Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT05780632
Status:
UNKNOWN
Last Update Posted:
2023-11-14
First Post:
2023-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Prospective Observational Study of Biomarkers for a Personalised IVF Treatment
Sponsor:
Cognitive IVF a.s.
Organization:
Study Overview
Official Title:
A Prospective Observational Study of Biomarkers for a Personalised IVF Treatment,
Status:
UNKNOWN
Status Verified Date:
2023-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NAITIVE
Brief Summary:
Study investigates the effect of four-dimensional patient data (medical, lifestyle, environmental, and genetic) on the outcomes of ovarian stimulation for IVF.
Study will allow us to create a meaningful combination of medical knowledge, unique physician experience and information derived from data analysis. Additionally, the Study allows us to fine-tune the existing algorithms and develop new decision-supporting algorithms.
Study will allow us to create a meaningful combination of medical knowledge, unique physician experience and information derived from data analysis. Additionally, the Study allows us to fine-tune the existing algorithms and develop new decision-supporting algorithms.
Detailed Description:
Details of the ovarian stimulation and its outcomes for each patient will be analysed with the corresponding patient data collected or generated during the Study in the five streams as described under the headings "Stream one" to "Stream five".
Stream one: Personal and medical data Patient mobile app - collects up to 227 different data points about the female and additional up to 64 data points about her partner, Appendix 13.
Physician portal - mirrors the patient data from the mobile app and will provide tools for physician decision-making support and for error minimisation during the treatment using algorithms.
Stream two: Biorhythms and lifestyle Devices monitoring activity and health data (smart watches, bracelets, rings)
1. Heart rate
2. Respiratory rate
3. Heart rate variability
4. Blood oxygen level
5. Sleeping cycle
6. Sleeping respiratory rate
7. Body temperature
8. Activity - steps
9. Stress level
Stream three: Environment
Based on patient location(s), the following data are monitored:
1. Season
2. Weather
3. Moon phases
4. Sun activity
5. Pollution
Stream four: Biomarkers Blood tests - the hormonal profile is determined at the beginning of the menstrual cycle and some determinations are made on the day of ovulation induction (trigger)
1. anti-mullerian hormone
2. follicle stimulating hormone
3. luteinizing hormone (also on the trigger day)
4. Oestradiol (also on the trigger day)
5. Prolactin
6. Progesterone (also on the trigger day)
7. thyroid-stimulating hormone (TSH)
8. antibody thyroid peroxidase
9. sex hormone-binding globulin
10. Testosterone
11. DHEAS
Follicular fluid (FF)
1. Examination of oxidative stress level a. Total oxidant status, Appendix 14 b. Total antioxidant capacity, Appendix 14
2. Proteomic analysis, Appendix 15
3. Amino acids analysis, Appendix 15
4. Lipidaemic analysis, Appendix 15
5. Metabolomic analysis, Appendix 15
Cumulus cells (CCs) a) Telomere length and telomere activity analysis, cell viability score, Appendix 16
Embryonic culture media (ECM)
a) Embryonic DNA analysis by Next Generation Sequencing (NGS), Appendix 17 b) Embryonic microRNA analysis, Appendix 17 Stream five: Genetic study of FSH-receptor and polycystic ovary syndrome polymorphisms
1. Polymorphisms of gene receptors influencing the response to ovarian stimulation by Next-Generation Sequencing (NGS) a. follicle-stimulating hormone receptor
2. Gene polymorphisms in polycystic ovary syndrome patients a. CYP11A1 b. CYP17A1 c. CYP19A1
Stream one: Personal and medical data Patient mobile app - collects up to 227 different data points about the female and additional up to 64 data points about her partner, Appendix 13.
Physician portal - mirrors the patient data from the mobile app and will provide tools for physician decision-making support and for error minimisation during the treatment using algorithms.
Stream two: Biorhythms and lifestyle Devices monitoring activity and health data (smart watches, bracelets, rings)
1. Heart rate
2. Respiratory rate
3. Heart rate variability
4. Blood oxygen level
5. Sleeping cycle
6. Sleeping respiratory rate
7. Body temperature
8. Activity - steps
9. Stress level
Stream three: Environment
Based on patient location(s), the following data are monitored:
1. Season
2. Weather
3. Moon phases
4. Sun activity
5. Pollution
Stream four: Biomarkers Blood tests - the hormonal profile is determined at the beginning of the menstrual cycle and some determinations are made on the day of ovulation induction (trigger)
1. anti-mullerian hormone
2. follicle stimulating hormone
3. luteinizing hormone (also on the trigger day)
4. Oestradiol (also on the trigger day)
5. Prolactin
6. Progesterone (also on the trigger day)
7. thyroid-stimulating hormone (TSH)
8. antibody thyroid peroxidase
9. sex hormone-binding globulin
10. Testosterone
11. DHEAS
Follicular fluid (FF)
1. Examination of oxidative stress level a. Total oxidant status, Appendix 14 b. Total antioxidant capacity, Appendix 14
2. Proteomic analysis, Appendix 15
3. Amino acids analysis, Appendix 15
4. Lipidaemic analysis, Appendix 15
5. Metabolomic analysis, Appendix 15
Cumulus cells (CCs) a) Telomere length and telomere activity analysis, cell viability score, Appendix 16
Embryonic culture media (ECM)
a) Embryonic DNA analysis by Next Generation Sequencing (NGS), Appendix 17 b) Embryonic microRNA analysis, Appendix 17 Stream five: Genetic study of FSH-receptor and polycystic ovary syndrome polymorphisms
1. Polymorphisms of gene receptors influencing the response to ovarian stimulation by Next-Generation Sequencing (NGS) a. follicle-stimulating hormone receptor
2. Gene polymorphisms in polycystic ovary syndrome patients a. CYP11A1 b. CYP17A1 c. CYP19A1
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: