting	`NCT04171297` - Ultrasound Evaluation of the Pelvis in Women With Suspected Endometriosis Scheduled for Laparoscopic Surgery
Recruiting	`NCT04172272` - The Influence of TAP Block in the Control of Postoperative Pain After Laparotomy for Gynecological Procedures	N/A
Completed	`NCT04565470` - Strategies of Self-management of Endometriosis Symptoms
Completed	`NCT03613298` - Treatment by HIFU With Focal One® of Posterior Deep Infiltrating Endometriosis Lesions With Intestinal Involvement.	N/A
Withdrawn	`NCT05568940` - Evaluating Tibolone Add-back in Patients With Endometriosis and Fibroids
Not yet recruiting	`NCT03464799` - Does Immunotherapy Have a Role in the Management of Endometriosis?
Active, not recruiting	`NCT03002870` - Characteristics of Patient Population With Endometriosis	N/A
Completed	`NCT02973854` - Activation of the Sphingosine-1-phosphate (S1P) to S1P1 Receptor Subtype (S1PR1) Axis in Patients With Endometriosis: Identification of Potential Relevant Biomarkers to Diagnose and Treat
Withdrawn	`NCT03272360` - Endometriosis Biomarker Discovery Study	N/A
Recruiting	`NCT02481739` - Laparoscopic Surgical Management of Endometriosis on Fertility	N/A
Active, not recruiting	`NCT02754648` - Three Different Laparoscopic Approaches for Ovarian Endometrioma and the Effect on Ovarian Reserve	N/A
Completed	`NCT02387931` - Supplementation in Adolescent Girls With Endometriosis	Phase 4
Completed	`NCT02098668` - Mathematical Model for the Human Menstrual Cycle, Endocrinological Diseases and Fertility Treatment-PAEON	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.