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NCT Number: NCT07267754

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

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

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Key information

Conditions

Pregnancy Rate IVF Clinical Pregnancy Rate Live Birth Rate

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

San Carlo Public Hospital, Potenza -Italy

Potenza, PZ, 85100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. Pregnancy Rate

    Time frame: 18 months after oocytes retrieval and interstitial myolysis

    (Number of clinical pregnancies/ Number of embryo transfers) x 100

  4. 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

  5. miscarriage rate

    Time frame: 18 months

    Number of miscarriages ( spntaneous abortions)/Number of clinicla pregnancies( x 100

  6. Live Birth Rate

    Time frame: 18 months

    /Number of live births/ Number of embryo transfers ) x 100

Secondary outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Assunta Iuliano, Principal Investigator

CONTACT

[email protected]

+393496330637 ext. +390971612241

Sergio C Schettini, Direttore di Dipartimento

CONTACT

[email protected]

+390971613156

Sponsors and collaborators

Lead sponsor

San Carlo Public Hospital, Potenza, Italy

Other

Registry information

Acronym: UIMandOPU

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 5, 2025
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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