Reproductive IssuesNCT05531357
Physiologic Mechanisms Underlying Ovarian Follicular Waves During the Menstrual Cycle
An observational study of Reproductive Issues, run by University of Saskatchewan at 1 site in Canada.
Trial summary
The research aims to characterize changes in ovarian and pituitary hormones associated with the development of ovarian follicular waves during the human menstrual cycle. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Reproductive Issues
- What is being tested?
- Transvaginal ultrasound scans
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 17 Sep 2022to 26 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Volunteers who respond to advertisements placed in the community, local offices and the University of Saskatchewan's website
Who may be able to join
- Healthy biological females
- Regular menstrual cycles (21-35 days)
Who cannot join
- BMI <18 or >30
- Pregnancy
- Breastfeeding mothers
- Current infertility
- History of hysterectomy or oophorectomy
- Reproductive health issues that can interfere with study outcomes
Show all 11Show fewer
- Smoking
- Metabolic syndrome (blood pressure, fasting glucose, fasting insulin and serum lipids measured to assess eligibility)
- Not on any hormonal medication that affects reproduction (including hormonal contraception)
- Hyperprolactinemia
- Abnormal thyroid stimulating hormone assay
Trial locations and contacts
1 site in 1 country.
About this study
The research aims to characterize changes in ovarian and pituitary hormones associated with the development of ovarian follicular waves during the human menstrual cycle.
Read the detailed description
Our laboratory's previous research has demonstrated that multiple waves of ovarian follicles develop throughout the menstrual cycle. Approximately 2/3 of women develop 2 follicle waves throughout their cycle while the remainder exhibit 3 waves of follicle growth (1,2). This study is to follow up on those findings to determine how pituitary and ovarian hormones regulate the development of follicle waves in women, with a combination of ultrasound scans and blood and urine sampling to characterize how follicles grow during the menstrual cycle in 50 women of reproductive age. Changes in follicle growth across the cycle will be compared with changes in hormone production.
The new findings will be essential for improving understanding of female reproduction, with clinical applications in contraception, fertility and menopausal care for women across their reproductive lifespan.
- Conditions
- Reproductive Issues
- Being tested
- Transvaginal ultrasound scans
- Keywords
- ovarian follicles, ovulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal ultrasound scansDiagnostic test
Also called Finger-prick blood sampling for dried blood spots, Urine sampling, Venipunctures
Transvaginal ultrasound scans to map ovarian follicle growth and ovulation, finger-prick blood sampling for dried blood spot (DBS) hormonal assays and urine sampling for hormone metabolites, every consecutive day for an interovulatory interval.
Weekly venipuncture samples will be taken for standard ELISA hormonal assays. The hormones of interest are FSH, LH, estradiol, progesterone, AMH, inhibins A and B, GDF-9 and BMP-15.
What is being measured
The primary outcome is the main question the study is designed to answer.
Antral follicle diameter
Daily diameters of individual follicles ≥ 2mm from ultrasound examination
Measured: One menstrual cycle (21-35 days) per volunteer
Antral follicle count
Daily count of the number of follicles >2 mm from ultrasound examination
Measured: One menstrual cycle (21-35 days) per volunteer
Follicle stimulating hormone (FSH) serum level
Daily measurements of FSH in IU/L
Measured: One menstrual cycle (21-35 days) per volunteer
Luteinizing hormone (LH) serum level
Daily measurements of LH in IU/L
Measured: One menstrual cycle (21-35 days) per volunteer
Estradiol serum level
Daily measurements of estradiol in pg/mL
Measured: One menstrual cycle (21-35 days) per volunteer
Progesterone serum level
Daily measurements of progesterone in ng/mL
Measured: One menstrual cycle (21-35 days) per volunteer
Anti-mullerian hormone (AMH) serum level
Daily measurements of AMH in ng/mL
Measured: One menstrual cycle (21-35 days) per volunteer
Inhibin A serum level
Daily measurements of inhibin A in pg/mL
Measured: One menstrual cycle (21-35 days) per volunteer
Inhibin B serum level
Daily measurements of inhibin B in pg/mL
Measured: One menstrual cycle (21-35 days) per volunteer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start17 Sep 2022
- Primary completion26 Mar 2024
- Study completion26 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Reproductive IssuesStudies of the same condition, open and under way.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Ansh Labs
- Responsible party
- Principal investigator, Angela Baerwald, University of Saskatchewan
- Investigators
- Angela R Baerwald, PhD,MD,CCFP, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05531357
- Sponsor's protocol ID
- Bio 2080
- Status last verified
- May 2024
- First submitted
- 29 Aug 2022
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baerwald AR, Adams GP, Pierson RA. A new model for ovarian follicular development during the human menstrual cycle. Fertil Steril. 2003 Jul;80(1):116-22. doi: 10.1016/s0015-0282(03)00544-2.
PubMed 12849812Baerwald AR, Adams GP, Pierson RA. Characterization of ovarian follicular wave dynamics in women. Biol Reprod. 2003 Sep;69(3):1023-31. doi: 10.1095/biolreprod.103.017772. Epub 2003 May 14.
PubMed 12748128
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiologic Mechanisms Underlying Ovarian Follicular Waves During the Menstrual Cycle
- ClinicalTrials.gov ID
- NCT05531357
- Acronym / sponsor ID
- Bio 2080
- Conditions
- Reproductive Issues
- Keywords
- ovarian follicles, ovulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Ansh Labs
- Study start
- 17 Sep 2022 (actual)
- Primary completion
- 26 Mar 2024 (actual)
- Study completion
- 26 Mar 2024 (actual)
- First posted
- 7 Sep 2022 (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.
The research aims to characterize changes in ovarian and pituitary hormones associated with the development of ovarian follicular waves during the human menstrual cycle.
Detailed description
Our laboratory's previous research has demonstrated that multiple waves of ovarian follicles develop throughout the menstrual cycle. Approximately 2/3 of women develop 2 follicle waves throughout their cycle while the remainder exhibit 3 waves of follicle growth (1,2). This study is to follow up on those findings to determine how pituitary and ovarian hormones regulate the development of follicle waves in women, with a combination of ultrasound scans and blood and urine sampling to characterize how follicles grow during the menstrual cycle in 50 women of reproductive age. Changes in follicle growth across the cycle will be compared with changes in hormone production.
The new findings will be essential for improving understanding of female reproduction, with clinical applications in contraception, fertility and menopausal care for women across their reproductive lifespan.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Volunteers who respond to advertisements placed in the community, local offices and the University of Saskatchewan's website
Key inclusion criteria (2 listed)
- Healthy biological females
- Regular menstrual cycles (21-35 days)
Key exclusion criteria (11 listed)
- BMI <18 or >30
- Pregnancy
- Breastfeeding mothers
- Current infertility
- History of hysterectomy or oophorectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transvaginal ultrasound scansAlso: Finger-prick blood sampling for dried blood spots, Urine sampling, VenipuncturesTransvaginal ultrasound scans to map ovarian follicle growth and ovulation, finger-prick blood sampling for dried blood spot (DBS) hormonal assays and urine sampling for hormone metabolites, every consecutive day for an interovulatory interval. Weekly venipuncture samples will be taken for standard ELISA hormonal assays. The hormones of interest are FSH, LH, estradiol, progesterone, AMH, inhibins A and B, GDF-9 and BMP-15. | Diagnostic test | – |
Primary outcome
Antral follicle diameter
Time frame: One menstrual cycle (21-35 days) per volunteer
Daily diameters of individual follicles ≥ 2mm from ultrasound examination
Antral follicle count
Time frame: One menstrual cycle (21-35 days) per volunteer
Daily count of the number of follicles >2 mm from ultrasound examination
Follicle stimulating hormone (FSH) serum level
Time frame: One menstrual cycle (21-35 days) per volunteer
Daily measurements of FSH in IU/L
Luteinizing hormone (LH) serum level
Time frame: One menstrual cycle (21-35 days) per volunteer
Daily measurements of LH in IU/L
Estradiol serum level
Time frame: One menstrual cycle (21-35 days) per volunteer
Daily measurements of estradiol in pg/mL
Progesterone serum level
Time frame: One menstrual cycle (21-35 days) per volunteer
Daily measurements of progesterone in ng/mL
Anti-mullerian hormone (AMH) serum level
Time frame: One menstrual cycle (21-35 days) per volunteer
Daily measurements of AMH in ng/mL
Inhibin A serum level
Time frame: One menstrual cycle (21-35 days) per volunteer
Daily measurements of inhibin A in pg/mL
Inhibin B serum level
Time frame: One menstrual cycle (21-35 days) per volunteer
Daily measurements of inhibin B in pg/mL
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Background: PubMed 12849812Baerwald AR, Adams GP, Pierson RA. A new model for ovarian follicular development during the human menstrual cycle. Fertil Steril. 2003 Jul;80(1):116-22. doi: 10.1016/s0015-0282(03)00544-2.
- Background: PubMed 12748128Baerwald AR, Adams GP, Pierson RA. Characterization of ovarian follicular wave dynamics in women. Biol Reprod. 2003 Sep;69(3):1023-31. doi: 10.1095/biolreprod.103.017772. Epub 2003 May 14.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Angela R Baerwald, PhD,MD,CCFP principal investigator
University of Saskatchewan
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 Reproductive Issues, run by University of Saskatchewan at 1 site in Canada.
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 2 inclusion and 11 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: finished, as of the sponsor's last update on 17 May 2024. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antral follicle diameter (time frame: One menstrual cycle (21-35 days) per volunteer). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05531357, which also lists 2 linked publications.
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 17 May 2024.