Effects of Age and Infertility on Ovarian Granulosa Cell Function

NCT ID: NCT04945265

Last Updated: 2021-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-31

Study Completion Date

2025-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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Infertility, Female Infertility Unexplained Infertility of Tubal Origin Infertility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Women aged <30

No interventions assigned to this group

Women aged 30-36

No interventions assigned to this group

Women aged 37-40

No interventions assigned to this group

Women aged >40

No interventions assigned to this group

Women undergoing egg freezing/male factor infertility/genetic testing

No interventions assigned to this group

unidentified cause of infertility

No interventions assigned to this group

PCOS

No interventions assigned to this group

endometriosis

No interventions assigned to this group

tubal disorders

No interventions assigned to this group

ovulatory disorders

No interventions assigned to this group

other causes of infertility e.g., fibroids.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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King's College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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264510

Identifier Type: -

Identifier Source: org_study_id

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