AgingNCT01389141
Age-related Changes in Ovarian Follicular Wave Dynamics
An observational study of Aging, run by University of Saskatchewan at 1 site in Canada.
Trial summary
The investigators hypothesize that age-related changes in the number and growth dynamics of ovarian follicles will be associated with changes in hormone levels and corresponding changes in musculoskeletal health. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Aging
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2010to Jun 2011
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Seventy healthy women, exhibiting all inclusion criteria and no exclusion criteria will be enrolled in this study. Women will be grouped into 1 of the following age categories: 1. . Mid-reproductive age (MRA): 18-35 years 2. . Late reproductive age-1 (LRA1): 36-44 years 3. . Late reproductive age -2 (LRA2): 45-55 years (this group will include women in the LRA, EMT and LMT groups, as previously characterized by STRAW)
Who may be able to join
- Informed consent obtained
- Age of 18-55
- 18<BMI<35
- Menstrual cycle history:
- MRA group: regular cycles
- LRA-1 group: history of regular cycles, with variable cycles allowed (no more than 3 months amenorrhea)
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- LRA-2 group: variable cycles allowed (no more than 3 months amenorrhea)
- Has not taken hormonal contraception within 2 months of initiating study procedures
- Agrees to use back-up contraception throughout the course of the study, if sexually active (condoms to be provided)
- 3.0 < Prolactin < 20.0 ug/L
- 0.30 < TSH < 5.50 mIU/L
- Normal complete blood count (CBC)
- Beta human Chorionic Gonadotropin < 5IU/L.
Who cannot join
- Smokers
- Documented ovarian failure
- History of or currently-diagnosed infertility of unexplained or female origin;
- Medical conditions known or suspected to interfere with reproductive function (including PCOS)
- Presence of only one ovary
- Ovaries inaccessible with transvaginal ultrasonography
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- The use of any medications known or suspected to interfere with reproductive function
- Ongoing pregnancy
- Lactation
- Participation in an investigational drug trial in the 30 days prior to the pre-study visit
- Planning to undergo surgery during the course of the study.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Reproductive Biology Research Unit, Department of Obstetrics, Gynecology and Reproductive Sciences, University of Saskatchewan
Saskatoon, Saskatchewan, S7N 0W8
About this study
Official title: Ovarian Follicular Wave Dynamics During The Menstrual Cycle: Relationship To Age, Reproductive Hormones And Musculoskeletal Health
The investigators hypothesize that age-related changes in the number and growth dynamics of ovarian follicles will be associated with changes in hormone levels and corresponding changes in musculoskeletal health.
Read the detailed description
The following hypotheses will be tested:
- Differences in ovarian follicular wave dynamics will be detected in women of different ages;
- The numbers and patterns of ovarian follicle waves in women are repeatable over multiple menstrual cycles;
- Differences in inhibin B, inhibin A, and AMH will be detected in women with 2 versus 3 or more follicular waves
- Differences in FSH, LH, progesterone, inhibin B, inhibin A, and AMH detected in MRA and LRA2 women, will change with the numbers of follicles and waves detected;
- 'Luteal out of phase events' (aka LOOP cycles) will be more prevalent in LRA2 versus MRA women, and will represent major anovulatory waves and/or ovulatory waves;
- When compared to MRA group, LRA2 women will have lower bone mineral mass and areal density at the lumbar spine; reduced trabecular density at the distal radius and thinner cortices with lower cortical density at the radial and tibial shaft. Other bone outcomes will be similar between the groups;
- When compared to MRA group, LRA2 women will have lower total body lean mass, greater fat mass and less dense muscle tissue at the forearm and lower limb and lower hand grip strength.
- Reduced bone mineral mass, areal density, trabecular density, cortical density and hand grip strength in LRA2 versus MRA women will be associated with reduced follicle number, a greater prevalence of LOOP cycles, higher serum FSH and lower inhibin concentrations
- Conditions
- Aging
- Keywords
- ovary, follicle, hormones, bone, muscle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| mid-reproductive age | Not described | |
| late reproductive age-1 | Not described | |
| late reproductive age-2 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Follicle diameter (mm)
Measured: 4 years
Secondary outcomes (9)
- Follicle number
Measured: 4 years
Serum FSH
Measured: 4 years
bone mineral density
Measured: 4 years
Serum LH
Measured: 4 years
Serum Estradiol
Measured: 4 years
Serum Progesterone
Measured: 4 years
Serum Inhibin A
Measured: 4 years
Serum Inhibin B
Measured: 4 years
Serum AMH
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2011 (estimated)
- Study startFeb 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AgingStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Foundation for Women's Health
- Responsible party
- Principal investigator, Angela Baerwald, University of Saskatchewan
- Investigators
- Angela R Baerwald, PhD, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389141
- Sponsor's protocol ID
- RBRU-ARB 003
- Status last verified
- Oct 2018
- First submitted
- 21 May 2010
- Last updated
- 1 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Baerwald 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 12748128Baerwald 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 12849812Antaya G, Vanden Brink H, Hee Lee C, Baerwald A. Repeatability of ovarian antral follicular wave dynamics in women. Front Endocrinol (Lausanne). 2026 Aug 17;17:1886924. doi: 10.3389/fendo.2026.1886924. eCollection 2026.
PubMed 42676382Bashir ST, Baerwald AR, Gastal MO, Pierson RA, Gastal EL. Follicle growth and endocrine dynamics in women with spontaneous luteinized unruptured follicles versus ovulation. Hum Reprod. 2018 Jun 1;33(6):1130-1140. doi: 10.1093/humrep/dey082.
PubMed 29659847Baerwald A, Vanden Brink H, Hunter C, Beuker D, Lim H, Lee CH, Chizen D. Age-related changes in luteal dynamics: preliminary associations with antral follicular dynamics and hormone production during the human menstrual cycle. Menopause. 2018 Apr;25(4):399-407. doi: 10.1097/GME.0000000000001021.
PubMed 29112593Vanden Brink H, Robertson DM, Lim H, Lee C, Chizen D, Harris G, Hale G, Burger H, Baerwald A. Associations Between Antral Ovarian Follicle Dynamics and Hormone Production Throughout the Menstrual Cycle as Women Age. J Clin Endocrinol Metab. 2015 Dec;100(12):4553-62. doi: 10.1210/jc.2015-2643. Epub 2015 Oct 14.
PubMed 26465392
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ovarian Follicular Wave Dynamics During The Menstrual Cycle: Relationship To Age, Reproductive Hormones And Musculoskeletal Health
- ClinicalTrials.gov ID
- NCT01389141
- Acronym / sponsor ID
- RBRU-ARB 003
- Conditions
- Aging
- Keywords
- ovary, follicle, hormones, bone, muscle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Canadian Foundation for Women's Health
- Study start
- Feb 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 7 Jul 2011 (estimated)
- 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 investigators hypothesize that age-related changes in the number and growth dynamics of ovarian follicles will be associated with changes in hormone levels and corresponding changes in musculoskeletal health.
Detailed description
The following hypotheses will be tested:
- Differences in ovarian follicular wave dynamics will be detected in women of different ages;
- The numbers and patterns of ovarian follicle waves in women are repeatable over multiple menstrual cycles;
- Differences in inhibin B, inhibin A, and AMH will be detected in women with 2 versus 3 or more follicular waves
- Differences in FSH, LH, progesterone, inhibin B, inhibin A, and AMH detected in MRA and LRA2 women, will change with the numbers of follicles and waves detected;
- 'Luteal out of phase events' (aka LOOP cycles) will be more prevalent in LRA2 versus MRA women, and will represent major anovulatory waves and/or ovulatory waves;
- When compared to MRA group, LRA2 women will have lower bone mineral mass and areal density at the lumbar spine; reduced trabecular density at the distal radius and thinner cortices with lower cortical density at the radial and tibial shaft. Other bone outcomes will be similar between the groups;
- When compared to MRA group, LRA2 women will have lower total body lean mass, greater fat mass and less dense muscle tissue at the forearm and lower limb and lower hand grip strength.
- Reduced bone mineral mass, areal density, trabecular density, cortical density and hand grip strength in LRA2 versus MRA women will be associated with reduced follicle number, a greater prevalence of LOOP cycles, higher serum FSH and lower inhibin concentrations
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| mid-reproductive age | – | – |
| late reproductive age-1 | – | – |
| late reproductive age-2 | – | – |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Seventy healthy women, exhibiting all inclusion criteria and no exclusion criteria will be enrolled in this study. Women will be grouped into 1 of the following age categories: 1. . Mid-reproductive age (MRA): 18-35 years 2. . Late reproductive age-1 (LRA1): 36-44 years 3. . Late reproductive age -2 (LRA2): 45-55 years (this group will include women in the LRA, EMT and LMT groups, as previously characterized by STRAW)
Key inclusion criteria (13 listed)
- Informed consent obtained
- Age of 18-55
- 18<BMI<35
- Menstrual cycle history:
- MRA group: regular cycles
Key exclusion criteria (11 listed)
- Smokers
- Documented ovarian failure
- History of or currently-diagnosed infertility of unexplained or female origin;
- Medical conditions known or suspected to interfere with reproductive function (including PCOS)
- Presence of only one ovary
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Follicle diameter (mm)
Time frame: 4 years
9 secondary outcomes
- Follicle number
Time frame: 4 years
Serum FSH
Time frame: 4 years
bone mineral density
Time frame: 4 years
Serum LH
Time frame: 4 years
Serum Estradiol
Time frame: 4 years
Serum Progesterone
Time frame: 4 years
Serum Inhibin A
Time frame: 4 years
Serum Inhibin B
Time frame: 4 years
Serum AMH
Time frame: 4 years
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 1 Nov 2018.
- 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.
- 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.
- Derived from this study: PubMed 42676382Antaya G, Vanden Brink H, Hee Lee C, Baerwald A. Repeatability of ovarian antral follicular wave dynamics in women. Front Endocrinol (Lausanne). 2026 Aug 17;17:1886924. doi: 10.3389/fendo.2026.1886924. eCollection 2026.
- Derived from this study: PubMed 29659847Bashir ST, Baerwald AR, Gastal MO, Pierson RA, Gastal EL. Follicle growth and endocrine dynamics in women with spontaneous luteinized unruptured follicles versus ovulation. Hum Reprod. 2018 Jun 1;33(6):1130-1140. doi: 10.1093/humrep/dey082.
- Derived from this study: PubMed 29112593Baerwald A, Vanden Brink H, Hunter C, Beuker D, Lim H, Lee CH, Chizen D. Age-related changes in luteal dynamics: preliminary associations with antral follicular dynamics and hormone production during the human menstrual cycle. Menopause. 2018 Apr;25(4):399-407. doi: 10.1097/GME.0000000000001021.
- Derived from this study: PubMed 26465392Vanden Brink H, Robertson DM, Lim H, Lee C, Chizen D, Harris G, Hale G, Burger H, Baerwald A. Associations Between Antral Ovarian Follicle Dynamics and Hormone Production Throughout the Menstrual Cycle as Women Age. J Clin Endocrinol Metab. 2015 Dec;100(12):4553-62. doi: 10.1210/jc.2015-2643. Epub 2015 Oct 14.
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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 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 Aging, 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 13 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 1 Nov 2018. 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?
Follicle diameter (mm) (time frame: 4 years). 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 NCT01389141, which also lists 6 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 1 Nov 2018.