Clinical Pregnancy Rate, Live Birth Rate, Pregnancy Rate IVF
Conditions
Keywords
Oocyte retrieval, Interstitial myolysis, Assisted Reproductive Technology
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. 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
Interventions
None listed
Sponsors
San Carlo Public Hospital, Potenza, Italy
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chance of pregnancy after frozen embryotransfer | 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. |
| IVF/ICSI outcome | 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. |
| Pregnancy Rate | 18 months after oocytes retrieval and interstitial myolysis | (Number of clinical pregnancies/ Number of embryo transfers) x 100 |
| Post surgical pelvic organ injury | 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 |
| miscarriage rate | 18 months | Number of miscarriages ( spntaneous abortions)/Number of clinicla pregnancies( x 100 |
| Live Birth Rate | 18 months | /Number of live births/ Number of embryo transfers ) x 100 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post- surgical bleeding | 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 |
| Post surgical sepsis | 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 |
Countries
Italy
Contacts
Primary ContactAssunta Iuliano, Principal Investigator
Backup ContactSergio C Schettini, Direttore di Dipartimento
Outcome results
None listed