Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Surgery and ART For Endometrioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03717870
Recruitment Status : Not yet recruiting
First Posted : October 24, 2018
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Antonio Simone Laganà, Università degli Studi dell'Insubria

Tracking Information
First Submitted Date  ICMJE October 22, 2018
First Posted Date  ICMJE October 24, 2018
Last Update Posted Date March 24, 2020
Estimated Study Start Date  ICMJE October 2023
Estimated Primary Completion Date October 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Surgery and ART For Endometrioma
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized Controlled Trial
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Ovarian Endometrioma
  • Infertility, Female
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 23, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2027
Estimated Primary Completion Date October 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Antonio Simone Laganà, M.D. +393296279579 antoniosimone.lagana@asst-settelaghi.it
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03717870
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: Undecided
Responsible Party Antonio Simone Laganà, Università degli Studi dell'Insubria
Study Sponsor  ICMJE Università degli Studi dell'Insubria
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Antonio Simone Laganà, M.D. Università degli Studi dell'Insubria
PRS Account Università degli Studi dell'Insubria
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP