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Effects of Age and Infertility on Ovarian Granulosa Cell Function

Mechanistic Insight Into Ovarian Granulosa Cell Function Based on Age and Cause of Infertility

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04945265
Enrollment
500
Registered
2021-06-30
Start date
2021-07-31
Completion date
2025-06-30
Last updated
2021-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Infertility, Female, Infertility of Tubal Origin, Infertility Unexplained

Keywords

ovary, granulosa cells, infertility, ageing

Brief 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. 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).

Interventions

None listed

Sponsors

King's College London
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years

Inclusion criteria

* 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: 1. unexplained infertility 2. tubal disease 3. egg freezing 4. polycystic ovarian syndrome 5. ovulatory disorders 6. endometriosis 7. male factor infertility 8. any other cause of infertility such as fibroids.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Assessment of hormone production, protein and RNA expression0-14 daysAssessed via cellular signalling responses to endocrine stimulation, production of steroid hormones, protein analysis and RNA analysis

Secondary

MeasureTime frameDescription
Correlation of cellular responses with age and cause of infertility.12 monthsAssessed via statistical analysis

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026