Clinical trial NCT04382872: Follicular Fluid Exosome miRNA During Oocyte Maturation
Official title: Investigation of Follicular Fluid Exosome miRNA in Young and Aged Women During Oocyte Maturation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Oocyte Maturation
Keywords: oocyte maturation
in vitro maturation
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-05-11
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: women undergoing oocyte retrieval treatment

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: RNA-sequencing
timeFrame: through study completion, an average of 2 years
measure: quantitative real-time polymerase chain reaction
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: fertilization and pregnancy rate
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
References: