Physiologic Mechanisms Underlying Ovarian Follicular Waves During the Menstrual Cycle

NCT05531357 | Completed

• 1 other identifier: Bio 2080
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Reproductive Issues

Keywords

ovarian follicles; ovulation

Outcome Measures

Primary Outcomes (9)

• 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

Interventions

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.

Also known as: Finger-prick blood sampling for dried blood spots, Urine sampling, Venipunctures

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Volunteers who respond to advertisements placed in the community, local offices and the University of Saskatchewan's website

You may qualify if:

• Healthy biological females
• Regular menstrual cycles (21-35 days)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Saskatchewan: lead
• Ansh Labs: collaborator

Study Sites (1)

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 5A2, Canada

Location

Related 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.

  PMID: 12849812 BACKGROUND

• 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.

  PMID: 12748128 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Dried blood spots, serum frozen at -80 C and dried urine spot samples

MeSH Terms

Interventions

Phlebotomy

Intervention Hierarchy (Ancestors)

Blood Specimen Collection; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Angela R Baerwald, PhD,MD,CCFP

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: September 7, 2022
• Study Start: September 17, 2022
• Primary Completion: March 26, 2024
• Study Completion: March 26, 2024
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)