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NCT Number: NCT04852237

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

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.

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Key information

Conditions

Obstructive Azoospermia Obstetric Complication

Age range

18 year–43 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Live birth rate (LBR)

    Time frame: 10 years

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

  2. Abortion Rate (AR)

    Time frame: 10 years

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

  3. Maternal complications rate

    Time frame: 10 years

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

  4. Gestational age

    Time frame: 10 years

    Mean gestational age of the pregnancies considered (written with both weeks and days; eg, 39 weeks and 0 days)

  5. Prematurity rate

    Time frame: 10 years

    Rate of pregnancies lasted less than 37 weeks and 0 days

  6. Birth weight

    Time frame: 10 years

    Mean birth weight of the neonates, written in grams.

  7. Sex ratio

    Time frame: 10 years

    Ratio between males and females among the newborns

  8. 1- and 5-min APGAR

    Time frame: 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).

  9. Incidence of congenital defects

    Time frame: 10 years

    Incidence of congenital malformations, deformations and chromosomal abnormalities among the newborns of the study group (eg. clubfoot deformity, anorectal malformations, heart defects, ...)

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2019
Study completion
2019
First posted
Apr 21, 2021
Registry last updated
Apr 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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