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Recruiting NCT07111247

Insights in Endocervical Mucus Secretion

Phase IV Interventional Cervical Mucus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Gonadotropin Releasing Hormone Antagonists Relugolix.
Who it may be relevant to
Registry conditions: Cervical Mucus. Basic parameters: 21 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

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

  • Drug Gonadotropin Releasing Hormone Antagonists Relugolix
    Gonadotropin releasing hormone antagonist (gnRH) taken for 10 days starting during the midluteal phase.

Primary outcome measures

  • Cervical mucus scores [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 [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 [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])]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • Oregon Health & Science University — Portland

Identifiers

NCT: NCT07111247 · STUDY00028821 · R01HD115770-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗