Clinical trial NCT05531357: Physiologic Mechanisms Underlying Ovarian Follicular Waves During the Menstrual Cycle
Official title: Physiologic Mechanisms Underlying Ovarian Follicular Waves During the Menstrual Cycle
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Reproductive Issues
Keywords: ovarian follicles
ovulation
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
Collaborators: name: Ansh Labs
First posted: 2022-09-07
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: Antral follicle diameter
timeFrame: One menstrual cycle (21-35 days) per volunteer
measure: Antral follicle count
timeFrame: One menstrual cycle (21-35 days) per volunteer
measure: Follicle stimulating hormone (FSH) serum level
timeFrame: One menstrual cycle (21-35 days) per volunteer
measure: Luteinizing hormone (LH) serum level
timeFrame: One menstrual cycle (21-35 days) per volunteer
measure: Estradiol serum level
timeFrame: One menstrual cycle (21-35 days) per volunteer
measure: Progesterone serum level
timeFrame: One menstrual cycle (21-35 days) per volunteer
measure: Anti-mullerian hormone (AMH) serum level
timeFrame: One menstrual cycle (21-35 days) per volunteer
measure: Inhibin A serum level
timeFrame: One menstrual cycle (21-35 days) per volunteer
measure: Inhibin B serum level
timeFrame: One menstrual cycle (21-35 days) per volunteer
Secondary outcomes:
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Angela R Baerwald, PhD,MD,CCFP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.