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Effects of Age and Infertility on Ovarian Granulosa Cell Function

Sponsor
King's College London (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04945265
Collaborator
(none)
500
Enrollment
47
Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Mechanistic Insight Into Ovarian Granulosa Cell Function Based on Age and Cause of Infertility
    Anticipated Study Start Date :
    Jul 1, 2021
    Anticipated Primary Completion Date :
    Jul 1, 2024
    Anticipated Study Completion Date :
    Jun 1, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Assessment of hormone production, protein and RNA expression [0-14 days]

      Assessed via cellular signalling responses to endocrine stimulation, production of steroid hormones, protein analysis and RNA analysis

    Secondary Outcome Measures

    1. Correlation of cellular responses with age and cause of infertility. [12 months]

      Assessed via statistical analysis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • King's College London

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    King's College London
    ClinicalTrials.gov Identifier:
    NCT04945265
    Other Study ID Numbers:
    • 264510
    First Posted:
    Jun 30, 2021
    Last Update Posted:
    Jul 7, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by King's College London
    ovary
    granulosa cells
    infertility
    ageing
    Additional relevant MeSH terms:
    Infertility
    Infertility, Female

    Study Results

    No Results Posted as of Jul 7, 2021