Physiologic Mechanisms Underlying Ovarian Follicular Waves During the Menstrual Cycle

NCT ID: NCT05531357

Last Updated: 2024-05-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-17
• Study Completion Date: 2024-03-26

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.

Conditions

Reproductive Issues

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Finger-prick blood sampling for dried blood spots; Urine sampling; Venipunctures

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ansh Labs

UNKNOWN

Sponsor Role: collaborator

University of Saskatchewan

OTHER

Sponsor Role: lead

Responsible Party

Angela Baerwald

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Angela R Baerwald, PhD,MD,CCFP

Role: PRINCIPAL_INVESTIGATOR

University of Saskatchewan

Locations

University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 12849812 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12748128 (View on PubMed)

Other Identifiers

Bio 2080

Identifier Type: -

Identifier Source: org_study_id