Effects of Age and Infertility on Ovarian Granulosa Cell Function

NCT04945265 | Unknown

• 1 other identifier: 264510
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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).

Conditions

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

Keywords

ovary; granulosa cells; infertility; ageing

Outcome Measures

Primary Outcomes (1)

• 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

  0-14 days

Secondary Outcomes (1)

• Correlation of cellular responses with age and cause of infertility.

  12 months

Study Arms (11)

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.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Women undergoing routine IVF treatment as part of their clinical treatment plan.

You may qualify if:

• 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:
• unexplained infertility
• tubal disease
• egg freezing
• polycystic ovarian syndrome
• ovulatory disorders
• endometriosis
• male factor infertility
• any other cause of infertility such as fibroids.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King's College London: lead

MeSH Terms

Conditions

Infertility, Female; Infertility

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: June 30, 2021
• Study Start: July 1, 2021
• Primary Completion: July 1, 2024
• Study Completion: June 1, 2025
• Last Updated: July 7, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share