A Prospective Observational Study of Biomarkers for a Personalised IVF Treatment

Poor Response to Ovulation Induction Clinical Trial

— NAITIVE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05780632
• Other study ID #: LEEAF10032023
• Status: Recruiting
• Start date: April 3, 2023
• Est. completion date: March 2025

Study information

• Verified date: November 2023
• Source: Cognitive IVF a.s.
• Contact: Jan Choma, MS
• Phone: 00420 602 575 666
• Email: jan.choma[@]leeaf.life
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Poor Response to Ovulation Induction

Locations

Country	Name	City	State
Czechia	Pronatal	Ostrava

Sponsors (7)

Lead Sponsor	Collaborator
Cognitive IVF a.s.	Brno University Hospital, Gynem, Hospital General Universitario Morales Meseguer, Pronatal, Szentagothai research centre, University of Pecs

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of mature competent oocytes	quality of oocytes which ensures high fertilisation rate	24 months