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

November 25, 2025 updated by: Assunta Iuliano, MD, San Carlo Public Hospital, Potenza, Italy

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

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Assunta Iuliano, Principal Investigator
  • Phone Number: +390971612241 +393496330637
  • Email: susy.iuliano@gmail.com

Study Contact Backup

  • Name: Sergio C Schettini, Direttore di Dipartimento
  • Phone Number: +390971613156
  • Email: schettini@mac.com

Study Locations

  • Italy
    • PZ
      • Potenza, PZ, Italy, 85100
        • San Carlo Public Hospital, Potenza -Italy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

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

Description

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the transfer of the thawed blastocyst to the birth of the baby. 18 months
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.
18 month
Pregnancy Rate
Time Frame: 18 months after oocytes retrieval and interstitial myolysis
(Number of clinical pregnancies/ Number of embryo transfers) x 100
18 months after oocytes retrieval and interstitial myolysis
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
30 days
miscarriage rate
Time Frame: 18 months
Number of miscarriages ( spntaneous abortions)/Number of clinicla pregnancies( x 100
18 months
Live Birth Rate
Time Frame: 18 months
/Number of live births/ Number of embryo transfers ) x 100
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post- surgical bleeding
Time Frame: 30 days
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
Time Frame: 30 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Carlo Public Hospital, Potenza, Italy

Investigators

  • Principal Investigator: Assunta Iuliano, Principal Investigator, San Carlo Public Hospital, Potenza, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 30, 2027

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 25, 2025

First Posted (Actual)

December 5, 2025

Study Record Updates

Last Update Posted (Actual)

December 5, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • San Carlo PH
  • Comitato Etico Unico Regionale (Other Identifier: San Carlo Public Hospital, Potenza-Italy)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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