NCT03717870Not yet recruiting
Surgery and ART For Endometrioma
Evaluation of Reproductive Outcomes After Different Management of Ovarian Endometrioma Prior to Assisted Reproduction Technology (ART): Laparoscopic Enucleation Vs Prolonged Pituitary Downregulation With Gonadotropin Releasing Hormone (GnRH)-Agonists
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 endometrial-like tissue, glands and stroma outside the uterine cavity. Although endometriosis is classified in four stage (minimal, mild, moderate, severe), from the clinical point of view it is possible to subdivide among peritoneal superficial lesions, ovarian endometriomas and Deep Infiltrating Endometriosis (DIE). According to the European Society for Human Reproduction and Embryology (ESHRE) Guideline on the management of women with endometriosis, it is recommended to clinicians that in infertile women with endometrioma larger than 3 cm, cystectomy should be considered prior to Assisted Reproduction Technology (ART) to improve endometriosis-associated pain or the accessibility of follicles. They further recommend that clinicians counsel women with endometrioma regarding the risks of reduced ovarian function after surgery, the possible loss of the ovary, and consider that the decision to proceed with surgery should be taken carefully if the woman has had previous ovarian surgery. In addition, this Guideline suggests that clinicians can prescribe prolonged (3-6 months) pituitary downregulation with Gonadotropin Releasing Hormone-agonists (GnRH-a) prior to ART, in order to increase live birth rate by four-fold. Despite these recommendations, to date there is not robust evidence to choose between the two strategies prior to ART in order to improve reproductive outcomes. For this reason, the aim of the current study will be to compare reproductive outcomes in infertile women affected by ovarian endometrioma, undergoing laparoscopic enucleation or prolonged pituitary downregulation with GnRH-a, prior to ART.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 22 Oct 2018
- Start date
- Oct 2023
- Primary completion date
- Oct 2025
- Lead sponsor
- Università degli Studi dell'Insubria
- Diseases
- Endometriosis
- NCT number
- NCT03717870
What you commit to
- Study type: Interventional
- Planned participants: 100
- From Oct 2023 to the primary completion date, Oct 2025
- No sites listed in no 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
- Previous ovarian surgery.
Other
- Any comorbidity other than ovarian endometrioma.
- Deep Infiltrating Endometriosis.
- Bilateral endometriomas.
- The use of donor oocytes/sperm.
- ART with preimplantation genetic testing, as the number of embryos suitable. for transfer or cryopreservation is significantly lower compared to normal ART.
Who the study is looking for
- Indication for ART: compromised tubal function, male factor infertility, other treatments have failed and/or prolonged infertility of more than 4 years.
- Age between 18 and 35 years.
- Ultrasound diagnosis of one ovarian endometriotic cyst with a diameter of 30 mm or more, according to the International Ovarian Tumor Analysis (IOTA)-criteria for reliable diagnosis of endometriomas in premenopausal women.
Age in the registry: 18 years to 35 years · Sex: Female · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.