Reproductive Issues
Conditions
Keywords
ovarian follicles, ovulation
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.
Interventions
DIAGNOSTIC_TESTTransvaginal 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.
Sponsors
Ansh Labs
University of Saskatchewan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Anti-mullerian hormone (AMH) serum level | One menstrual cycle (21-35 days) per volunteer | Daily measurements of AMH in ng/mL |
| Inhibin A serum level | One menstrual cycle (21-35 days) per volunteer | Daily measurements of inhibin A in pg/mL |
| Inhibin B serum level | One menstrual cycle (21-35 days) per volunteer | Daily measurements of inhibin B in pg/mL |
Countries
Canada
Outcome results
None listed