Pregnancy Rate IVFUIMandOPUNCT07267754
Uterine Interstitial Myolisis and Oocytes Retrieval in Single Step: a Pilot Study
An observational study of Pregnancy Rate IVF and Clinical Pregnancy Rate, run by San Carlo Public Hospital, Potenza, Italy at 1 site in Italy.
Trial summary
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: 1. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pregnancy Rate IVF, Clinical Pregnancy Rate, Live Birth Rate
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2026to 30 Jan 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: 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
Who may be able to join
- Infertile women with uterine fibroids who need to undergo oocytes retrieval between 18 and 45years old
Who cannot join
- Fertile woman with uterine fibroids Fertile women without uterine fibroids Women under 18 years old Woman over 45 years old
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Assunta Iuliano, Principal Investigator contact
About this study
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:
Read more
- What is the chances of a positive pregnancy test and what is the chances of live birth for women who undergo oocyte retrieval and interstitial myolysis in a single surgical step?
- Are there any complications associated with performing the two surgical techniques at the same time? Researchers will calculate IVF/ICSI outcomes after embryotransfer of vitrified blastocystis obtained after oocyte retrieval and subsequent interstitial myolysis.
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
- Conditions
- Pregnancy Rate IVF, Clinical Pregnancy Rate, Live Birth Rate
- Keywords
- Oocyte retrieval, Interstitial myolysis, Assisted Reproductive Technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 18 month
Pregnancy Rate
(Number of clinical pregnancies/ Number of embryo transfers) x 100
Measured: 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
Measured: 30 days
miscarriage rate
Number of miscarriages ( spntaneous abortions)/Number of clinicla pregnancies( x 100
Measured: 18 months
Live Birth Rate
/Number of live births/ Number of embryo transfers ) x 100
Measured: 18 months
Secondary outcomes (2)
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
Measured: 30 days
Post surgical sepsis
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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pregnancy Rate IVFStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- San Carlo Public Hospital, Potenza, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Assunta Iuliano, MD, San Carlo Public Hospital, Potenza, Italy
- Investigators
- Assunta Iuliano, Principal Investigator, Principal investigator, San Carlo Public Hospital, Potenza, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07267754
- Sponsor's protocol ID
- San Carlo PH
- Other IDs
- Comitato Etico Unico Regionale
- Acronym
- UIMandOPU
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26733265Beermann 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.
PubMed 36049885Jonsdottir 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.
PubMed 39697096Ahmad 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.
PubMed 40209488
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uterine Interstitial Myolisis and Oocytes Retrieval in Single Step: a Pilot Study
- ClinicalTrials.gov ID
- NCT07267754
- Acronym / sponsor ID
- UIMandOPU / San Carlo PH
- Conditions
- Pregnancy Rate IVF, Clinical Pregnancy Rate, Live Birth Rate
- Keywords
- Oocyte retrieval, Interstitial myolysis, Assisted Reproductive Technology
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- San Carlo Public Hospital, Potenza, ItalyUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What is the chances of a positive pregnancy test and what is the chances of live birth for women who undergo oocyte retrieval and interstitial myolysis in a single surgical step?
- Are there any complications associated with performing the two surgical techniques at the same time? Researchers will calculate IVF/ICSI outcomes after embryotransfer of vitrified blastocystis obtained after oocyte retrieval and subsequent interstitial myolysis.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 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
Key inclusion criteria (1 listed)
- Infertile women with uterine fibroids who need to undergo oocytes retrieval between 18 and 45years old
Key exclusion criteria (2 listed)
- Fertile woman with uterine fibroids Fertile women without uterine fibroids Women under 18 years old Woman over 45 years old
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Chance of pregnancy after frozen embryotransfer
Time frame: From the transfer of the thawed blastocyst to the birth of the baby. 18 months
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.
IVF/ICSI outcome
Time frame: 18 month
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.
Pregnancy Rate
Time frame: 18 months after oocytes retrieval and interstitial myolysis
(Number of clinical pregnancies/ Number of embryo transfers) x 100
Post surgical pelvic organ injury
Time frame: 30 days
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
miscarriage rate
Time frame: 18 months
Number of miscarriages ( spntaneous abortions)/Number of clinicla pregnancies( x 100
Live Birth Rate
Time frame: 18 months
/Number of live births/ Number of embryo transfers ) x 100
2 secondary outcomes
Post- surgical bleeding
Time frame: 30 days
Post surgical sepsis
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Background: PubMed 26733265Bing-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.
- Background: PubMed 36049885Beermann 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.
- Background: PubMed 39697096Jonsdottir 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.
- Background: PubMed 40209488Ahmad 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Assunta Iuliano, Principal Investigator contact
Assunta Iuliano, Principal Investigator principal investigator
San Carlo Public Hospital, Potenza, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Rate IVF and Clinical Pregnancy Rate, run by San Carlo Public Hospital, Potenza, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Assunta Iuliano, Principal Investigator (+393496330637 ext. +390971612241, susy.iuliano@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chance of pregnancy after frozen embryotransfer (time frame: From the transfer of the thawed blastocyst to the birth of the baby. 18 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07267754, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.