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Not yet recruiting NCT03717870

Surgery and ART For Endometrioma

No phase Interventional Ovarian Endometrioma Infertility, Female

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Laparoscopic enucleation of ovarian endometrioma., Prolonged pituitary downregulation, Assisted Reproductive Technology (ART).
Who it may be relevant to
Registry conditions: Ovarian Endometrioma, Infertility, Female. Basic parameters: 18 years — 35 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Clinical pregnancy with fetal heartbeat [Time frame: Within 8 weeks from embryo transfer]
Secondary outcome measures (3)
  • Biochemical pregnancy [Time frame: Within 8 weeks from embryo transfer]
  • Miscarriage [Time frame: Within 12 weeks from embryo transfer]
  • Live birth rate [Time frame: Within 41 weeks from embryo transfer]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT03717870 · SAFE-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗