Egg Quality Assessment

NCT06609421 | Suspended

• 1 other identifier: 340652
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about egg physiology in humans. The main question it aims to answer is if there is an association between egg physiology and egg quality. Discarded, unfertilised eggs and follicular fluid collected during routine egg retrieval from participants undergoing in vitro fertilisation (IVF) as part of their regular medical care along with information from participants' electronic medical records will be collected and analysed.

Conditions

Infertility (IVF Patients); Ovarian Aging; IVF

Outcome Measures

Primary Outcomes (1)

• Mitochondrial physiology in the oocytes

  Baseline time of observation which lasts between 1 and 5 hours

Secondary Outcomes (1)

• Comparison of oocyte mitochondrial physiology results to clinical outcomes to assess correlation (or lack thereof)

  As the data becomes available over the course of the participants' medical treatment. E.g. From enrolment until birth of an infant

Study Arms (2)

Control Group

Women undergoing in-vitro fertilisation (IVF) with male factor diagnoses.

Other: Informative Appointment

Case Group

Women undergoing IVF with a diagnosis other than male factor.

Other: Informative Appointment

Interventions

Informative Appointment OTHER

The only intervention involving the participants is non-clinical, which is an extra 30-minute informative telephone appointment added to the standard care consultation schedule of interested IVF patients where they will be presented with a digital consent PDF form to sign by a study nurse or clinically trained research personnel. Participants will be in the study for 24-30 months. During this time their discarded, unfertilised oocytes and follicular fluid collected during routine oocyte retrieval along with information from their electronic medical records will be collected and analysed.

Case Group; Control Group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People with uteri experiencing infertility issues requiring assisted reproduction via in vitro fertilisation (IVF)/intracytoplasmic sperm injection (ICSI) or undergoing elective egg freezing.

You may qualify if:

• Undergoing in vitro fertilisation treatment or egg freezing

You may not qualify if:

• No discarded, unfertilised eggs for collection

Sponsors & Collaborators

• Ovom Care GmbH: lead

Study Sites (1)

Avenues Clinic

London, NW1 1BU, United Kingdom

Location

Related Publications (1)

• Brayboy LM, Oulhen N, Witmyer J, Robins J, Carson S, Wessel GM. Multidrug-resistant transport activity protects oocytes from chemotherapeutic agents and changes during oocyte maturation. Fertil Steril. 2013 Nov;100(5):1428-35. doi: 10.1016/j.fertnstert.2013.07.002. Epub 2013 Aug 13.

  PMID: 23953328 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Discarded, unfertilised oocytes and follicular fluid collected during routine oocyte retrieval

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2024
• First Posted: September 24, 2024
• Study Start: October 9, 2024
• Primary Completion: November 8, 2024
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)