NCT05780632

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 22, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

April 3, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

November 14, 2023

Status Verified

November 1, 2023

Enrollment Period

1.9 years

First QC Date

March 10, 2023

Last Update Submit

November 13, 2023

Conditions

Poor Response to Ovulation Induction

Keywords

ovarian stimulationIVFoocyteenvironmentalgorithm

Outcome Measures

Primary Outcomes (1)

  • number of mature competent oocytes

    quality of oocytes which ensures high fertilisation rate

    24 months

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

patients undergoing IVF treatment

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pronatal

Ostrava, Czechia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood, follicular fluid, embryonic culture media

Study Officials

  • Jan Choma, MS

    Cognitive IVF

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Choma, MS

CONTACT

00420 602 575 666jan.choma@leeaf.life

Olga Chabr Grillova, MS

CONTACT

00420 602 564 062olga.grillova@leeaf.life

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2023

First Posted

March 22, 2023

Study Start

April 3, 2023

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

November 14, 2023

Record last verified: 2023-11

Locations

CZ(1)