Cervical Mucus
Conditions
Brief summary
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.
Detailed description
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).
Interventions
DRUGGonadotropin Releasing Hormone Antagonists Relugolix
Gonadotropin releasing hormone antagonist (gnRH) taken for 10 days starting during the midluteal phase.
Sponsors
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Oregon Health and Science University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
All participants will receive Relugolix for 10 days starting at the midluteal time point
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Normal menstrual cycles of 25-35 days in length for at least the previous 3 cycles * BMI \>18 and \<35 * Serum p4 \>= 3 ng/ml on single sample collected between days 18-25 of self-reported menstrual cycle * Flexible schedule allowing blood draws on less than 48 hour notice * In good general health * Commit to using non-hormonal contraceptive methods without spermicide during study period except those prescribed in the experimental protocol * No objections to taking study drugs * No objections to refraining from intercourse the night before any sampling and willing to use condoms during vaginal intercourse
Exclusion criteria
* Oral contraceptive use or other hormone supplement within the preceding 2 months * Current cervical infection * Evidence of abnormal cervical cytology * Use of any IUD for contraception * Long-acting hormonal contraceptive use in the past 12 months (e.g., Depo-Provera) * Contraindications to study drugs * Current or past pregnancy within the previous 6 months or currently trying to conceive * Desiring to conceive in the next 8 months * Breastfeeding in the past 2 months * Diagnosed diabetes or metabolic syndrome * Diagnosed Polycystic Ovary Syndrome * History of, or self-reported, substance abuse * Smoker * Previous infertility treatment excluding male factor issues * Use of an investigational drug within the past 2 months * History of excisional or ablative treatment procedure on cervix (i.e., LEEP, Cryotherapy, Cold Knife Cone) * Current treatment for a vaginal infection such as bacterial vaginosis * History of venous thromboembolism (VTE) or inherited thrombophilias
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cervical mucus scores | 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]) | Average cervical mucus scores at each study time point |
| Single cell transcriptome analysis | 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]) | Single cell transcriptome analysis comparing changes across menstrual time points |
| Proteomic analysis | 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 of mucus including Mucin concentration |
Countries
United States
Contacts
Primary ContactWomen's Health Research Unit Recruitment Line
Outcome results
None listed