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临床试验/NCT04894136
NCT04894136已完成不适用

Reproductive and Obstetric Outcomes in TESE-ICSI Cycles: a Comparison Between Obstructive and Non-obstructive Azoospermia

Istituto Clinico Humanitas0 个研究点目标入组 520 人开始时间: 2001年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
520
主要终点
Abortion rate

研究概览

简要总结

A comparison of reproductive and obstetrical outcomes is retrospectively performed among couples that underwent ICSI-TESE cycles for obstructive and non obstructive azoospermia between January 2001 and December 2019.

详细描述

Azoospermia affects almost 20% of all infertile males and It can be divided into obstructive azoospermia (OA) and nonobstructive azoospermia (NOA). Assisted fertilization with testicular sperm extraction (TESE) and intracytoplasmatic sperm injection (ICSI) has been successfully applied for its treatment.

Review of the literature shows that there is a lack of consensus about reproductive outcomes between men with OA and NOA. No study has ever investigated differences in obstetrical outcomes between these two groups before.

The objective of this study is to retrospectively determine differences in reproductive and obstetrical outcomes among couples that underwent ICSI-TESE cycles for obstructive and non obstructive azoospermia.

The primary outcomes that will be investigated include:

  • Reproductive outcomes: pregnancy rate, live birth rate (LBR) and abortion rate.
  • Obstetrical outcomes: twinning rate, gestational age, prematurity rate, birth weight, cesarean section rate and the rate of the main obstetrical complication, such as pre-eclampsia, gestational hypertension, intrauterine growth restriction (IUGR).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Sperm donation
  • Use of ejaculated sperm
  • Couples who underwent pre-implantation genetic testing

结局指标

主要结局

Abortion rate

时间窗: 20 years (2001-2019)

Proportion of clinical pregnancies who failed to continue beyond 22 weeks of gestation

Live birth rate (LBR)

时间窗: 20 years (2001-2019)

Rate of delivery of a living baby after at least 22 weeks of gestation

Pregnancy rate

时间窗: 20 years (2001-2019)

Total number of pregnancies including live births, abortions and fetal death

Gestational age

时间窗: 20 years (2001-2019)

Mean gestational age of the pregnancies considered (written with both weeks and days)

Maternal complications rate

时间窗: 20 years (2001-2019)

Incidence of the obstetric complications, such as pre-eclampsia, gestational hypertension, placenta previa and placental abruption, intrauterine growth restriction.

Twinning rate

时间窗: 20 years (2001-2019)

Rate of twin deliveries out of the total number of deliveries

Cesarean section rate

时间窗: 20 years (2001-2019)

Rate of cesarean section deliveries out of the total number of deliveries

Prematurity rate

时间窗: 20 years (2001-2019)

Rate of pregnancies lasted less than 37 weeks and 0 days

Birth weight

时间窗: 20 years (2001-2019)

Mean birth weight of the neonates written in grams.

次要结局

未报告次要终点

研究者

发起方
Istituto Clinico Humanitas
申办方类型
Other
责任方
Sponsor

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