NCT01389141

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 7, 2011

Completed
Last Updated

November 1, 2018

Status Verified

October 1, 2018

Enrollment Period

1.3 years

First QC Date

May 21, 2010

Last Update Submit

October 30, 2018

Conditions

Aging

Keywords

ovaryfolliclehormonesbonemuscle

Outcome Measures

Primary Outcomes (1)

  • Follicle diameter (mm)

    4 years

Secondary Outcomes (9)

  • - Follicle number

    4 years

  • Serum FSH

    4 years

  • bone mineral density

    4 years

  • Serum LH

    4 years

  • Serum Estradiol

    4 years

  • +4 more secondary outcomes

Study Arms (3)

mid-reproductive age

late reproductive age-1

late reproductive age-2

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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)

You may qualify if:

  • Informed consent obtained
  • Age of 18-55
  • \<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)
  • \< Prolactin \< 20.0 ug/L
  • \< TSH \< 5.50 mIU/L
  • Normal complete blood count (CBC)
  • Beta human Chorionic Gonadotropin \< 5IU/L.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reproductive Biology Research Unit, Department of Obstetrics, Gynecology and Reproductive Sciences, University of Saskatchewan

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Related Publications (5)

  • 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.

    PMID: 12748128BACKGROUND

  • 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.

    PMID: 12849812BACKGROUND

  • Bashir 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.

    PMID: 29659847DERIVED

  • Baerwald 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.

    PMID: 29112593DERIVED

  • Vanden 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.

    PMID: 26465392DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples are isolated and frozen for retrospective analyses.

Study Officials

  • Angela R Baerwald, PhD

    University of Saskatchewan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

May 21, 2010

First Posted

July 7, 2011

Study Start

February 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

November 1, 2018

Record last verified: 2018-10

Locations

CA(1)