Infertility, FemaleNCT04945265
Effects of Age and Infertility on Ovarian Granulosa Cell Function
An observational study of Infertility, Female and Infertility Unexplained, run by King's College London.
Trial summary
Infertility is a life changing disorder, affecting 1 in 7 couples within the UK. Treatment options pose a significant cost burden to both the NHS and patient when NHS-funded treatment options are exhausted. This highlights the need for refinements in clinical management strategies for this patient group. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Infertility, Female, Infertility Unexplained, Infertility of Tubal Origin
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Jul 2021to Jun 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
- Adult
Study population: Women undergoing routine IVF treatment as part of their clinical treatment plan.
Who may be able to join
- Any woman that is:
- fluent in English,
- capable of giving consent,
- reproductive age (between the ages of 18-45),
- is HIV and Hep A and Hep B negative.
- undergoing IVF treatment for one of the following reasons:
Show all 14Show fewer
- unexplained infertility
- tubal disease
- egg freezing
- polycystic ovarian syndrome
- ovulatory disorders
- endometriosis
- male factor infertility
- any other cause of infertility such as fibroids.
Who cannot join
- Adults unable to consent for themselves,
- Non-fluent English speakers, unless in clinic translators are available
- Aged less than 18
- Is HIV or Hep A or B positive, or has not undergone screening.
About this study
Official title: Mechanistic Insight Into Ovarian Granulosa Cell Function Based on Age and Cause of Infertility
Infertility is a life changing disorder, affecting 1 in 7 couples within the UK. Treatment options pose a significant cost burden to both the NHS and patient when NHS-funded treatment options are exhausted. This highlights the need for refinements in clinical management strategies for this patient group. Although there have been advancements in assisted reproductive technologies, the success rates of techniques such as in vitro fertilization (IVF) remain low. Surprisingly, the IVF hormonal regimens used by most assisted conception units fail to take account of patient age, ovarian reserve or cause of infertility when deciding on treatment regimen, with a 'one size fits all' approach to treatment. The investigators propose that age and cause of infertility modify the functions and environment provided by the cells (granulosa cells) that support egg (oocyte) growth and development and understanding these changes will allow for a more personalised approach to IVF treatment regimens. The aim of this study therefore is to recruit female patients undergoing IVF with different causes of infertility and age, and harvest granulosa cells from remaining material (follicular aspirates) generated at the time of egg retrieval. Granulosa cells will be cultured in vitro and cellular functions assessed. The investigators will also recruit female patients with normal fertility undergoing IVF procedure due to other reasons (i.e. egg freezing, diagnostics of genetic diseases on embryos).
- Keywords
- ovary, granulosa cells, infertility, ageing
- Medical subject headings
- Infertility, Female, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women aged <30 | Not described | |
| Women aged 30-36 | Not described | |
| Women aged 37-40 | Not described | |
| Women aged >40 | Not described | |
| Women undergoing egg freezing/male factor infertility/genetic testing | Not described | |
| unidentified cause of infertility | Not described | |
| PCOS | Not described | |
| endometriosis | Not described | |
| tubal disorders | Not described | |
| ovulatory disorders | Not described | |
| other causes of infertility e.g., fibroids. | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of hormone production, protein and RNA expression
Assessed via cellular signalling responses to endocrine stimulation, production of steroid hormones, protein analysis and RNA analysis
Measured: 0-14 days
Secondary outcomes (1)
Correlation of cellular responses with age and cause of infertility.
Assessed via statistical analysis
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study startJul 2021 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04945265
- Sponsor's protocol ID
- 264510
- Status last verified
- Jun 2021
- First submitted
- 25 Jun 2021
- Last updated
- 7 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanistic Insight Into Ovarian Granulosa Cell Function Based on Age and Cause of Infertility
- ClinicalTrials.gov ID
- NCT04945265
- Acronym / sponsor ID
- 264510
- Keywords
- ovary, granulosa cells, infertility, ageing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- Jul 2021 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 30 Jun 2021 (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.
Infertility is a life changing disorder, affecting 1 in 7 couples within the UK. Treatment options pose a significant cost burden to both the NHS and patient when NHS-funded treatment options are exhausted. This highlights the need for refinements in clinical management strategies for this patient group. Although there have been advancements in assisted reproductive technologies, the success rates of techniques such as in vitro fertilization (IVF) remain low. Surprisingly, the IVF hormonal regimens used by most assisted conception units fail to take account of patient age, ovarian reserve or cause of infertility when deciding on treatment regimen, with a 'one size fits all' approach to treatment. The investigators propose that age and cause of infertility modify the functions and environment provided by the cells (granulosa cells) that support egg (oocyte) growth and development and understanding these changes will allow for a more personalised approach to IVF treatment regimens. The aim of this study therefore is to recruit female patients undergoing IVF with different causes of infertility and age, and harvest granulosa cells from remaining material (follicular aspirates) generated at the time of egg retrieval. Granulosa cells will be cultured in vitro and cellular functions assessed. The investigators will also recruit female patients with normal fertility undergoing IVF procedure due to other reasons (i.e. egg freezing, diagnostics of genetic diseases on embryos).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Women aged <30 | – | – |
| Women aged 30-36 | – | – |
| Women aged 37-40 | – | – |
| Women aged >40 | – | – |
| Women undergoing egg freezing/male factor infertility/genetic testing | – | – |
| unidentified cause of infertility | – | – |
| PCOS | – | – |
| endometriosis | – | – |
| tubal disorders | – | – |
| ovulatory disorders | – | – |
| other causes of infertility e.g., fibroids. | – | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women undergoing routine IVF treatment as part of their clinical treatment plan.
Key inclusion criteria (14 listed)
- Any woman that is:
- fluent in English,
- capable of giving consent,
- reproductive age (between the ages of 18-45),
- is HIV and Hep A and Hep B negative.
Key exclusion criteria (4 listed)
- Adults unable to consent for themselves,
- Non-fluent English speakers, unless in clinic translators are available
- Aged less than 18
- Is HIV or Hep A or B positive, or has not undergone screening.
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
Assessment of hormone production, protein and RNA expression
Time frame: 0-14 days
Assessed via cellular signalling responses to endocrine stimulation, production of steroid hormones, protein analysis and RNA analysis
1 secondary outcome
Correlation of cellular responses with age and cause of infertility.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female and Infertility Unexplained, run by King's College London.
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 14 inclusion and 4 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 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Assessment of hormone production, protein and RNA expression (time frame: 0-14 days). 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 7 Jul 2021.