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

April 20, 2021 updated by: Istituto Clinico Humanitas

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 43 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Live birth rate (LBR)
Time Frame: 10 years
Rate of delivery of a living baby after at least 22 weeks of gestation
10 years
Abortion Rate (AR)
Time Frame: 10 years
Proportion of clinical pregnancies who failed to continue beyond 22 weeks of gestation
10 years
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.
10 years
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)
10 years
Prematurity rate
Time Frame: 10 years
Rate of pregnancies lasted less than 37 weeks and 0 days
10 years
Birth weight
Time Frame: 10 years
Mean birth weight of the neonates, written in grams.
10 years
Sex ratio
Time Frame: 10 years
Ratio between males and females among the newborns
10 years
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).
10 years
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, ...)
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istituto Clinico Humanitas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 30, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1916

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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