Oocyte MaturationNCT04382872
Follicular Fluid Exosome miRNA During Oocyte Maturation
An observational study of Oocyte Maturation, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Oocyte Maturation
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 30 Apr 2021to 30 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: women undergoing oocyte retrieval treatment
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Chinese University of Hong Kong
Hong Kong
Pui Wah Chung, 85235051537, jacquelinechung@cuhk.edu.hk
Wing Ching Cheung, PhD, 85235051764, cosycheung@cuhk.edu.hk
About this study
Official title: Investigation of Follicular Fluid Exosome miRNA in Young and Aged Women During Oocyte Maturation
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.
Read the detailed description
In recent decades, demographic and socioeconomic factors have resulted in marked changes in human society that include postponement of child bearing and a subsequent rise in mean age at first childbirth. Aged women have more reproductive problems (including menstrual irregulation and decreased ovarian reserve as reflected by reduced anti-mullerian hormone (AMH)) and their oocytes are often of lower quality when compared to younger women.
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, defined as the ability of the oocyte to complete follicular development, and to undergo fertilization and embryogenesis is impaired in aged women. Age-related decline in female fertility is mainly driven by ovarian aging, or diminished ovarian function associated with age. 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. Transcription studies have suggested indirectly that some age-related changes in oocyte gene expression and cell to cell communication may involve epigenetic machinery.
Ovarian follicle may be one of the best models in human for exosome study considering the role of the granulosa cells and follicular fluid for oocyte maturation. In the ovarian follicle, follicular fluid (FF) exosome may play an important mediated communication role between the oocyte and surrounding granulosa cells.
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.
- Conditions
- Oocyte Maturation
- Keywords
- oocyte maturation, in vitro maturation
What is being measured
The primary outcome is the main question the study is designed to answer.
RNA-sequencing
- To identify for the first time FF exosome miRNAs in mature and immature follicles in young and aged women by RNA-sequencing (RNA-seq).
Measured: through study completion, an average of 2 years
quantitative real-time polymerase chain reaction
- 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).
Measured: through study completion, an average of 2 years
Secondary outcomes (1)
fertilization and pregnancy rate
- To observe the effect of the identified specific FF exosome miRNAs on oocyte maturation (by IVM) and assess the association of the miRNAs on fertilization and pregnancy rate.
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start30 Apr 2021
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oocyte MaturationStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chung Pui Wah Jacqueline, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04382872
- Sponsor's protocol ID
- 2019.137
- Status last verified
- Aug 2025
- First submitted
- 23 Apr 2020
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Follicular Fluid Exosome miRNA in Young and Aged Women During Oocyte Maturation
- ClinicalTrials.gov ID
- NCT04382872
- Acronym / sponsor ID
- 2019.137
- Conditions
- Oocyte Maturation
- Keywords
- oocyte maturation, in vitro maturation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 11 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In recent decades, demographic and socioeconomic factors have resulted in marked changes in human society that include postponement of child bearing and a subsequent rise in mean age at first childbirth. Aged women have more reproductive problems (including menstrual irregulation and decreased ovarian reserve as reflected by reduced anti-mullerian hormone (AMH)) and their oocytes are often of lower quality when compared to younger women.
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, defined as the ability of the oocyte to complete follicular development, and to undergo fertilization and embryogenesis is impaired in aged women. Age-related decline in female fertility is mainly driven by ovarian aging, or diminished ovarian function associated with age. 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. Transcription studies have suggested indirectly that some age-related changes in oocyte gene expression and cell to cell communication may involve epigenetic machinery.
Ovarian follicle may be one of the best models in human for exosome study considering the role of the granulosa cells and follicular fluid for oocyte maturation. In the ovarian follicle, follicular fluid (FF) exosome may play an important mediated communication role between the oocyte and surrounding granulosa cells.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- women undergoing oocyte retrieval treatment
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
RNA-sequencing
Time frame: through study completion, an average of 2 years
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).
quantitative real-time polymerase chain reaction
Time frame: through study completion, an average of 2 years
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).
1 secondary outcome
fertilization and pregnancy rate
Time frame: through study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oocyte Maturation, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RNA-sequencing (time frame: through study completion, an average of 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.