Uterine Interstitial Myolisis and Oocytes Retrieval in Single Step: a Pilot Study

NCT ID: NCT07267754

Last Updated: 2025-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-01

Study Completion Date

2027-01-30

Brief Summary

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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:

1. 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?
2. 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

Detailed Description

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Conditions

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Pregnancy Rate IVF Clinical Pregnancy Rate Live Birth Rate

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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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Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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San Carlo Public Hospital, Potenza, Italy

OTHER

Sponsor Role lead

Responsible Party

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Assunta Iuliano, MD

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Assunta Iuliano, Principal Investigator

Role: PRINCIPAL_INVESTIGATOR

San Carlo Public Hospital, Potenza, Italy

Locations

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San Carlo Public Hospital, Potenza -Italy

Potenza, PZ, Italy

Site Status

Countries

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Italy

Central Contacts

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Assunta Iuliano, Principal Investigator

Role: CONTACT

+393496330637 ext. +390971612241

Sergio C Schettini, Direttore di Dipartimento

Role: CONTACT

+390971613156

References

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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.

Reference Type BACKGROUND
PMID: 26733265 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36049885 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39697096 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 40209488 (View on PubMed)

Other Identifiers

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Comitato Etico Unico Regionale

Identifier Type: OTHER

Identifier Source: secondary_id

San Carlo PH

Identifier Type: -

Identifier Source: org_study_id

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