A Prospective Observational Study of Biomarkers for a Personalised IVF Treatment (NAITIVE)

A Prospective Observational Study of Biomarkers for a Personalised IVF Treatment,

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 Overview

• Status: Recruiting
• Conditions: Poor Response to Ovulation Induction

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

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Jan Choma, MS; Phone Number: 00420 602 575 666; Email: jan.choma@leeaf.life
• Study Contact Backup: Name: Olga Chabr Grillova, MS; Phone Number: 00420 602 564 062; Email: olga.grillova@leeaf.life

Study Locations

• Czechia
  • Ostrava, Czechia
    • Recruiting
    • Pronatal
    • Contact: Ivana Oborna, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients undergoing IVF treatment

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of mature competent oocytes	quality of oocytes which ensures high fertilisation rate	24 months

Collaborators and Investigators

• Sponsor: Cognitive IVF a.s.
• Collaborators: University of Pecs; Brno University Hospital; Hospital General Universitario Morales Meseguer; Gynem; Pronatal; Szentagothai research centre
• Investigators: Principal Investigator: Jan Choma, MS, Cognitive IVF

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2023
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: March 10, 2023
• First Submitted That Met QC Criteria: March 10, 2023
• First Posted (Actual): March 22, 2023

Study Record Updates

• Last Update Posted (Actual): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: IVF; algorithm; environment; ovarian stimulation; oocyte
• Other Study ID Numbers: LEEAF10032023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No