Overview
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.
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).
Eligibility
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