Age-related Changes in Ovarian Follicular Wave Dynamics

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 evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01389141
Recruitment Status : Completed
First Posted : July 7, 2011
Last Update Posted : August 15, 2011
Canadian Foundation for Women's Health
Information provided by:
University of Saskatchewan

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.

Condition or disease

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 Type : Observational
Actual Enrollment : 70 participants
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
Study Start Date : February 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

mid-reproductive age
late reproductive age-1
late reproductive age-2

Primary Outcome Measures :
  1. Follicle diameter (mm) [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. - Follicle number [ Time Frame: 4 years ]
  2. Serum FSH [ Time Frame: 4 years ]
  3. bone mineral density [ Time Frame: 4 years ]
  4. Serum LH [ Time Frame: 4 years ]
  5. Serum Estradiol [ Time Frame: 4 years ]
  6. Serum Progesterone [ Time Frame: 4 years ]
  7. Serum Inhibin A [ Time Frame: 4 years ]
  8. Serum Inhibin B [ Time Frame: 4 years ]
  9. Serum AMH [ Time Frame: 4 years ]

Biospecimen Retention:   Samples Without DNA
Serum samples are isolated and frozen for retrospective analyses.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes 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)

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01389141

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
Principal Investigator: Angela R Baerwald, PhD University of Saskatchewan