Physiologic Mechanisms Underlying Ovarian Follicular Waves During the Menstrual Cycle

Completed

• Conditions: Reproductive Issues

• Registration Number: NCT05531357
• Lead Sponsor: University of Saskatchewan

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.

Study Timeline

• Study First Submitted: 2022-08-29
• Study First Submitted QC: 2022-09-02
• Study First Posted: 2022-09-07
• Study Start: 2022-09-17
• Primary Completion: 2024-03-26
• Study Completion: 2024-03-26
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Saskatchewan; 🇨🇦 Saskatoon, Saskatchewan, Canada