Effects of Age and Infertility on Ovarian Granulosa Cell Function

King's College London

Status: Not yet enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT04945265

264510

Details and patient eligibility

About

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).

Enrollment: 500 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

500 participants in 11 patient groups

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.