Clinical trial NCT04945265: Effects of Age and Infertility on Ovarian Granulosa Cell Function
Official title: Mechanistic Insight Into Ovarian Granulosa Cell Function Based on Age and Cause of Infertility
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility, Female
Infertility Unexplained
Infertility of Tubal Origin
Infertility
Keywords: ovary
granulosa cells
infertility
ageing
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2021-06-30
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women undergoing routine IVF treatment as part of their clinical treatment plan.

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of hormone production, protein and RNA expression
timeFrame: 0-14 days
Secondary outcomes:
measure: Correlation of cellular responses with age and cause of infertility.
timeFrame: 12 months
Other outcomes:
Locations:
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