Follicular Fluid Exosome miRNA During Oocyte Maturation

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04382872
Collaborator
(none)
60
1
39
1.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Investigation of Follicular Fluid Exosome miRNA in Young and Aged Women During Oocyte Maturation
    Anticipated Study Start Date :
    Jan 30, 2021
    Anticipated Primary Completion Date :
    Apr 30, 2023
    Anticipated Study Completion Date :
    Apr 30, 2024

    Outcome Measures

    Primary Outcome Measures

    1. RNA-sequencing [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).

    2. quantitative real-time polymerase chain reaction [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).

    Secondary Outcome Measures

    1. fertilization and pregnancy rate [through study completion, an average of 2 years]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. Women aged 20 to 45;

    2. BMI > 19 & < 35;

    3. Women who is planning to perform invitro fertilization (IVF) together with intracytoplasmic sperm injection (ICSI) for their fertility problems

    Exclusion Criteria:
    1. Positive pregnancy test before taking study medications;

    2. Women with BMI>35 kg/m2;

    3. Women with known chromosomal translocation, recurrent abortions or those carrying Fragile X;

    4. Women with endometriosis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Chinese University of Hong Kong Hong Kong Hong Kong

    Sponsors and Collaborators

    • Chinese University of Hong Kong

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chung Pui Wah Jacqueline, Assistant professor, Chinese University of Hong Kong
    ClinicalTrials.gov Identifier:
    NCT04382872
    Other Study ID Numbers:
    • 2019.137
    First Posted:
    May 11, 2020
    Last Update Posted:
    Jul 28, 2020
    Last Verified:
    Jul 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Chung Pui Wah Jacqueline, Assistant professor, Chinese University of Hong Kong

    Study Results

    No Results Posted as of Jul 28, 2020