Is the Lack of Prior Exposure to Sperm Antigens Associated With Worse Neonatal and Maternal Outcomes? A 10 Years Single-center Experience Comparing ICSI-TESE Pregnancies From ICSI Pregnancies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 主要终点
- Prematurity rate
研究概览
简要总结
The objective of this study is to determine if the lack of exposure to sperm antigens is associated with worse maternal and neonatal outcomes in pregnancies obtained after ICSI (intracytoplasmic sperm injection)-TESE (testicular sperm extraction) for obstructive azoospermia.
The primary outcomes that will be investigated include:
- Maternal outcomes: live birth rate (LBR), abortion rate, and the rate of the main obstetrics complication, such as pre-eclampsia, gestational hypertension and diabetes mellitus.
- Neonatal outcomes: gestational age, prematurity rate, birth weight, sex ratio, 1- and 5-min APGAR, birth defects.
详细描述
Several studies investigated the role of paternal factors in the development of preeclampsia; in particular, they analyzed the correlation between the vaginal exposure to male partner's semen and the incidence of preeclampsia, observing both a reduced risk of preeclampsia after prolonged exposure to the paternal seminal fluid and a higher incidence of preeclampsia in pregnancies conceived with a new father or with sperm donor. This leads to the hypothesis of an immunological role for sperm in inducing a mucosal immune tolerance-like status at the level of the uterus that could be critical in the subsequent implantation.
Previous studies also examined the neonatal outcomes from pregnancies obtained from surgically retrieved sperm, either epididymal or testicular sperm, and underlined that there is not overall increased risk in neonatal outcomes.
Our study aims at having a complete view on paternal, maternal and neonatal information and a follow up, that allows to correct possible confounders and to analyze a wider group of outcomes.
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 43 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •pre-gestational hypertension
- •pre-gestational diabetes
结局指标
主要结局
Prematurity rate
时间窗: 10 years
Rate of pregnancies lasted less than 37 weeks and 0 days
Live birth rate (LBR)
时间窗: 10 years
Rate of delivery of a living baby after at least 22 weeks of gestation
Abortion Rate (AR)
时间窗: 10 years
Proportion of clinical pregnancies who failed to continue beyond 22 weeks of gestation
Birth weight
时间窗: 10 years
Mean birth weight of the neonates, written in grams.
Sex ratio
时间窗: 10 years
Ratio between males and females among the newborns
1- and 5-min APGAR
时间窗: 10 years
Objective score of the condition of a baby after birth, at 1 and 5 minutes from the delivery (from 1 to 10 points).
Maternal complications rate
时间窗: 10 years
Incidence of the obstetric complications, such as pre-eclampsia, gestational hypertension and diabetes, placenta previa and placental abruption.
Gestational age
时间窗: 10 years
Mean gestational age of the pregnancies considered (written with both weeks and days; eg, 39 weeks and 0 days)
Incidence of congenital defects
时间窗: 10 years
Incidence of congenital malformations, deformations and chromosomal abnormalities among the newborns of the study group (eg. clubfoot deformity, anorectal malformations, heart defects, ...)
次要结局
未报告次要终点