Poor Response to Ovulation InductionNAITIVENCT05780632
A Prospective Observational Study of Biomarkers for a Personalised IVF Treatment
An observational study of Poor Response to Ovulation Induction, run by Cognitive IVF a.s. at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Poor Response to Ovulation Induction
- How many people
- 500 participants
- Where
- 1 siteCzechia
- Study dates
- 3 Apr 2023to Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: patients undergoing IVF treatment
Who may be able to join
- women aged 18-45 accompanied by a male partner;
- diagnosis of infertility: one year of unprotected intercourse for patients under the age of 35; 6 months for patients aged 35 and older;
- embryo transfer planned using fresh, autologous oocytes;
- 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).
Who cannot join
- history of cancer or use of chemotherapeutic agents;
- history of autoimmune disease (apart from thyroid disease);
- known genetic conditions or balanced translocations causing disease or risk of disease which may require pre-implantation genetic testing;
- use of donated oocytes;
- stimulation protocols without polycystic ovary syndrome analogues.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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)
- Heart rate
- Respiratory rate
- Heart rate variability
- Blood oxygen level
- Sleeping cycle
- Sleeping respiratory rate
- Body temperature
- Activity - steps
- Stress level
Stream three: Environment
Based on patient location(s), the following data are monitored:
- Season
- Weather
- Moon phases
- Sun activity
- 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)
- anti-mullerian hormone
- follicle stimulating hormone
- luteinizing hormone (also on the trigger day)
- Oestradiol (also on the trigger day)
- Prolactin
- Progesterone (also on the trigger day)
- thyroid-stimulating hormone (TSH)
- antibody thyroid peroxidase
- sex hormone-binding globulin
- Testosterone
- DHEAS
Follicular fluid (FF)
- Examination of oxidative stress level a. Total oxidant status, Appendix 14 b. Total antioxidant capacity, Appendix 14
- Proteomic analysis, Appendix 15
- Amino acids analysis, Appendix 15
- Lipidaemic analysis, Appendix 15
- Metabolomic analysis, Appendix 15
Cumulus cells (CCs) a) Telomere length and telomere activity analysis, cell viability score, Appendix 16
Embryonic culture media (ECM)
- 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
- Polymorphisms of gene receptors influencing the response to ovarian stimulation by Next-Generation Sequencing (NGS) a. follicle-stimulating hormone receptor
- Gene polymorphisms in polycystic ovary syndrome patients a. CYP11A1 b. CYP17A1 c. CYP19A1
- Conditions
- Poor Response to Ovulation Induction
- Keywords
- ovarian stimulation, IVF, oocyte, environment, algorithm
What is being measured
The primary outcome is the main question the study is designed to answer.
number of mature competent oocytes
quality of oocytes which ensures high fertilisation rate
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start3 Apr 2023
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poor Response to Ovulation InductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cognitive IVF a.s.
- Sponsor type
- University, hospital or other
- Collaborators
- Brno University Hospital, Hospital General Universitario Morales Meseguer, Gynem, Pronatal, Szentagothai research centre, University of Pecs
- Responsible party
- Sponsor
- Investigators
- Jan Choma, MS, Principal investigator, Cognitive IVF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05780632
- Sponsor's protocol ID
- LEEAF10032023
- Acronym
- NAITIVE
- Status last verified
- Nov 2023
- First submitted
- 10 Mar 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study of Biomarkers for a Personalised IVF Treatment,
- ClinicalTrials.gov ID
- NCT05780632
- Acronym / sponsor ID
- NAITIVE / LEEAF10032023
- Conditions
- Poor Response to Ovulation Induction
- Keywords
- ovarian stimulation, IVF, oocyte, environment, algorithm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Cognitive IVF a.s.University, hospital or other
- Collaborators
- Brno University Hospital, Hospital General Universitario Morales Meseguer, Gynem, Pronatal, Szentagothai research centre, University of Pecs
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 22 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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)
- Heart rate
- Respiratory rate
- Heart rate variability
- Blood oxygen level
- Sleeping cycle
- Sleeping respiratory rate
- Body temperature
- Activity - steps
- Stress level
Stream three: Environment
Based on patient location(s), the following data are monitored:
- Season
- Weather
- Moon phases
- Sun activity
- 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)
- anti-mullerian hormone
- follicle stimulating hormone
- luteinizing hormone (also on the trigger day)
- Oestradiol (also on the trigger day)
- Prolactin
- Progesterone (also on the trigger day)
- thyroid-stimulating hormone (TSH)
- antibody thyroid peroxidase
- sex hormone-binding globulin
- Testosterone
- DHEAS
Follicular fluid (FF)
- Examination of oxidative stress level a. Total oxidant status, Appendix 14 b. Total antioxidant capacity, Appendix 14
- Proteomic analysis, Appendix 15
- Amino acids analysis, Appendix 15
- Lipidaemic analysis, Appendix 15
- Metabolomic analysis, Appendix 15
Cumulus cells (CCs) a) Telomere length and telomere activity analysis, cell viability score, Appendix 16
Embryonic culture media (ECM)
- 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
- Polymorphisms of gene receptors influencing the response to ovarian stimulation by Next-Generation Sequencing (NGS) a. follicle-stimulating hormone receptor
- Gene polymorphisms in polycystic ovary syndrome patients a. CYP11A1 b. CYP17A1 c. CYP19A1
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patients undergoing IVF treatment
Key inclusion criteria (4 listed)
- women aged 18-45 accompanied by a male partner;
- diagnosis of infertility: one year of unprotected intercourse for patients under the age of 35; 6 months for patients aged 35 and older;
- embryo transfer planned using fresh, autologous oocytes;
- 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).
Key exclusion criteria (5 listed)
- history of cancer or use of chemotherapeutic agents;
- history of autoimmune disease (apart from thyroid disease);
- known genetic conditions or balanced translocations causing disease or risk of disease which may require pre-implantation genetic testing;
- use of donated oocytes;
- stimulation protocols without polycystic ovary syndrome analogues.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
number of mature competent oocytes
Time frame: 24 months
quality of oocytes which ensures high fertilisation rate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
Related trials for Poor Response to Ovulation Induction
RecruitingPhase 2/3
Autologous Platelet Rich Plasma Intraovarian Infusion for Poor Responders
Poor Response to Ovulation Induction, Infertility, Female
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Choma, MS principal investigator
Cognitive IVF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Poor Response to Ovulation Induction, run by Cognitive IVF a.s. at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan Choma, MS (00420 602 575 666, jan.choma@leeaf.life), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of mature competent oocytes (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.