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ENROLLING BY INVITATION
NCT06709976

ReceptIVFity & Immunology in ART

Sponsor: Erasmus Medical Center

View on ClinicalTrials.gov

Summary

The goal of this clinical non-invasive observational pilot study is to improve the prediction of pregnancy success after In Vitro Fertilisation (IVF)/IVF -Intracytoplasmic Sperm Injection (ICSI) treatment by examining the vaginal microbiome and the immunological profile of menstrual blood in women (18-42) years old) undergoing their first IVF/IVF/ICSI treatment. The main questions it aims to answer are: What is the ReceptIVFity profile (low, medium, or high) of the vaginal microbiome in these women? How do the endometrial-derived lymphocytes respond to different immune stimuli and microbiota? Can the endometrial stromal cells decidualize effectively in the presence or absence of specific microbiota? Participants will: Self-perform a vaginal swab to determine the ReceptIVFity profile of their vaginal microbiome. Self-collect menstrual blood during 24 hours in 2 blocks of 12 hours for immunological analysis.

Official title: Increasing the Accuracy to Predict Pregnancy Success After Assisted Reproductive Therapy (ART) by Combining the ReceptIVFIty Test with Immunological Parameters

Key Details

Gender

FEMALE

Age Range

18 Years - 42 Years

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2024-09-06

Completion Date

2025-12-01

Last Updated

2024-12-09

Healthy Volunteers

Yes

Interventions

DEVICE

Vaginal microbiome swab

All swabs were collected using FLOQSwabs™ (Copan Italia SpA, Brescia, Italy). The patients were instructed to spread the labia with one hand, insert the swab 3-5 cm beyond the vaginal orifice with the other hand, and rotate the swab along the vaginal wall for 10-15 seconds.

DEVICE

Menstrual Blood Collection via Menstrual Cup

Self-collect menstrual blood during 24 hours in 2 blocks of 12 hours

Locations (1)

Erasmus Medical Center

Rotterdam, South Holland, Netherlands