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

NCT ID: NCT04852237

Last Updated: 2021-04-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-01-01
• Study Completion Date: 2019-12-31

Brief 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.

Detailed Description

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.

Conditions

Obstructive Azoospermia; Obstetric Complication

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Pregnancies from ICSI-TESE cycles for obstructive azoospermia.

Pregnancies occurred between January 2010 and December 2019 at Humanitas Fertility Center after ICSI-TESE cycles for obstructive azoospermia.

No interventions assigned to this group

Pregnancies from ICSI cycles with ejaculated sperm.

Pregnancies occurred between January 2010 and December 2019 at Humanitas Fertility Center after ICSI cycles with ejaculated sperm.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• primary infertility
• diagnosis of obstructive azoospermia
• ICSI-TESE cycles

• primary infertility
• ICSI cycles with sperm from ejaculate

Exclusion Criteria

• pre-gestational hypertension
• pre-gestational diabetes

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 43 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Clinico Humanitas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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Other Identifiers

1916

Identifier Type: -

Identifier Source: org_study_id