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Surgery and ART For Endometrioma

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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Ovarian Endometrioma Infertility, Female Procedure: Laparoscopic enucleation of ovarian endometrioma. Procedure: Prolonged pituitary downregulation Procedure: Assisted Reproductive Technology (ART) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : October 2023
Estimated Primary Completion Date : October 2025
Estimated Study Completion Date : October 2027

Resource links provided by the National Library of Medicine


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


Outcome Measures
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Primary Outcome Measures :
  1. Clinical pregnancy with fetal heartbeat [ Time Frame: Within 8 weeks from embryo transfer ]
    Ultrasound-confirmed intrauterine pregnancy with fetal heartbeat


Secondary Outcome Measures :
  1. Biochemical pregnancy [ Time Frame: Within 8 weeks from embryo transfer ]
    Positive HCG serum testing

  2. Miscarriage [ Time Frame: Within 12 weeks from embryo transfer ]
    Ultrasound-confirmed abortion

  3. Live birth rate [ Time Frame: Within 41 weeks from embryo transfer ]
    Delivered fetus after 28 gestational weeks


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03717870


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

Sponsors and Collaborators
Università degli Studi dell'Insubria
Investigators
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Principal Investigator: Antonio Simone Laganà, M.D. Università degli Studi dell'Insubria
More Information
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Responsible Party: Antonio Simone Laganà, Principal Investigator, Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier: NCT03717870    
Other Study ID Numbers: SAFE-1
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Antonio Simone Laganà, Università degli Studi dell'Insubria:
Endometrioma
Infertility
Laparoscopy
 GnRH-a
Assisted Reproduction Technology
Reproductive outcomes
Additional relevant MeSH terms:
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Infertility
Infertility, Female
Endometriosis