Surgery and ART For Endometrioma

NCT03717870 | Not Yet Recruiting

• 1 other identifier: SAFE-1
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ovarian Endometrioma; Infertility, Female

Keywords

Endometrioma; Infertility; Laparoscopy; GnRH-a; Assisted Reproduction Technology; Reproductive outcomes

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy with fetal heartbeat

  Ultrasound-confirmed intrauterine pregnancy with fetal heartbeat

  Within 8 weeks from embryo transfer

Secondary Outcomes (3)

• Biochemical pregnancy

  Within 8 weeks from embryo transfer

• Miscarriage

  Within 12 weeks from embryo transfer

• Live birth rate

  Within 41 weeks from embryo transfer

Study Arms (2)

Surgery

EXPERIMENTAL

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

Procedure: Laparoscopic enucleation of ovarian endometrioma.; Procedure: Assisted Reproductive Technology (ART)

Prolonged pituitary downregulation

ACTIVE COMPARATOR

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

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

Interventions

Laparoscopic enucleation of ovarian endometrioma. PROCEDURE

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

Surgery

Prolonged pituitary downregulation PROCEDURE

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

Prolonged pituitary downregulation

Assisted Reproductive Technology (ART) PROCEDURE

Fresh ART cycle: ovarian stimulation, oocyte retrieval, in vitro fertilization and embryo transfer.

Prolonged pituitary downregulation; Surgery

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Università degli Studi dell'Insubria: lead

MeSH Terms

Conditions

Endometriosis; Infertility, Female; Infertility

Interventions

Reproductive Techniques, Assisted

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Reproductive Techniques; Therapeutics; Investigative Techniques

Study Officials

• Antonio Simone Laganà, M.D.

  Università degli Studi dell'Insubria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Simone Laganà, M.D.

CONTACT

+393296279579; antoniosimone.lagana@asst-settelaghi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: October 24, 2018
• Study Start: October 1, 2023
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 29, 2021

Record last verified: 2021-04