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

NCT07267754 | Not Yet Recruiting DMC

• 2 other identifiers: San Carlo PHComitato Etico Unico Regionale
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Pregnancy Rate IVF; Clinical Pregnancy Rate; Live Birth Rate

Keywords

Oocyte retrieval; Interstitial myolysis; Assisted Reproductive Technology

Outcome Measures

Primary Outcomes (6)

• 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

  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

Secondary Outcomes (2)

• Post- surgical bleeding

  30 days

• Post surgical sepsis

  30 days

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Infertile women with uterine fibroids who need to undergo oocytes retrieval between 18 and 45years old
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• Infertile women with uterine fibroids who need to undergo oocytes retrieval between 18 and 45years old

You may not qualify if:

• Fertile woman with uterine fibroids Fertile women without uterine fibroids Women under 18 years old Woman over 45 years old

Sponsors & Collaborators

• San Carlo Public Hospital, Potenza, Italy: lead

Study Sites (1)

San Carlo Public Hospital, Potenza -Italy

Potenza, PZ, 85100, Italy

Location

Related Publications (4)

• 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.

  PMID: 26733265 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.

  PMID: 36049885 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.

  PMID: 39697096 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.

  PMID: 40209488 BACKGROUND

Related Links

• Related Info

Study Officials

• Assunta Iuliano, Principal Investigator

  San Carlo Public Hospital, Potenza, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Assunta Iuliano, Principal Investigator

CONTACT

+393496330637; susy.iuliano@gmail.com

Sergio C Schettini, Direttore di Dipartimento

CONTACT

+390971613156; schettini@mac.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 5, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 30, 2027
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)