Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07453069
Eligibility Criteria:
Inclusion Criteria:
1. Able to understand the study and sign a consent form.
2. Is a woman aged 18 to 40 years.
3. Still has regular menstrual periods (pre-menopausal).
4. Has had at least one previous frozen embryo transfer (FET) that did not result in pregnancy within the past 3 years, and this was not due to either male infertility or blocked /damaged fallopian tubes.
5. Planning to have a frozen embryo transfer (FET) using one good-quality embryo (grade 3BB or higher) and are considered medically suitable to proceed.
6. Willing to have only one embryo transferred during the study cycle.
7. A vaginal swab taken at the first study visit shows a specific vaginal microbiome imbalance required for this study (vaginal molecular dysbiosis).
8. An ultrasound scan shows no problems with uterus or pelvis that would prevent pregnancy or greatly reduce the chance of pregnancy.
9. Recent fertility blood tests (within the last 6 months) show:
* FSH less than 12 IU/L
* AMH greater than 1 ng/mL
10. Body mass index (BMI) is between 18 and 38 kg/m².
11. From the first study treatment until the mock FET cycle, agrees to:
* Avoid vaginal intercourse or use condoms (without spermicide or lubricant),
* Avoid swimming or hot tubs,
* Avoid using tampons, menstrual cups, sex toys, vaginal cleansers, lubricants, or other vaginal products unless approved by the study team.
12. Willing to answer questions about sexual and reproductive activity during the study.
13. Willing to provide vaginal swab samples at the clinic.
14. Willing to receive the first study treatment in the clinic and use the study treatment at home as instructed.
15. Screening blood tests are negative for hepatitis B, hepatitis C, HIV, and syphilis.
16. Willing to attend all study visits and follow-up assessments and provide information about pregnancy and newborn health outcomes.
Exclusion Criteria:
1. History of three or more failed frozen embryo transfers (FET) in the past 3 years.
2. Have a condition that weakens the immune system (such as uncontrolled diabetes, active cancer, or an organ transplant).
3. Currently taking medications that suppress the immune system (such as systemic steroids, biologics, chemotherapy, or transplant medications).
4. Is already pregnant before completing the mock FET cycle.
5. Test positive for a sexually transmitted infection (such as chlamydia, gonorrhea, Mycoplasma genitalium, or Trichomonas vaginalis).
6. Current vaginal yeast infection that requires treatment.
7. YCannot safely take the hormone medications required for a frozen embryo transfer (such as estradiol or progesterone).
8. Use of intravaginal progesterone gels or solutions.
9. Needs regular antibiotics or are likely to require antibiotics during the study.
10. Has taken oral, injectable, or vaginal antibiotics within 30 days before screening.
11. History of gynecological cancer or other significant gynecological condition that would make participation unsafe.
12. Has a medical condition that would make participation unsafe or difficult.
13. Has an unstable medical or psychiatric condition that could make it difficult to follow study requirements.
14. Has any other condition that could interfere with participation.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT07453069
Study Brief:
Protocol Section:
NCT07453069