Physiologic Mechanisms Underlying Ovarian Follicular Waves During the Menstrual Cycle

The research aims to characterize changes in ovarian and pituitary hormones associated with the development of ovarian follicular waves during the human menstrual cycle.

Study Overview

• Status: Completed
• Conditions: Reproductive Issues
• Intervention / Treatment: Diagnostic test: Transvaginal ultrasound scans

Detailed Description

Our laboratory's previous research has demonstrated that multiple waves of ovarian follicles develop throughout the menstrual cycle. Approximately 2/3 of women develop 2 follicle waves throughout their cycle while the remainder exhibit 3 waves of follicle growth (1,2). This study is to follow up on those findings to determine how pituitary and ovarian hormones regulate the development of follicle waves in women, with a combination of ultrasound scans and blood and urine sampling to characterize how follicles grow during the menstrual cycle in 50 women of reproductive age. Changes in follicle growth across the cycle will be compared with changes in hormone production.

The new findings will be essential for improving understanding of female reproduction, with clinical applications in contraception, fertility and menopausal care for women across their reproductive lifespan.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Canada
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 5A2
      • University of Saskatchewan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Volunteers who respond to advertisements placed in the community, local offices and the University of Saskatchewan's website

Description

Inclusion Criteria:

• Healthy biological females
• Regular menstrual cycles (21-35 days)

Exclusion Criteria:

• BMI <18 or >30
• Pregnancy
• Breastfeeding mothers
• Current infertility
• History of hysterectomy or oophorectomy
• Reproductive health issues that can interfere with study outcomes
• Smoking
• Metabolic syndrome (blood pressure, fasting glucose, fasting insulin and serum lipids measured to assess eligibility)
• Not on any hormonal medication that affects reproduction (including hormonal contraception)
• Hyperprolactinemia
• Abnormal thyroid stimulating hormone assay

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antral follicle diameter	Daily diameters of individual follicles ≥ 2mm from ultrasound examination	One menstrual cycle (21-35 days) per volunteer
Antral follicle count	Daily count of the number of follicles >2 mm from ultrasound examination	One menstrual cycle (21-35 days) per volunteer
Follicle stimulating hormone (FSH) serum level	Daily measurements of FSH in IU/L	One menstrual cycle (21-35 days) per volunteer
Luteinizing hormone (LH) serum level	Daily measurements of LH in IU/L	One menstrual cycle (21-35 days) per volunteer
Estradiol serum level	Daily measurements of estradiol in pg/mL	One menstrual cycle (21-35 days) per volunteer
Progesterone serum level	Daily measurements of progesterone in ng/mL	One menstrual cycle (21-35 days) per volunteer
Anti-mullerian hormone (AMH) serum level	Daily measurements of AMH in ng/mL	One menstrual cycle (21-35 days) per volunteer
Inhibin A serum level	Daily measurements of inhibin A in pg/mL	One menstrual cycle (21-35 days) per volunteer
Inhibin B serum level	Daily measurements of inhibin B in pg/mL	One menstrual cycle (21-35 days) per volunteer

Collaborators and Investigators

• Sponsor: University of Saskatchewan
• Collaborators: Ansh Labs
• Investigators: Principal Investigator: Angela R Baerwald, PhD,MD,CCFP, University of Saskatchewan

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2022
• Primary Completion (Actual): March 26, 2024
• Study Completion (Actual): March 26, 2024

Study Registration Dates

• First Submitted: August 29, 2022
• First Submitted That Met QC Criteria: September 2, 2022
• First Posted (Actual): September 7, 2022

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 15, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: ovulation; ovarian follicles
• Other Study ID Numbers: Bio 2080

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No