Uterine Interstitial Myolisis and Oocytes Retrieval in Single Step: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Chance of pregnancy after frozen embryotransfer
研究概览
简要总结
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:
- 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?
- 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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Infertile women with uterine fibroids who need to undergo oocytes retrieval between 18 and 45years old
排除标准
- •Fertile woman with uterine fibroids Fertile women without uterine fibroids Women under 18 years old Woman over 45 years old
结局指标
主要结局
Chance of pregnancy after frozen embryotransfer
时间窗: 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
时间窗: 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.
Post surgical pelvic organ injury
时间窗: 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
Live Birth Rate
时间窗: 18 months
/Number of live births/ Number of embryo transfers ) x 100
Pregnancy Rate
时间窗: 18 months after oocytes retrieval and interstitial myolysis
(Number of clinical pregnancies/ Number of embryo transfers) x 100
miscarriage rate
时间窗: 18 months
Number of miscarriages ( spntaneous abortions)/Number of clinicla pregnancies( x 100
次要结局
- Post- surgical bleeding(30 days)
- Post surgical sepsis(30 days)
研究者
Assunta Iuliano, MD
Medical Doctor
San Carlo Public Hospital, Potenza, Italy