About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Any comorbidity other than ovarian endometrioma.
Deep Infiltrating Endometriosis.
Previous ovarian surgery.
Bilateral endometriomas.
Trial design
Parallel
Treatments tested in this trial
Laparoscopic enucleation of ovarian endometrioma.
Procedure/SurgeryLaparoscopic enucleation of ovarian endometrioma (stripping of the peripheral capsule and coagulation using the lowest energy source available).
Prolonged pituitary downregulation
Procedure/SurgeryTreatment with GnRH-a (triptorelin, goserelin, and leuprolide), with add-back therapy (combined oral contraceptive) for 3-6 months.
Assisted Reproductive Technology (ART)
Procedure/SurgeryFresh ART cycle: ovarian stimulation, oocyte retrieval, in vitro fertilization and embryo transfer.
Treatment groups
Trial outcomes
Primary outcomes
Clinical pregnancy with fetal heartbeat
Ultrasound-confirmed intrauterine pregnancy with fetal heartbeat
Secondary outcomes
Biochemical pregnancy
Positive HCG serum testing
Miscarriage
Ultrasound-confirmed abortion
Live birth rate
Delivered fetus after 28 gestational weeks
Locations
Sponsors and contacts
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