Physiologic Mechanisms Underlying Ovarian Follicular Waves During the Menstrual Cycle

Reproductive Issues Clinical Trial

Official title:

Physiologic Mechanisms Underlying Ovarian Follicular Waves During the Menstrual Cycle

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05531357
• Other study ID #: Bio 2080
• Status: Completed
• Start date: September 17, 2022
• Est. completion date: March 26, 2024

Study information

• Verified date: May 2024
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 26, 2024
• Est. primary completion date: March 26, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Reproductive Issues

Intervention

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.

Locations

Country	Name	City	State
Canada	University of Saskatchewan	Saskatoon	Saskatchewan

Sponsors (2)

Lead Sponsor	Collaborator
University of Saskatchewan	Ansh Labs

Country where clinical trial is conducted

Canada, 

References & Publications (2)

Baerwald AR, Adams GP, Pierson RA. A new model for ovarian follicular development during the human menstrual cycle. Fertil Steril. 2003 Jul;80(1):116-22. doi: 10.1016/s0015-0282(03)00544-2. — View Citation

Baerwald AR, Adams GP, Pierson RA. Characterization of ovarian follicular wave dynamics in women. Biol Reprod. 2003 Sep;69(3):1023-31. doi: 10.1095/biolreprod.103.017772. Epub 2003 May 14. — View Citation

Outcome

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