An interventional study of Laparoscopic enucleation of ovarian endometrioma. and Prolonged pituitary downregulation in Ovarian Endometrioma and Infertility, Female, sponsored by Università degli Studi dell'Insubria. Not yet recruiting. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2021-04-29.
Sponsored by Università degli Studi dell'Insubria · Not applicable, Interventional, and Treatment
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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.
921 studies on the registry are indexed under Endometriosis; 267 are open to participants now.
This study's planned enrollment of 100 is above the median of 67 across 541 interventional studies indexed under Endometriosis.
Browse Endometriosis studies →Università degli Studi dell'Insubria is the lead sponsor of 68 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
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)
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)
Laparoscopic enucleation of ovarian endometrioma (stripping of the peripheral capsule and coagulation using the lowest energy source available).
Treatment with GnRH-a (triptorelin, goserelin, and leuprolide), with add-back therapy (combined oral contraceptive) for 3-6 months.
Fresh ART cycle: ovarian stimulation, oocyte retrieval, in vitro fertilization and embryo transfer.
Clinical pregnancy with fetal heartbeat
Ultrasound-confirmed intrauterine pregnancy with fetal heartbeat
Time frame: Within 8 weeks from embryo transfer
Biochemical pregnancy
Positive HCG serum testing
Time frame: Within 8 weeks from embryo transfer
Miscarriage
Ultrasound-confirmed abortion
Time frame: Within 12 weeks from embryo transfer
Live birth rate
Delivered fetus after 28 gestational weeks
Time frame: Within 41 weeks from embryo transfer
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Oct 2023; primary completion for Oct 2025, 24 months later.
Of 198 non-industry interventional studies with no phase under Endometriosis, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 44. This study's planned 24 months is close to that.
Counting every sponsor, half of 213 studies reached it within 25 months; a quarter within 13 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Università degli Studi dell'Insubria