Observing biomarkers for personalized IVF treatment
A Prospective Observational Study of Biomarkers for a Personalised IVF Treatment,
This study is trying to see if using a mobile app to gather personal health and lifestyle information can help improve IVF treatment outcomes for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Cognitive IVF a.s. Academic / other |
| Locations | 1 site (Ostrava) |
| Trial ID | NCT05780632 on ClinicalTrials.gov |
What this trial studies
This study investigates how a combination of medical, lifestyle, environmental, and genetic data affects ovarian stimulation outcomes in IVF. It utilizes a mobile app to collect extensive patient data and a physician portal to support decision-making. The study analyzes various factors, including biorhythms, environmental conditions, and hormonal profiles, to refine existing algorithms and develop new ones for better treatment outcomes. By integrating these diverse data streams, the study aims to enhance personalized treatment approaches for patients undergoing IVF.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-45 with a male partner, diagnosed with infertility and planning embryo transfer using their own oocytes.
Not a fit: Patients with a history of cancer, autoimmune diseases, or those using donated oocytes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and personalized IVF treatments, improving success rates for patients.
How similar studies have performed: While the integration of diverse data streams in IVF is innovative, similar studies have shown promise in enhancing treatment personalization, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. women aged 18-45 accompanied by a male partner; 2. diagnosis of infertility: one year of unprotected intercourse for patients under the age of 35; 6 months for patients aged 35 and older; 3. embryo transfer planned using fresh, autologous oocytes; 4. using the Oura Ring smart device and sharing health and lifestyle data through the device at least during the IVF treatment (from the beginning of ovarian stimulation until the pregnancy test). Exclusion Criteria: 1. history of cancer or use of chemotherapeutic agents; 2. history of autoimmune disease (apart from thyroid disease); 3. known genetic conditions or balanced translocations causing disease or risk of disease which may require pre-implantation genetic testing; 4. use of donated oocytes; 5. stimulation protocols without polycystic ovary syndrome analogues.
Where this trial is running
Ostrava
- Pronatal — Ostrava, Czechia (Recruiting)
Study contacts
- Principal investigator: Jan Choma, MS — Cognitive IVF
- Study coordinator: Jan Choma, MS
- Email: jan.choma@leeaf.life
- Phone: 00420 602 575 666
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.