Age-related Changes in Ovarian Follicular Wave Dynamics

This study has been completed.
Sponsor:
Collaborator:
Canadian Foundation for Women's Health
Information provided by:
University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT01389141
First received: May 21, 2010
Last updated: August 11, 2011
Last verified: August 2011
  Purpose

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.


Condition
Aging

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Ovarian Follicular Wave Dynamics During The Menstrual Cycle: Relationship To Age, Reproductive Hormones And Musculoskeletal Health

Further study details as provided by University of Saskatchewan:

Primary Outcome Measures:
  • Follicle diameter (mm) [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • - Follicle number [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Serum FSH [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • bone mineral density [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Serum LH [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Serum Estradiol [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Serum Progesterone [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Serum Inhibin A [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Serum Inhibin B [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Serum AMH [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Serum samples are isolated and frozen for retrospective analyses.


Enrollment: 70
Study Start Date: February 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
mid-reproductive age
late reproductive age-1
late reproductive age-2

Detailed Description:

The following hypotheses will be tested:

  1. Differences in ovarian follicular wave dynamics will be detected in women of different ages;
  2. The numbers and patterns of ovarian follicle waves in women are repeatable over multiple menstrual cycles;
  3. Differences in inhibin B, inhibin A, and AMH will be detected in women with 2 versus 3 or more follicular waves
  4. 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;
  5. '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;
  6. 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;
  7. 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.
  8. 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
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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)
Criteria

Inclusion Criteria:

  • 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)
  • 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.

Exclusion Criteria:

  • 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
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01389141

Locations
Canada, Saskatchewan
Reproductive Biology Research Unit, Department of Obstetrics, Gynecology and Reproductive Sciences, University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
University of Saskatchewan
Canadian Foundation for Women's Health
Investigators
Principal Investigator: Angela R Baerwald, PhD University of Saskatchewan
  More Information

Publications:
Responsible Party: Angela Baerwald/ Principal Investigator, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT01389141     History of Changes
Other Study ID Numbers: RBRU-ARB 003
Study First Received: May 21, 2010
Last Updated: August 11, 2011
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

Keywords provided by University of Saskatchewan:
ovary
follicle
hormones
bone
muscle

ClinicalTrials.gov processed this record on October 22, 2014