Surgery and ART For Endometrioma

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-35
SponsorUniversità degli Studi dell'Insubria

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Any comorbidity other than ovarian endometrioma.

Deep Infiltrating Endometriosis.

Previous ovarian surgery.

Bilateral endometriomas.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Laparoscopic enucleation of ovarian endometrioma.

    Procedure/Surgery

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

  • Prolonged pituitary downregulation

    Procedure/Surgery

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

  • Assisted Reproductive Technology (ART)

    Procedure/Surgery

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: SurgeryExperimental treatment 2 interventions
Group B: Prolonged pituitary downregulationActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Clinical pregnancy with fetal heartbeat

Ultrasound-confirmed intrauterine pregnancy with fetal heartbeat

Time frame
Within 8 weeks from embryo transfer

Secondary outcomes

1

Biochemical pregnancy

Positive HCG serum testing

Time frame
Within 8 weeks from embryo transfer
2

Miscarriage

Ultrasound-confirmed abortion

Time frame
Within 12 weeks from embryo transfer
3

Live birth rate

Delivered fetus after 28 gestational weeks

Time frame
Within 41 weeks from embryo transfer

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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