Infertility (IVF Patients)NCT06609421
Egg Quality Assessment
An observational study of Infertility (IVF Patients) and Ovarian Aging, run by Ovom Care GmbH at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Infertility (IVF Patients), Ovarian Aging, IVF
- What is being tested?
- Informative Appointment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Oct 2024to 1 Feb 2027
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Undergoing in vitro fertilisation treatment or egg freezing
Who cannot join
- No discarded, unfertilised eggs for collection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Infertility (IVF Patients), Ovarian Aging, IVF
- Being tested
- Informative Appointment
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Informative AppointmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Women undergoing in-vitro fertilisation (IVF) with male factor diagnoses. Receives: Other: Informative Appointment | |
| Case Group | Women undergoing IVF with a diagnosis other than male factor. Receives: Other: Informative Appointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mitochondrial physiology in the oocytes
Measured: Baseline time of observation which lasts between 1 and 5 hours
Secondary outcomes (1)
Comparison of oocyte mitochondrial physiology results to clinical outcomes to assess correlation (or lack thereof)
Measured: As the data becomes available over the course of the participants' medical treatment. E.g. From enrolment until birth of an infant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start9 Oct 2024
- Primary completion8 Nov 2024
- Study completion1 Feb 2027 (estimated)
Why it stopped: End of collaboration with research site.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infertility (IVF Patients)Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ovom Care GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609421
- Sponsor's protocol ID
- 340652
- Status last verified
- Jan 2025
- First submitted
- 22 Sep 2024
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Brayboy LM, Oulhen N, Witmyer J, Robins J, Carson S, Wessel GM. Multidrug-resistant transport activity protects oocytes from chemotherapeutic agents and changes during oocyte maturation. Fertil Steril. 2013 Nov;100(5):1428-35. doi: 10.1016/j.fertnstert.2013.07.002. Epub 2013 Aug 13.
PubMed 23953328
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Cohort Study of Oocyte Physiology in Discarded Samples of Patients Undergoing IVF
- ClinicalTrials.gov ID
- NCT06609421
- Acronym / sponsor ID
- 340652
- Conditions
- Infertility (IVF Patients), Ovarian Aging, IVF
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: End of collaboration with research site.
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ovom Care GmbHUniversity, hospital or other
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- 8 Nov 2024 (actual)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 24 Sep 2024 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | Other: Informative AppointmentWomen undergoing in-vitro fertilisation (IVF) with male factor diagnoses. |
| Case Group | – | Other: Informative AppointmentWomen undergoing IVF with a diagnosis other than male factor. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Undergoing in vitro fertilisation treatment or egg freezing
Key exclusion criteria (1 listed)
- No discarded, unfertilised eggs for collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Informative AppointmentThe 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. | Other | Case Group, Control Group |
Primary outcome
Mitochondrial physiology in the oocytes
Time frame: Baseline time of observation which lasts between 1 and 5 hours
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Background: PubMed 23953328Brayboy LM, Oulhen N, Witmyer J, Robins J, Carson S, Wessel GM. Multidrug-resistant transport activity protects oocytes from chemotherapeutic agents and changes during oocyte maturation. Fertil Steril. 2013 Nov;100(5):1428-35. doi: 10.1016/j.fertnstert.2013.07.002. Epub 2013 Aug 13.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Infertility (IVF Patients) and Ovarian Aging, run by Ovom Care GmbH at 1 site in United Kingdom.
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 1 inclusion and 1 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: paused, as of the sponsor's last update on 4 Feb 2025. 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 United Kingdom. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mitochondrial physiology in the oocytes (time frame: Baseline time of observation which lasts between 1 and 5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06609421, which also lists 1 linked publication.
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 4 Feb 2025.