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Clinical Trials/NCT05531357
NCT05531357
Completed
Not Applicable

Physiologic Mechanisms Underlying Ovarian Follicular Waves During the Menstrual Cycle

University of Saskatchewan1 site in 1 country50 target enrollmentSeptember 17, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Reproductive Issues
Sponsor
University of Saskatchewan
Enrollment
50
Locations
1
Primary Endpoint
Antral follicle diameter
Status
Completed
Last Updated
last year

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
September 17, 2022
End Date
March 26, 2024
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Angela Baerwald

Associate Professor

University of Saskatchewan

Eligibility Criteria

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
  • 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

Outcomes

Primary Outcomes

Antral follicle diameter

Time Frame: One menstrual cycle (21-35 days) per volunteer

Daily diameters of individual follicles ≥ 2mm from ultrasound examination

Antral follicle count

Time Frame: One menstrual cycle (21-35 days) per volunteer

Daily count of the number of follicles \>2 mm from ultrasound examination

Anti-mullerian hormone (AMH) serum level

Time Frame: One menstrual cycle (21-35 days) per volunteer

Daily measurements of AMH in ng/mL

Inhibin B serum level

Time Frame: One menstrual cycle (21-35 days) per volunteer

Daily measurements of inhibin B in pg/mL

Follicle stimulating hormone (FSH) serum level

Time Frame: One menstrual cycle (21-35 days) per volunteer

Daily measurements of FSH in IU/L

Luteinizing hormone (LH) serum level

Time Frame: One menstrual cycle (21-35 days) per volunteer

Daily measurements of LH in IU/L

Estradiol serum level

Time Frame: One menstrual cycle (21-35 days) per volunteer

Daily measurements of estradiol in pg/mL

Progesterone serum level

Time Frame: One menstrual cycle (21-35 days) per volunteer

Daily measurements of progesterone in ng/mL

Inhibin A serum level

Time Frame: One menstrual cycle (21-35 days) per volunteer

Daily measurements of inhibin A in pg/mL

Study Sites (1)

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