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Clinical Trials/NCT01389141
NCT01389141CompletedNot Applicable

Ovarian Follicular Wave Dynamics During The Menstrual Cycle: Relationship To Age, Reproductive Hormones And Musculoskeletal Health

University of Saskatchewan1 site in 1 country70 target enrollmentStarted: February 2010Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
70
Locations
1
Primary Endpoint
Follicle diameter (mm)

Study Overview

Brief 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.

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

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

  • 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.

Outcomes

Primary Outcomes

Follicle diameter (mm)

Time Frame: 4 years

Secondary Outcomes

  • bone mineral density(4 years)
  • - Follicle number(4 years)
  • Serum Inhibin B(4 years)
  • Serum FSH(4 years)
  • Serum LH(4 years)
  • Serum Progesterone(4 years)
  • Serum Inhibin A(4 years)
  • Serum AMH(4 years)
  • Serum Estradiol(4 years)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Angela Baerwald

M.D.

University of Saskatchewan

Study Sites (1)

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