Effects of Age and Infertility on Ovarian Granulosa Cell Function

July 1, 2021 updated by: King's College London

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).

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
0-14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of cellular responses with age and cause of infertility.
Time Frame: 12 months
Assessed via statistical analysis
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2021

Primary Completion (Anticipated)

July 1, 2024

Study Completion (Anticipated)

June 1, 2025

Study Registration Dates

First Submitted

June 25, 2021

First Submitted That Met QC Criteria

June 25, 2021

First Posted (Actual)

June 30, 2021

Study Record Updates

Last Update Posted (Actual)

July 7, 2021

Last Update Submitted That Met QC Criteria

July 1, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 264510

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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