An observational study in Obstructive Azoospermia and Obstetric Complication, sponsored by Istituto Clinico Humanitas. Completed. Open to participants aged 18 Years to 43 Years. Per ClinicalTrials.gov, last updated 2021-04-22.
Sponsored by Istituto Clinico Humanitas · Observational
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:
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.
59 studies on the registry are indexed under Azoospermia; 17 are open to participants now.
This study's enrollment of 400 is above the median of 95 across 24 observational studies indexed under Azoospermia.
Browse Azoospermia studies →Istituto Clinico Humanitas is the lead sponsor of 279 studies on the registry; 70 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study database will include all the pregnancies occurred between January 2010 and December 2019 at Humanitas Fertility Center after ICSI-TESE cycles for obstructive azoospermia.
A comparison of maternal and neonatal outcomes will be performed among the above-mentioned pregnancies and pregnancies from ICSI cycles with ejaculated sperm of couples with different indications occurred in the same period of time.
The controls will be matched to the cases for the principal risk factors for adverse maternal and neonatal outcomes (maternal age, BMI) with a ratio of 1:2.
Inclusion Criteria for case arm:
Inclusion Criteria for control arm:
Exclusion Criteria:
Pregnancies occurred between January 2010 and December 2019 at Humanitas Fertility Center after ICSI-TESE cycles for obstructive azoospermia.
Pregnancies occurred between January 2010 and December 2019 at Humanitas Fertility Center after ICSI cycles with ejaculated sperm.
Live birth rate (LBR)
Rate of delivery of a living baby after at least 22 weeks of gestation
Time frame: 10 years
Abortion Rate (AR)
Proportion of clinical pregnancies who failed to continue beyond 22 weeks of gestation
Time frame: 10 years
Maternal complications rate
Incidence of the obstetric complications, such as pre-eclampsia, gestational hypertension and diabetes, placenta previa and placental abruption.
Time frame: 10 years
Gestational age
Mean gestational age of the pregnancies considered (written with both weeks and days; eg, 39 weeks and 0 days)
Time frame: 10 years
Prematurity rate
Rate of pregnancies lasted less than 37 weeks and 0 days
Time frame: 10 years
Birth weight
Mean birth weight of the neonates, written in grams.
Time frame: 10 years
Sex ratio
Ratio between males and females among the newborns
Time frame: 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).
Time frame: 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, ...)
Time frame: 10 years
No study locations are listed for this record.
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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