Surgery and ART For Endometrioma

• ClinicalTrials.gov Identifier: NCT03717870
• Recruitment Status: Not yet recruiting
• First Posted: October 24, 2018
• Last Update Posted: March 24, 2020
• Sponsor: Università degli Studi dell'Insubria
• Information provided by (Responsible Party): Antonio Simone Laganà, Università degli Studi dell'Insubria

Tracking Information

• First Submitted Date: October 22, 2018
• First Posted Date: October 24, 2018
• Last Update Posted Date: March 24, 2020
• Estimated Study Start Date: October 2023
• Estimated Primary Completion Date: October 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 23, 2018)

Clinical pregnancy with fetal heartbeat [ Time Frame: Within 8 weeks from embryo transfer ]

Ultrasound-confirmed intrauterine pregnancy with fetal heartbeat

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 23, 2018)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Surgery and ART For Endometrioma
• Official Title: 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

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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomized Controlled Trial

Masking: None (Open Label)
Primary Purpose: Treatment

Condition

• Ovarian Endometrioma
• Infertility, Female

Intervention

• Procedure: Laparoscopic enucleation of ovarian endometrioma.
  Laparoscopic enucleation of ovarian endometrioma (stripping of the peripheral capsule and coagulation using the lowest energy source available).
• Procedure: Prolonged pituitary downregulation
  Treatment with GnRH-a (triptorelin, goserelin, and leuprolide), with add-back therapy (combined oral contraceptive) for 3-6 months.
• Procedure: Assisted Reproductive Technology (ART)
  Fresh ART cycle: ovarian stimulation, oocyte retrieval, in vitro fertilization and embryo transfer.

Study Arms

• Experimental: Surgery
  Laparoscopic enucleation of ovarian endometrioma (stripping of the peripheral capsule and coagulation using the lowest energy source available).
  Interventions:

  • Procedure: Laparoscopic enucleation of ovarian endometrioma.
  • Procedure: Assisted Reproductive Technology (ART)
• Active Comparator: Prolonged pituitary downregulation
  Treatment with GnRH-a (triptorelin, goserelin, and leuprolide), with add-back therapy (combined oral contraceptive) for 3-6 months.
  Interventions:

  • Procedure: Prolonged pituitary downregulation
  • Procedure: Assisted Reproductive Technology (ART)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: October 23, 2018): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 2027
• Estimated Primary Completion Date: October 2025 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 35 Years (Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Antonio Simone Laganà, M.D.; +393296279579; antoniosimone.lagana@asst-settelaghi.it

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03717870
• Other Study ID Numbers: SAFE-1
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Antonio Simone Laganà, Università degli Studi dell'Insubria
• Study Sponsor: Università degli Studi dell'Insubria
• Collaborators: Not Provided

Investigators

• Principal Investigator: Antonio Simone Laganà, M.D.; Università degli Studi dell'Insubria

• PRS Account: Università degli Studi dell'Insubria
• Verification Date: March 2020