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Clinical Trials/NCT03717870
NCT03717870
Not yet recruiting
Not Applicable

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

Università degli Studi dell'Insubria0 sites100 target enrollmentOctober 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ovarian Endometrioma
Sponsor
Università degli Studi dell'Insubria
Enrollment
100
Primary Endpoint
Clinical pregnancy with fetal heartbeat
Status
Not yet recruiting
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2023
End Date
October 2027
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Università degli Studi dell'Insubria
Responsible Party
Principal Investigator
Principal Investigator

Antonio Simone Laganà

Principal Investigator

Università degli Studi dell'Insubria

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Clinical pregnancy with fetal heartbeat

Time Frame: Within 8 weeks from embryo transfer

Ultrasound-confirmed intrauterine pregnancy with fetal heartbeat

Secondary Outcomes

  • Biochemical pregnancy(Within 8 weeks from embryo transfer)
  • Miscarriage(Within 12 weeks from embryo transfer)
  • Live birth rate(Within 41 weeks from embryo transfer)

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