NCT03788720Not yet recruiting
Suture of the Ovary After Enucleation of Ovarian Endometrioma
Comparison Between Suture of the Ovary Versus no Suture After Enucleation of Ovarian Endometrioma
Source: ClinicalTrials.gov · Last updated 29 Apr 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Endometriosis is an estrogen-dependent chronic disease, characterized by the presence of ectopic endometrial-like tissue outside the uterine cavity. According to the most updated guidelines of the European Society of Human Reproduction and Embryology (ESHRE), infertile women with endometriomas smaller than 3 cm should be addressed directly to Assisted Reproduction Technology (ART); conversely, for infertile women with endometriomas larger than 3 cm, enucleation of ovarian endometriomas could be considered in order to improve reproductive outcomes (both spontaneous and ART pregnancy rate). To date, literature data do not allow to draw a firm conclusion about the best strategy to reduce ovarian damage during enucleation of ovarian endometriomas: in particular, investigators still lack robust evidence in order to choose between suturing the ovary or not after the enucleation. In this scenario, the aim of our the study will be to compare functional outcomes of the ovary in a group of women undergoing suturing of the ovarian cortex after laparoscopic enucleation of endometriomas (cases) and a group of women undergoing laparoscopic enucleation of endometriomas without subsequent suture of the ovarian cortex.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 11 Oct 2018
- Start date
- May 2023
- Primary completion date
- May 2025
- Lead sponsor
- Università degli Studi dell'Insubria
- Diseases
- Endometriosis
- NCT number
- NCT03788720
What you commit to
- Study type: Interventional
- Planned participants: 100
- From May 2023 to the primary completion date, May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- No previous pelvic surgery (even not gynecological);
- Any other pharmacologic and non pharmacologic treatment in the previous 3 months (wash-out period);
Other illness
- Any other disease;
Other
- Bilateral endometriomas;
- Deep infiltrating endometriosis;
Who the study is looking for
- Women affected by one primary (no recurrent) monolateral ovarian endometrioma, with maximum diameter between 5 and 10 cm, undergoing laparoscopic enucleation by stripping technique;
- Normal AFC at the enrollment (baseline).
Age in the registry: 18 years to 35 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| "Filippo Del Ponte" Hospital Coordinator of this site? Confirm its status | Varese | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.