Egg Quality Assessment

January 31, 2025 updated by: Ovom Care GmbH

Observational Cohort Study of Oocyte Physiology in Discarded Samples of Patients Undergoing IVF

The goal of this observational study is to learn about egg physiology in humans.

The main question it aims to answer is if there is an association between egg physiology and egg quality.

Discarded, unfertilised eggs and follicular fluid collected during routine egg retrieval from participants undergoing in vitro fertilisation (IVF) as part of their regular medical care along with information from participants' electronic medical records will be collected and analysed.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

People with uteri experiencing infertility issues requiring assisted reproduction via in vitro fertilisation (IVF)/intracytoplasmic sperm injection (ICSI) or undergoing elective egg freezing.

Description

Inclusion Criteria:

  • Undergoing in vitro fertilisation treatment or egg freezing

Exclusion Criteria:

  • No discarded, unfertilised eggs for collection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control Group
Women undergoing in-vitro fertilisation (IVF) with male factor diagnoses.
Other: Informative Appointment
The only intervention involving the participants is non-clinical, which is an extra 30-minute informative telephone appointment added to the standard care consultation schedule of interested IVF patients where they will be presented with a digital consent PDF form to sign by a study nurse or clinically trained research personnel. Participants will be in the study for 24-30 months. During this time their discarded, unfertilised oocytes and follicular fluid collected during routine oocyte retrieval along with information from their electronic medical records will be collected and analysed.
Case Group
Women undergoing IVF with a diagnosis other than male factor.
Other: Informative Appointment
The only intervention involving the participants is non-clinical, which is an extra 30-minute informative telephone appointment added to the standard care consultation schedule of interested IVF patients where they will be presented with a digital consent PDF form to sign by a study nurse or clinically trained research personnel. Participants will be in the study for 24-30 months. During this time their discarded, unfertilised oocytes and follicular fluid collected during routine oocyte retrieval along with information from their electronic medical records will be collected and analysed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mitochondrial physiology in the oocytes
Time Frame: Baseline time of observation which lasts between 1 and 5 hours
Baseline time of observation which lasts between 1 and 5 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of oocyte mitochondrial physiology results to clinical outcomes to assess correlation (or lack thereof)
Time Frame: As the data becomes available over the course of the participants' medical treatment. E.g. From enrolment until birth of an infant
As the data becomes available over the course of the participants' medical treatment. E.g. From enrolment until birth of an infant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ovom Care GmbH

Collaborators

Avenues Clinic

Investigators

  • Principal Investigator: Muhammad Fatum, Avenues Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2024

Primary Completion (Actual)

November 8, 2024

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

September 22, 2024

First Submitted That Met QC Criteria

September 22, 2024

First Posted (Actual)

September 24, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 31, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 340652

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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