- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04382872
Follicular Fluid Exosome miRNA During Oocyte Maturation
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Hong Kong, Hong Kong
- Recruiting
- The Chinese University of Hong Kong
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Contact:
- Pui Wah Chung
- Phone Number: 85235051537
- Email: jacquelinechung@cuhk.edu.hk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
RNA-sequencing
Time Frame: through study completion, an average of 2 years
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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).
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through study completion, an average of 2 years
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quantitative real-time polymerase chain reaction
Time Frame: through study completion, an average of 2 years
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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).
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through study completion, an average of 2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
fertilization and pregnancy rate
Time Frame: through study completion, an average of 2 years
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3) 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.
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through study completion, an average of 2 years
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2019.137
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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