Surgery and ART For Endometrioma
Primary Purpose
Ovarian Endometrioma, Infertility, Female
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laparoscopic enucleation of ovarian endometrioma.
Prolonged pituitary downregulation
Assisted Reproductive Technology (ART)
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Endometrioma focused on measuring Endometrioma, Infertility, Laparoscopy, GnRH-a, Assisted Reproduction Technology, Reproductive outcomes
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Surgery
Prolonged pituitary downregulation
Arm Description
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.
Outcomes
Primary Outcome Measures
Clinical pregnancy with fetal heartbeat
Ultrasound-confirmed intrauterine pregnancy with fetal heartbeat
Secondary Outcome Measures
Biochemical pregnancy
Positive HCG serum testing
Miscarriage
Ultrasound-confirmed abortion
Live birth rate
Delivered fetus after 28 gestational weeks
Full Information
NCT ID
NCT03717870
First Posted
October 22, 2018
Last Updated
April 28, 2021
Sponsor
Università degli Studi dell'Insubria
1. Study Identification
Unique Protocol Identification Number
NCT03717870
Brief Title
Surgery and ART For Endometrioma
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università degli Studi dell'Insubria
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Endometrioma, Infertility, Female
Keywords
Endometrioma, Infertility, Laparoscopy, GnRH-a, Assisted Reproduction Technology, Reproductive outcomes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Surgery
Arm Type
Experimental
Arm Description
Laparoscopic enucleation of ovarian endometrioma (stripping of the peripheral capsule and coagulation using the lowest energy source available).
Arm Title
Prolonged pituitary downregulation
Arm Type
Active Comparator
Arm Description
Treatment with GnRH-a (triptorelin, goserelin, and leuprolide), with add-back therapy (combined oral contraceptive) for 3-6 months.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic enucleation of ovarian endometrioma.
Intervention Description
Laparoscopic enucleation of ovarian endometrioma (stripping of the peripheral capsule and coagulation using the lowest energy source available).
Intervention Type
Procedure
Intervention Name(s)
Prolonged pituitary downregulation
Intervention Description
Treatment with GnRH-a (triptorelin, goserelin, and leuprolide), with add-back therapy (combined oral contraceptive) for 3-6 months.
Intervention Type
Procedure
Intervention Name(s)
Assisted Reproductive Technology (ART)
Intervention Description
Fresh ART cycle: ovarian stimulation, oocyte retrieval, in vitro fertilization and embryo transfer.
Primary Outcome Measure Information:
Title
Clinical pregnancy with fetal heartbeat
Description
Ultrasound-confirmed intrauterine pregnancy with fetal heartbeat
Time Frame
Within 8 weeks from embryo transfer
Secondary Outcome Measure Information:
Title
Biochemical pregnancy
Description
Positive HCG serum testing
Time Frame
Within 8 weeks from embryo transfer
Title
Miscarriage
Description
Ultrasound-confirmed abortion
Time Frame
Within 12 weeks from embryo transfer
Title
Live birth rate
Description
Delivered fetus after 28 gestational weeks
Time Frame
Within 41 weeks from embryo transfer
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio Simone Laganà, M.D.
Phone
+393296279579
Email
antoniosimone.lagana@asst-settelaghi.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Simone Laganà, M.D.
Organizational Affiliation
Università degli Studi dell'Insubria
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Surgery and ART For Endometrioma
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