CompletedNot Applicable

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

400 participantsStarted 2010-01-01

Plain-language summary

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.

Who can participate

Age range18 Years – 43 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Live birth rate (LBR)

Timeframe: 10 years

Abortion Rate (AR)

Timeframe: 10 years

Maternal complications rate

Timeframe: 10 years

Gestational age

Timeframe: 10 years

Prematurity rate

Timeframe: 10 years

Birth weight

Timeframe: 10 years

Sex ratio

Timeframe: 10 years

1- and 5-min APGAR

Timeframe: 10 years

Incidence of congenital defects

Timeframe: 10 years

Trial details

NCT IDNCT04852237

SponsorIstituto Clinico Humanitas

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-12-31

View on ClinicalTrials.gov More Obstructive Azoospermia trials