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| ID | Type | Description | Link |
|---|---|---|---|
| Comitato Etico Unico Regionale | Other Identifier | San Carlo Public Hospital, Potenza-Italy |
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The aim of this observational cohort study is to evaluate the pregnancy rate, the ongoing pregnancy rate and the live birth rate of infertile women aged between 18 and 45 years who undergo a single surgical step of oocyte retrieval and uterine interstitial myolisis .
The main questions of these study are:
Women undergoing oocyte retrieval will agree to undergo oocyte retrieval and interstitial myolysis at the same time, to freeze their blastocysts and to transfer them into the uterus after 6 months
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| infertile patients undergoing oocyte retrieval affected by uterine myomatosis | Women affected by any form of infertility aged between 18 and 45 years with uterine myomatosis who are undergoing oocyte retrieval |
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| Measure | Description | Time Frame |
|---|---|---|
| Chance of pregnancy after frozen embryotransfer | The researchers' primary objective is to calculate the pregnancy rate, miscarrage rate and live birth rate of the number of embryo transfers performed in the patients enrolled in the study. The pregnancy rate % per embryo transfer is a mesure of success of an embryo transfer procedure and it is calculated as follow: (number of clinical pregnancy/number of embryo trasnfer) x 100. The miscarriage %per embryo transfer is a measure of the risk of miscarrage following transfer procedure and it is calulated as follows: ( number of miscarrage/number of clinical pregnancies) x 100. The live birth rate % per embryo transfer is a measure of the success of an embryo transfer procedure in achieving a live birth and it is calculated as follows: ( number of live biths/number of embryo transfer) x 100. | From the transfer of the thawed blastocyst to the birth of the baby. 18 months |
| IVF/ICSI outcome | Il tasso di gravidanza per trasferimento di embrioni è calcolato come segue: (numero di gravidanze cliniche/numero di trasferimento di embrioni) x 100. L'aborto spontaneo per trasferimento di embrioni è una misura del rischio di aborto spontaneo ed è calcolato come segue: (numero di aborti spontanei/numero di gravidanze cliniche) x 100. Il tasso di nati vivi per trasferimento di embrioni è una misura del successo di una procedura di trasferimento di embrioni nel raggiungimento di un parto vivo ed è calcolato come segue: (numero di nati vivi/numero di trasferimenti di embrioni) x 100. | 18 month |
| Pregnancy Rate | (Number of clinical pregnancies/ Number of embryo transfers) x 100 | 18 months after oocytes retrieval and interstitial myolysis |
| Post surgical pelvic organ injury | Post surgical pelvic organ injury refers to any structural or functional damage to the organs within the pelvic cavity ( such as the bladder, uterus, ovaries, rectum or neurovascular structures) that occurs as a direct result of a surgical procedure. This injury may manifest as perforation, laceration, devascularization or impaired organ function and is diagnosed based on clinicalsigns, imaging or intraoperative findings |
| Measure | Description | Time Frame |
|---|---|---|
| Post- surgical bleeding | Post surgical bleeding is a substantial loss ofl blood after oocytes retrieval or after interstial myolisis, involving the loss of at lest one gram of hemoglobin | 30 days |
| Post surgical sepsis |
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Inclusion Criteria:
Infertile women with uterine fibroids who need to undergo oocytes retrieval between 18 and 45years old
Exclusion Criteria:
Fertile woman with uterine fibroids Fertile women without uterine fibroids Women under 18 years old Woman over 45 years old
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Infertile women with uterine fibroids who need to undergo oocytes retrieval between 18 and 45years old
Infertile women between 18 and 45 yearsvold whith uterine fibroids who need to undergo oocyte retrieval at the "San Carlo" Medically Assisted Reproduction Center - Potenza, Italy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Assunta Iuliano, Principal Investigator | Contact | +393496330637 | +390971612241 | susy.iuliano@gmail.com |
| Sergio C Schettini, Direttore di Dipartimento | Contact | +390971613156 | schettini@mac.com |
| Name | Affiliation | Role |
|---|---|---|
| Assunta Iuliano, Principal Investigator | San Carlo Public Hospital, Potenza, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Carlo Public Hospital, Potenza -Italy | Potenza | PZ | 85100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26733265 | Background | Bing-song Z, Jing Z, Zhi-Yu H, Chang-tao X, Rui-fang X, Xiu-mei L, Hui L. Unplanned pregnancy after ultrasound-guided percutaneous microwave ablation of uterine fibroids: A follow-up study. Sci Rep. 2016 Jan 6;6:18924. doi: 10.1038/srep18924. | |
| 36049885 | Background | Beermann M, Jonsdottir G, Cronisoe A, Hasselrot K, Kopp Kallner H. Long term follow-up of uterine fibroids treated with microwave ablation: an up to 3-year observational study of volume, regrowth, and symptoms. Int J Hyperthermia. 2022;39(1):1158-1163. doi: 10.1080/02656736.2022.2109764. |
| Label | URL |
|---|---|
| Related Info | View source |
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| 30 days |
| miscarriage rate | Number of miscarriages ( spntaneous abortions)/Number of clinicla pregnancies( x 100 | 18 months |
| Live Birth Rate | /Number of live births/ Number of embryo transfers ) x 100 | 18 months |
Post surgical sepsis is a life-threatening systemic infection that develops within 30 days after a surgical procedure. It is characterzed by a dysregulatedhost response to infection, leading to organ dysfuncyion or failure. The condition requires prompt recognition, source control and broad-spectrum antimicrobial therapy to improve outcome
| 30 days |
| 39697096 | Background | Jonsdottir G, Beermann M, Lanz E, Nikodell A, Cronsioe A, Hasselrot K, Kopp-Kallner H. Ultrasound guided microwave ablation treatment of uterine fibroids: Clinical response and patient acceptability. Acta Obstet Gynecol Scand. 2025 Feb;104(2):350-356. doi: 10.1111/aogs.15041. Epub 2024 Dec 19. |
| 40209488 | Background | Ahmad F, Khan AI, Asif A, Ahmed S, Nisar M, Fatima E, Khan F, Razzaq A, Tahir A, Khalid AR, Azeemuddin M. Clinical Efficacy of Percutaneous Microwave Ablation in Treating Uterine Fibroids: A Comprehensive Systematic Review and Meta-Analysis. Eur J Obstet Gynecol Reprod Biol. 2025 Jun;310:113954. doi: 10.1016/j.ejogrb.2025.113954. Epub 2025 Apr 5. |