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

NCT04314518 | Unknown

• 1 other identifier: SHEBA-19-6226-NH-CTIL
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Preeclampsia; Artificial insemination; Seminal fluid; Maternal immune tolerance; Trophoblast; Vasculogenesis; Placentation; NK cells; T cells; Skin prick test

Outcome Measures

Primary Outcomes (1)

• Pregnancy complications

  Pregnancy complications including PE, placental abruption, IUGR

  2 years (Anticipated)

Secondary Outcomes (1)

• Other pregnancy complications (Clinical or sonographic)

  2 years (Anticipated)

Eligibility Criteria

• Age: 18 Years - 46 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Following immunological evaluation (as specified in sec. 3) we will prospectively follow the patients and record pregnancy outcomes. Women (from each group) will be divided into 2 sub-groups: 1. PE pregnancies and other pregnancy complications 2. Normal pregnancies In the end, we will compare between the groups and the immunology reactions at the beginning of the follow-up and see if there is a difference that is statistically significant based on the immunological results. * Women that are going through artificial insemination attend in routine follow ups in Sheba medical center that will allow continuation of follow up after the course of pregnancy. * Woman recruited to participate in the study will be marked as such by a "pop up" message appearing on their computerized medical file.

You may qualify if:

• Age 18-45
• women for each group.
• Primigravid or first insemination from a new partner/sperm donor (group I)
• Women exposed to sperm (from the same donor/partner ≥ 2 times) (Group II)
• Singleton gestation
• Obtained verbal/written consent to participate in study

You may not qualify if:

• o Multiple gestation
• Multifetal gestation
• Chronic hypertension
• Chronic renal disease
• Autoimmune disease (antiphospholipid syndrome, systemic lupus erythematosus)
• Vascular disease
• Pregestational diabetes mellitus

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (2)

Sheba medical center

Ramat Gan, Israel

NOT YET RECRUITING

Tel Hashomer Hospital

Ramat Gan, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

After enrollment, Seminal fluid sample will be extracted from the sperm sample of the donor at the sperm bank of Sheba medical center. After enrollment and in close proximity to the artificial insemination each woman will donate blood samples.

MeSH Terms

Conditions

Pre-Eclampsia; Pregnancy Complications

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Natav Hendin, Medical student

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

‪Natav Hendin‬, Medical student

CONTACT

0546899506; hendinatav@gmail.com

Raanan Meir, OBG-YN Physician

CONTACT

0528643339; raananmeir@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2020
• First Posted: March 19, 2020
• Study Start: November 1, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: May 5, 2022

Record last verified: 2021-09

Locations

IL (2)