NCT04382872

Brief Summary

Folliculogenesis involves the recruitment of primordial follicles into a group of growing follicles in which eventually one follicle is selected, matured and ovulated. Complex endocrine and intra-ovarian paracrine interactions occur to create a changing intra-follicular hormonal milieu suitable for oocyte development. However, this oocyte developmental competence and to undergo fertilization and embryogenesis is impaired in aged women. Diminished ovarian function is generally attributed to decreased quantity and quality of oocytes and their surrounding granulosa cells during ovarian aging, although the underlying mechanisms remain unclear. The aim of the study is to investigate the miRNA in (follicular fluid) FF exosome in young and aged women and their relationship to egg maturation.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 11, 2020

Completed
12 months until next milestone

Study Start

First participant enrolled

April 30, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

August 13, 2025

Status Verified

August 1, 2025

Enrollment Period

5 years

First QC Date

April 23, 2020

Last Update Submit

August 12, 2025

Conditions

Keywords

oocyte maturationin vitro maturation

Outcome Measures

Primary Outcomes (2)

  • RNA-sequencing

    1\) To identify for the first time FF exosome miRNAs in mature and immature follicles in young and aged women by RNA-sequencing (RNA-seq).

    through study completion, an average of 2 years

  • quantitative real-time polymerase chain reaction

    2\) To verify the identified FF exosome miRNAs in mature and immature follicles in young and aged women and investigate their expression in the corresponding granulosa cells by quantitative real-time polymerase chain reaction (qRT-PCR).

    through study completion, an average of 2 years

Secondary Outcomes (1)

  • fertilization and pregnancy rate

    through study completion, an average of 2 years

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsthis study required the subject to provide follicular fluid and immature oocyte, and therefore the subjects must be female
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

women undergoing oocyte retrieval treatment

You may qualify if:

  • Women aged 20 to 45;
  • BMI \> 19 \& \< 35;
  • Women who is planning to perform invitro fertilization (IVF) together with intracytoplasmic sperm injection (ICSI) for their fertility problems

You may not qualify if:

  • Positive pregnancy test before taking study medications;
  • Women with BMI\>35 kg/m2;
  • Women with known chromosomal translocation, recurrent abortions or those carrying Fragile X;
  • Women with endometriosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 23, 2020

First Posted

May 11, 2020

Study Start

April 30, 2021

Primary Completion

April 30, 2026

Study Completion

April 30, 2026

Last Updated

August 13, 2025

Record last verified: 2025-08

Locations