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Completed

NCT Number: NCT05531357

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.

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Key information

Conditions

Reproductive Issues

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 5A2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transvaginal ultrasound scans

Diagnostic Test

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.

Other names: Finger-prick blood sampling for dried blood spots, Urine sampling, Venipunctures

Primary outcomes

  1. Antral follicle diameter

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

    Daily diameters of individual follicles ≥ 2mm from ultrasound examination

  2. 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

  3. Follicle stimulating hormone (FSH) serum level

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

    Daily measurements of FSH in IU/L

  4. Luteinizing hormone (LH) serum level

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

    Daily measurements of LH in IU/L

  5. Estradiol serum level

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

    Daily measurements of estradiol in pg/mL

  6. Progesterone serum level

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

    Daily measurements of progesterone in ng/mL

  7. Anti-mullerian hormone (AMH) serum level

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

    Daily measurements of AMH in ng/mL

  8. Inhibin A serum level

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

    Daily measurements of inhibin A in pg/mL

  9. Inhibin B serum level

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

    Daily measurements of inhibin B in pg/mL

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Collaborators

  • Ansh Labs

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 7, 2022
Registry last updated
May 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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