Trials / Enrolling By Invitation
Enrolling By InvitationNCT06709976
ReceptIVFity & Immunology in ART
Increasing the Accuracy to Predict Pregnancy Success After Assisted Reproductive Therapy (ART) by Combining the ReceptIVFIty Test with Immunological Parameters
- Status
- Enrolling By Invitation
- Phase
- —
- Study type
- Observational
- Enrollment
- 50 (estimated)
- Sponsor
- Erasmus Medical Center · Academic / Other
- Sex
- Female
- Age
- 18 Years – 42 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2024-09-06
- Primary completion
- 2025-08-01
- Completion
- 2025-12-01
- First posted
- 2024-11-29
- Last updated
- 2024-12-09
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT06709976. Inclusion in this directory is not an endorsement.