Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000819426
Ethics application status
Approved
Date submitted
14/07/2025
Date registered
31/07/2025
Date last updated
31/07/2025
Date data sharing statement initially provided
31/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Reproductive Health and Your Menstruation: an observational study looking at endometrial ageing in menstrual fluid.
Scientific title
An observational study exploring circRNAs and key hallmarks of endometrial ageing in menstrual fluid from women of different reproductive ages and/or with polycystic ovary syndrome (PCOS).
Secondary ID [1] 314859 0
None
Universal Trial Number (UTN)
Trial acronym
RHYM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Menstrual Health 338136 0
Condition category
Condition code
Reproductive Health and Childbirth 334420 334420 0 0
Menstruation and menopause

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This pilot study will explore endometrial health using menstrual fluid and how it may differ between women of different age and reproductive health.
A minimum of 30 women will be recruited for this study who are of different ages, have healthy menstrual cycles or have a reproductive condition, Polycystic Ovary Syndrome (PCOS). Group 1 are 18-25 within reproductive age with typical menstrual cycles. Group 2 are 35-43 within reproductive age with typical menstrual cycles. Group 3 will be with varied reproductive age and have a self-reported diagnosis of PCOS. Menstrual fluid samples will be self collected once only on day 2 of menses for 4-6 hours. Peripheral blood will be taken once only on the day before the next predicted period begins. Participation is for one menstrual cycle only. Data generated will be used for a power analysis for a future study.
Intervention code [1] 331462 0
Not applicable
Comparator / control treatment
The younger age group of 18-25 are the control group. They will have typical menstrual cycles, with no known reproductive disorders.
Control group
Active

Outcomes
Primary outcome [1] 342119 0
Successful identification of circRNA in endometrial cells isolated from menstrual fluid.
Timepoint [1] 342119 0
Day 2 of menstruation for one menstrual cycle only
Primary outcome [2] 342352 0
Successful quantification of circRNA in endometrial cells isolated from menstrual fluid.
Timepoint [2] 342352 0
Day 2 of menstruation for one menstrual cycle only
Secondary outcome [1] 449604 0
Measures of DNA damage in endometrial cells from menstrual fluid
Timepoint [1] 449604 0
Day 2 of menstruation for one menstrual cycle only
Secondary outcome [2] 450461 0
Measures of lipid peroxidation in endometrial cells from menstrual fluid
Timepoint [2] 450461 0
Day 2 of menstruation for one menstrual cycle only

Eligibility
Key inclusion criteria
Group 1:
Individuals who are assigned female at birth
18-25 years who have typical menstrual cycles
Willing to complete questionnaires and use a menstrual cup to collect their own menstrual fluid

Group 2:
Individuals who are assigned female at birth
35-43 years who have typical menstrual cycles
Willing to complete questionnaires and use a menstrual cup to collect their own menstrual fluid

Group 3:
Individuals who are assigned female at birth
18-43 years who have been diagnosed with PCOS
Willing to complete questionnaires and use a menstrual cup to collect their own menstrual fluid
Minimum age
18 Years
Maximum age
43 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they:
(i) Are on any hormonal contraception/therapy
(ii) Have severe chronic pelvic pain
(iii) Have other reproductive disorders (excluding PCOS)
(iv) Have a history of infertility (excluding PCOS group)
(v) Have a sexually transmitted infection
(vi) Have been taught by one of our researchers in the past 12 months.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
A two-way ANOVA with BMI and age of menarche as covariates, followed by Tukey's post hoc for multiple comparisons. This is a pilot study to generate data for a power analysis for a future appropriately powered study.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/08/2025
Actual
Date of last participant enrolment
Anticipated
29/08/2025
Actual
Date of last data collection
Anticipated
30/09/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 319417 0
Government body
Name [1] 319417 0
NHMRC
Country [1] 319417 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Country
Australia
Secondary sponsor category [1] 321903 0
None
Name [1] 321903 0
Address [1] 321903 0
Country [1] 321903 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317988 0
Flinders University Human Research Ethics Committee
Ethics committee address [1] 317988 0
Ethics committee country [1] 317988 0
Australia
Date submitted for ethics approval [1] 317988 0
31/03/2025
Approval date [1] 317988 0
27/05/2025
Ethics approval number [1] 317988 0
8459

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 142794 0
Prof Claire Roberts
Address 142794 0
Level 4, HMRB Building, Flinders University, Bedford Park, SA 5042
Country 142794 0
Australia
Phone 142794 0
+61406381575
Fax 142794 0
Email 142794 0
[email protected]
Contact person for public queries
Name 142795 0
Claudia Belmonte
Address 142795 0
Level 4, HMRB Building, Flinders University, Bedford Park, SA 5042
Country 142795 0
Australia
Phone 142795 0
+61424757646
Fax 142795 0
Email 142795 0
[email protected]
Contact person for scientific queries
Name 142796 0
Claire Roberts
Address 142796 0
Level 4, HMRB Building, Flinders University, Bedford Park, SA 5042
Country 142796 0
Australia
Phone 142796 0
+61406381575
Fax 142796 0
Email 142796 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    20250630 RHYM Approval Letter.pdf
Ethical approval    20250527 RHYM Approval Letter.pdf


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.