Insights in Endocervical Mucus Secretion
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Cervical mucus scores
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
Relugolix
Participants will take Reugolix for 10 days starting at the midluteal time point (6-9 days after "high fertility" based on ovulation test)
干预措施: Gonadotropin Releasing Hormone Antagonists Relugolix (Drug)
结局指标
主要结局
Cervical mucus scores
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
未报告次要终点
研究者
Leo Han
Principal Investigator
Oregon Health and Science University