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The Correlation Between Immunological Reaction of the Seminal Fluid in the Mother's Blood and Pregnancy Complications

NCT04314518 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2022-05-05

No results posted yet for this study

Summary

It is known that if there isn't an efficient exposure to the paternal antigens before conception, there is an increased risk for the pre-eclampsia (PE) cascade and other pregnancy complications to take place.

It is possible that maternal immune system that doesn't develop tolerance to the paternal antigens that the seminal fluid carries, doesn't developed an adequate immune tolerance to the trophoblast cells and due to that, they are being under greater attack during placentation. Thus, the cells don't go through a normal differentiation, don't perform normal pseudo-vasculogenesis and the PE cascade is more likely to be carried out.

Both the maternal immune system and the paternal alloantigens have a role in the development of PE. Although the specific etiology remains unclear and can be only hypothesized.

In this study the investigators aim is to try and prove that there is a difference in the immunological reactions to semen prior to conception and that these changes are related to PE and/or other obstetric complications.

Hence the investigators aim to study the immune response to semen of women that will be exposed to the culprit semen for the first time compare to women that have been exposed to a culprit semen more than once previously (namely more than 1 insemination prior to the time of evaluation). After that, in a prospective cohort study the investigators would follow those women through their pregnancies and check for different pregnancy outcomes.

In this manner, the investigators are hoping to create a screening tool that will help to predict pregnancy and fetal complications before conception related to maternal immune responses of paternal antigens.

Conditions

  • Preeclampsia
  • Pregnancy Complications
  • Insemination; Complication
  • Immune Tolerance
  • Paternal Exposure

Sponsors & Collaborators

  • Sheba Medical Center

    lead OTHER_GOV

Principal Investigators

  • Natav Hendin, Medical student · Sheba Medical Center

Eligibility

Min Age
18 Years
Max Age
46 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2023-12-01
Completion
2024-12-01

Countries

  • Israel

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04314518 on ClinicalTrials.gov