Skip to content

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03717870
Enrollment
100
Registered
2018-10-24
Start date
2023-10-31
Completion date
2027-10-31
Last updated
2021-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Female, Ovarian Endometrioma

Keywords

Endometrioma, Infertility, Laparoscopy, GnRH-a, Assisted Reproduction Technology, Reproductive outcomes

Brief summary

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.

Interventions

PROCEDURELaparoscopic enucleation of ovarian endometrioma.

Laparoscopic enucleation of ovarian endometrioma (stripping of the peripheral capsule and coagulation using the lowest energy source available).

PROCEDUREProlonged pituitary downregulation

Treatment with GnRH-a (triptorelin, goserelin, and leuprolide), with add-back therapy (combined oral contraceptive) for 3-6 months.

PROCEDUREAssisted Reproductive Technology (ART)

Fresh ART cycle: ovarian stimulation, oocyte retrieval, in vitro fertilization and embryo transfer.

Sponsors

Università degli Studi dell'Insubria
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Randomized Controlled Trial

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* Any comorbidity other than ovarian endometrioma. * Deep Infiltrating Endometriosis. * Previous ovarian surgery. * 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.

Design outcomes

Primary

MeasureTime frameDescription
Clinical pregnancy with fetal heartbeatWithin 8 weeks from embryo transferUltrasound-confirmed intrauterine pregnancy with fetal heartbeat

Secondary

MeasureTime frameDescription
Biochemical pregnancyWithin 8 weeks from embryo transferPositive HCG serum testing
MiscarriageWithin 12 weeks from embryo transferUltrasound-confirmed abortion
Live birth rateWithin 41 weeks from embryo transferDelivered fetus after 28 gestational weeks

Contacts

Primary ContactAntonio Simone Laganà, M.D.
antoniosimone.lagana@asst-settelaghi.it+393296279579

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026