Physiologic Mechanisms Underlying Ovarian Follicular Waves During the Menstrual Cycle

Study Overview
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Brief Summary
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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
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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.

Official Title
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Physiologic Mechanisms Underlying Ovarian Follicular Waves During the Menstrual Cycle

Conditions
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Reproductive Issues

Intervention / Treatment
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* Diagnostic Test: Transvaginal ultrasound scans


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Transvaginal ultrasound scans|Transvaginal ultrasound scans to map ovarian follicle growth and ovulation, finger-prick blood sampling for dried blood spot (DBS) hormonal assays and urine sampling for hormone metabolites, every consecutive day for an interovulatory interval. Weekly venipuncture samples will be taken for standard ELISA hormonal assays. The hormones of interest are FSH, LH, estradiol, progesterone, AMH, inhibins A and B, GDF-9 and BMP-15.|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ovarian follicles, ovulation