Surgery and ART For Endometrioma

Not Applicable

Not yet recruiting

• Conditions: Ovarian Endometrioma; Infertility, Female
• Interventions: Procedure: Prolonged pituitary downregulation; Procedure: Laparoscopic enucleation of ovarian endometrioma.; Procedure: Assisted Reproductive Technology (ART)

• Registration Number: NCT03717870
• Lead Sponsor: Università degli Studi dell'Insubria

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-22
• Study First Submitted QC: 2018-10-23
• Study First Posted: 2018-10-24
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-28
• Last Update Posted: 2021-04-29
• Study Start: 2023-10
• Primary Completion: 2025-10
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prolonged pituitary downregulation	Assisted Reproductive Technology (ART)	Treatment with GnRH-a (triptorelin, goserelin, and leuprolide), with add-back therapy (combined oral contraceptive) for 3-6 months.
Surgery	Assisted Reproductive Technology (ART)	Laparoscopic enucleation of ovarian endometrioma (stripping of the peripheral capsule and coagulation using the lowest energy source available).
Prolonged pituitary downregulation	Prolonged pituitary downregulation	Treatment with GnRH-a (triptorelin, goserelin, and leuprolide), with add-back therapy (combined oral contraceptive) for 3-6 months.
Surgery	Laparoscopic enucleation of ovarian endometrioma.	Laparoscopic enucleation of ovarian endometrioma (stripping of the peripheral capsule and coagulation using the lowest energy source available).

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy with fetal heartbeat	Within 8 weeks from embryo transfer	Ultrasound-confirmed intrauterine pregnancy with fetal heartbeat

Secondary Outcome Measures

Name	Time	Method
Live birth rate	Within 41 weeks from embryo transfer	Delivered fetus after 28 gestational weeks
Biochemical pregnancy	Within 8 weeks from embryo transfer	Positive HCG serum testing
Miscarriage	Within 12 weeks from embryo transfer	Ultrasound-confirmed abortion