Age-related Changes in Ovarian Follicular Wave Dynamics

NCT ID: NCT01389141

Last Updated: 2018-11-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2011-06-30

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

Conditions

Aging

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

mid-reproductive age

No interventions assigned to this group

late reproductive age-1

No interventions assigned to this group

late reproductive age-2

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Foundation for Women's Health

OTHER

Sponsor Role: collaborator

University of Saskatchewan

OTHER

Sponsor Role: lead

Responsible Party

Angela Baerwald

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Angela R Baerwald, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Saskatchewan

Locations

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

Saskatoon, Saskatchewan, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 12748128 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12849812 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29659847 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29112593 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26465392 (View on PubMed)

Other Identifiers

RBRU-ARB 003

Identifier Type: -

Identifier Source: org_study_id