Is the Lack of Prior Exposure to Sperm Antigens Associated With Worse Neonatal and Maternal Outcomes?

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Obstructive Azoospermia, Obstetric Complication

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for case arm: primary infertility diagnosis of obstructive azoospermia ICSI-TESE cycles Inclusion Criteria for control arm: primary infertility ICSI cycles with sperm from ejaculate Exclusion Criteria: pre-gestational hypertension pre-gestational diabetes

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 43 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnancies from ICSI-TESE cycles for obstructive azoospermia.<br>Pregnancies occurred between January 2010 and December 2019 at Humanitas Fertility Center after ICSI-TESE cycles for obstructive azoospermia. | |
| Pregnancies from ICSI cycles with ejaculated sperm.<br>Pregnancies occurred between January 2010 and December 2019 at Humanitas Fertility Center after ICSI cycles with ejaculated sperm. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth rate (LBR) | Rate of delivery of a living baby after at least 22 weeks of gestation | 10 years | 
| Abortion Rate (AR) | Proportion of clinical pregnancies who failed to continue beyond 22 weeks of gestation | 10 years | 
| Maternal complications rate | Incidence of the obstetric complications, such as pre-eclampsia, gestational hypertension and diabetes, placenta previa and placental abruption. | 10 years | 
| Gestational age | Mean gestational age of the pregnancies considered (written with both weeks and days; eg, 39 weeks and 0 days) | 10 years | 
| Prematurity rate | Rate of pregnancies lasted less than 37 weeks and 0 days | 10 years | 
| Birth weight | Mean birth weight of the neonates, written in grams. | 10 years | 
| Sex ratio | Ratio between males and females among the newborns | 10 years | 
| 1- and 5-min APGAR | Objective score of the condition of a baby after birth, at 1 and 5 minutes from the delivery (from 1 to 10 points). | 10 years | 
| Incidence of congenital defects | Incidence of congenital malformations, deformations and chromosomal abnormalities among the newborns of the study group (eg. clubfoot deformity, anorectal malformations, heart defects, ...) | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neonatal outcomes