Effects of Age and Infertility on Ovarian Granulosa Cell Function

Infertility Clinical Trial

Official title:

Mechanistic Insight Into Ovarian Granulosa Cell Function Based on Age and Cause of Infertility

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04945265
• Other study ID #: 264510
• Status: Not yet recruiting
• Start date: July 2021
• Est. completion date: June 2025

Study information

• Verified date: June 2021
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: June 2025
• Est. primary completion date: July 2024
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Infertility of Tubal Origin
• Infertility Unexplained
• Infertility, Female

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
King's College London

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Correlation of cellular responses with age and cause of infertility.	Assessed via statistical analysis	12 months