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Surgery and ART For Endometrioma

Primary Purpose

Ovarian Endometrioma, Infertility, Female

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laparoscopic enucleation of ovarian endometrioma.
Prolonged pituitary downregulation
Assisted Reproductive Technology (ART)
Sponsored by
Università degli Studi dell'Insubria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Endometrioma focused on measuring Endometrioma, Infertility, Laparoscopy, GnRH-a, Assisted Reproduction Technology, Reproductive outcomes

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Surgery

    Prolonged pituitary downregulation

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Clinical pregnancy with fetal heartbeat
    Ultrasound-confirmed intrauterine pregnancy with fetal heartbeat

    Secondary Outcome Measures

    Biochemical pregnancy
    Positive HCG serum testing
    Miscarriage
    Ultrasound-confirmed abortion
    Live birth rate
    Delivered fetus after 28 gestational weeks

    Full Information

    First Posted
    October 22, 2018
    Last Updated
    April 28, 2021
    Sponsor
    Università degli Studi dell'Insubria
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03717870
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    October 2025 (Anticipated)
    Study Completion Date
    October 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Università degli Studi dell'Insubria

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ovarian Endometrioma, Infertility, Female
    Keywords
    Endometrioma, Infertility, Laparoscopy, GnRH-a, Assisted Reproduction Technology, Reproductive outcomes

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized Controlled Trial
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Surgery
    Arm Type
    Experimental
    Arm Description
    Laparoscopic enucleation of ovarian endometrioma (stripping of the peripheral capsule and coagulation using the lowest energy source available).
    Arm Title
    Prolonged pituitary downregulation
    Arm Type
    Active Comparator
    Arm Description
    Treatment with GnRH-a (triptorelin, goserelin, and leuprolide), with add-back therapy (combined oral contraceptive) for 3-6 months.
    Intervention Type
    Procedure
    Intervention Name(s)
    Laparoscopic enucleation of ovarian endometrioma.
    Intervention Description
    Laparoscopic enucleation of ovarian endometrioma (stripping of the peripheral capsule and coagulation using the lowest energy source available).
    Intervention Type
    Procedure
    Intervention Name(s)
    Prolonged pituitary downregulation
    Intervention Description
    Treatment with GnRH-a (triptorelin, goserelin, and leuprolide), with add-back therapy (combined oral contraceptive) for 3-6 months.
    Intervention Type
    Procedure
    Intervention Name(s)
    Assisted Reproductive Technology (ART)
    Intervention Description
    Fresh ART cycle: ovarian stimulation, oocyte retrieval, in vitro fertilization and embryo transfer.
    Primary Outcome Measure Information:
    Title
    Clinical pregnancy with fetal heartbeat
    Description
    Ultrasound-confirmed intrauterine pregnancy with fetal heartbeat
    Time Frame
    Within 8 weeks from embryo transfer
    Secondary Outcome Measure Information:
    Title
    Biochemical pregnancy
    Description
    Positive HCG serum testing
    Time Frame
    Within 8 weeks from embryo transfer
    Title
    Miscarriage
    Description
    Ultrasound-confirmed abortion
    Time Frame
    Within 12 weeks from embryo transfer
    Title
    Live birth rate
    Description
    Delivered fetus after 28 gestational weeks
    Time Frame
    Within 41 weeks from embryo transfer

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Antonio Simone Laganà, M.D.
    Phone
    +393296279579
    Email
    antoniosimone.lagana@asst-settelaghi.it
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Antonio Simone Laganà, M.D.
    Organizational Affiliation
    Università degli Studi dell'Insubria
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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