Impact of Vaginal Microbiome on Vaginal Absorption of Exogenous Progesterone: a Pilot Study. (NCT05161338) | Clinical Trial Compass
CompletedNot Applicable
Impact of Vaginal Microbiome on Vaginal Absorption of Exogenous Progesterone: a Pilot Study.
Spain100 participantsStarted 2022-02-15
Plain-language summary
Is already demonstrated that around 30% of patients undergoing an artificial cycle with vaginal progesterone do not reach a minimum threshold value of serum progesterone levels on the day of embryo transfer. Women with serum progesterone levels below this threshold have 20% lower ongoing pregnancy and live birth rates, decreasing their chances of success. However, the cause of this high heterogeneity in exogenous vaginal progesterone absorption among our patients remains unknown. It has been suggested that vaginal microbiome, and vaginal pH (due to its impact in microbiota growth), may explain the differences in vaginal progesterone absorption. The aim of the present pilot study is to assess if certain vaginal conditions, such as its microbiome status or its pH level, might affect vaginal progesterone absorption (measured by serum progesterone levels) and, in turn, the chances of success. In order to evaluate it, a prospective cohort unicentric study will be conducted in IVI RMA Valencia (Spain). Infertile patients undergoing an embryo transfer in the context of an artificial cycle when using vaginal progesterone will be recruited. Serum progesterone and estradiol levels, microbiome genetic analysis in vaginal samples and vaginal pH will be measured both on the embryo transfer-scheduling day and on the embryo transfer day.
Who can participate
Age range
18 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The subject must provide written informed consent prior to any study related procedures
* Women ≤50 years old
* BMI ≤ 25 kg/m2
* Adequate endometrial thickness (\>6.5mm) and pattern (Triple A structure) in the proliferative phase
Exclusion Criteria:
* Uterine Pathology, adnexal pathology
* Systemic diseases -
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This was a pilot study looking at how vaginal bacteria might affect how well progesterone is absorbed — how might those findings be relevant to my own fertility treatment if I'm already using or considering vaginal progesterone?
2Since this study has already been completed, has my doctor seen or read any of its results, and do those results suggest that the type of vaginal microbiome someone has could change how effective vaginal progesterone is for supporting a pregnancy?
3If my vaginal microbiome turns out to play a role in progesterone absorption, is there any way to test or assess my microbiome before we decide how I should take progesterone during a fertility treatment cycle?
4Given that this was a pilot study — meaning it was a smaller, early-stage investigation — how confident should I be in applying its findings to my situation, and are there larger follow-up studies my doctor is aware of?
5Are there alternative routes for taking progesterone, such as oral or injectable, that might be worth discussing if there's any concern that vaginal absorption could be less reliable for me specifically?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Vaginal Microbiome
Timeframe: 12 months
Trial details
NCT IDNCT05161338
SponsorInstituto Valenciano de Infertilidad, IVI VALENCIA