Single arm interventional study looking at biological outcomes at 4 time points throughout the cycle before and after taking an oral gonadotropin-releasing hormone antagonist (gnRH). Samples of whole blood, endocervical mucus, endocervical biopsy, and vaginal swab will be collected.
This study will enroll participants and obtain biological samples at 4 time points. The study will begin on the first day of menstruation following enrollment. Patients will monitor for peri-ovulation using an ovulation test that monitors for urinary metabolites for luteinizing hormone (LH). At the midluteal time point for sampling (days 6-9 after "high fertility" on ovulation test) subjects will begin taking an oral gonadotropin-releasing hormone antagonist (gnRH) (relugolix) for 10 days. Samples of whole blood, endocervical mucus, endocervical biopsy, and vaginal swab will be collected during the early follicular phase (3-5 days following the start of menstruation), peri-ovulation (9-14 days following the start of menstruation based on estriol glucuronide (E3G) urinary metabolite), mid-luteal (6-9 days following mid-cycle draw), and upon stoppage of relugolix (9-11 days following relugolix initiation).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
15
Gonadotropin releasing hormone antagonist (gnRH) taken for 10 days starting during the midluteal phase.
Oregon Health & Science University
Portland, Oregon, United States
RECRUITINGCervical mucus scores
Average cervical mucus scores at each study time point
Time frame: Cervical mucus will be collected and compared across 4 time points during the menstrual cycle (follicular [3-5 days following start of menses], ovulatory, luteal, ovarian suppression [9-11 days following Relugolix initiation])
Single cell transcriptome analysis
Single cell transcriptome analysis comparing changes across menstrual time points
Time frame: Measured and compared across 4 time points during the menstrual cycle (follicular [3-5 days following start of menses], ovulatory, luteal, ovarian suppression [9-11 days following Relugolix initiation])
Proteomic analysis
Proteomic analysis of mucus including Mucin concentration
Time frame: Measured and compared across 4 time points during the menstrual cycle (follicular [3-5 days following start of menses], ovulatory, luteal, ovarian suppression [9-11 days following Relugolix initiation])
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