Test to predict pregnancy chances for IVF patients
Innovation for Small-scale Experiments: ReceptIVFity Test
This study is testing a new way to predict the chances of getting pregnant through IVF by looking at the vaginal bacteria in women aged 18 to 43.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 683 (estimated) |
| Ages | 18 Years to 42 Years |
| Sex | Female |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 1 site (Rotterdam) |
| Trial ID | NCT06051201 on ClinicalTrials.gov |
What this trial studies
The ReceptIVFity test evaluates the vaginal microbiome to predict the success rate of IVF or IVF-ICSI treatments. This prospective, non-invasive randomized controlled study aims to compare Shared Decision Making with Physician Decision in determining the likelihood of successful pregnancies. It includes an observational arm for women of non-European origin and focuses on naïve IVF patients aged 18 to 43. The study seeks to reduce unnecessary treatment cycles and improve the efficacy of IVF procedures.
Who should consider this trial
Good fit: Ideal candidates are naïve IVF or IVF-ICSI patients aged 18 to 43 who are willing to provide a vaginal swab for the ReceptIVFity test.
Not a fit: Patients currently using hormonal contraceptives or antibiotics, or those requiring emergency IVF for cancer, will not benefit from this study.
Why it matters
Potential benefit: If successful, this test could enhance the chances of achieving pregnancy for IVF patients by providing tailored treatment recommendations.
How similar studies have performed: Other studies have shown promise in using microbiome assessments to improve IVF outcomes, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Naïve IVF or IVF/ICSI patients 2. Indication for an IVF or IVF-ICSI procedure. 3. 18 years \< age \< 43 years. 4. Willing to provide a vaginal swab with the ReceptIVFity test. 5. Willing to provide informed consent. Exclusion Criteria: 1. The use of hormonal contraceptives at the time of taking the test. 2. The use of antibiotic treatment at the time of taking the test. 3. Emergency IVF for cancer or other reasons. 4. Women with endometriosis pre-treated with an Gn-RH analogue. 5. Women having IVF for egg preservation reasons.
Where this trial is running
Rotterdam
- Erasmus University Medical Center — Rotterdam, Netherlands (Recruiting)
Study contacts
- Principal investigator: Sam Schoenmakers, Dr. drs. — Erasmus MC Rotterdam
- Study coordinator: Xu Shan Gao, drs.
- Email: guvastudie@erasmusmc.nl
- Phone: +31631016348
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.