Uterine Interstitial Myolisis and Oocytes Retrieval in Single Step: a Pilot Study
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorSan Carlo Public Hospital, Potenza, Italy
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
20 Participants
are grouped into 1 trial groupGroup A: infertile patients undergoing oocyte retrieval affected by uterine myomatosis
Trial outcomes
Primary outcomes
1
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.
Time frame
From the transfer of the thawed blastocyst to the birth of the baby. 18 months2
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.
Time frame
18 month3
Pregnancy Rate
(Number of clinical pregnancies/ Number of embryo transfers) x 100
Time frame
18 months after oocytes retrieval and interstitial myolysis4
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
Time frame
30 daysSecondary outcomes
1
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
Time frame
30 days2
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
Time frame
30 daysSponsors and contacts
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Source ClinicalTrials.gov
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