Infertility, FemalePROGEBIOMANCT05161338
Impact of Vaginal Microbiome on Vaginal Absorption of Exogenous Progesterone: a Pilot Study.
A study testing MICROBIOME GENETIC ANALYSIS, VAGINAL PH VALUE and SERUM PROGESTERONE LEVELS in people with Infertility, Female, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- MICROBIOME GENETIC ANALYSIS, VAGINAL PH VALUE and SERUM PROGESTERONE LEVELS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 15 Feb 2022to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Uterine Pathology, adnexal pathology
- Systemic diseases -
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Currently, as part of routine clinical practice serum progesterone levels were meassured of women undergoing an ET in the context of an artificial cycle. These blood tests are usually performed around 2 hours before ET, thus results are available before their departure of the clinic. In the event of detecting low serum progesterone levels, an extra dose of exogenous subcutaneous progesterone is given for LPS.
There is not knowing about the reason of this heterogeneity in progesterone absorption, and one plausible hypothesis is vaginal microbiome. In the event of proving a significant association between vaginal microbiome and serum progesterone levels on the day of ET, and in particular if these levels are below or above the delimited threshold, it would be possible to individualize LPS in several patients in a more direct manner.
It is true that our current clinical practice, giving subcutaneous progesterone, is capable of equaling OPR of women with serum progesterone levels below 8.8 ng/ml on the ET day to those with values above this threshold applying the exact same approach to all patients. This study could be the next step towards an iLPS, to know the reason of the lower progesterone levels, and treat it directly, instead of moving to the need of a daily injection of progesterone which is costly and not patient friendly. Furthermore, vaginal microbiome may also have an impact in the subsequent OPR, even though serum progesterone levels were over 8.8 ng/ml. If this is the case, the analisys in advance the patient's vaginal microbiome will allow to treat the patient accordingly in order to increase the results of the ART treatment.
- Conditions
- Infertility, Female
- Being tested
- MICROBIOME GENETIC ANALYSIS, VAGINAL PH VALUE, SERUM PROGESTERONE LEVELS, SERUM OESTRADIOL LEVELS
- Keywords
- LUTHEAL PHASE SUPPORT, MICROBIOME, INFERTILITY, ONGOING PREGNANCY RATE, LIFE BIRTH RATE, ARTIFICIAL REPRODUCTION TREATMENT, EMBRYO TRANSFER
- Medical subject headings
- Infertility, Female, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MICROBIOME GENETIC ANALYSISDiagnostic test
Vaginal samples will be taken. A floxed nylon swab will be rotated against the posterior vaginal wall, Nucleic acid extraction and genetic analisys will be performed
VAGINAL PH VALUEDiagnostic test
Intravaginal Ph value meassurement.
SERUM PROGESTERONE LEVELSDiagnostic test
Determination of serum P4 levels On the day of embryo transfer scheduling (prior to the onset of exogenous progesterone administration) and on the embryo transfer day-.
SERUM OESTRADIOL LEVELSDiagnostic test
Determination of serum E2 levels On the day of embryo transfer scheduling (prior to the onset of exogenous progesterone administration) and on the embryo transfer day.
| Study group | Role | What they receive |
|---|---|---|
| FROZEN EMBRYO TRANSFER | Experimental | Women who undergo an artificial cycle for frozen embryo transfer and receive luteal phase support. Receives: Diagnostic Test: MICROBIOME GENETIC ANALYSIS; Diagnostic Test: VAGINAL PH VALUE; Diagnostic Test: SERUM PROGESTERONE LEVELS; Diagnostic Test: SERUM OESTRADIOL LEVELS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal Microbiome
Result of the microbiome genetic analysis in vaginal samples (nucleic acid extraction and genetic analysis)
Measured: 12 months
Secondary outcomes (5)
Live birth
Live birth rate
Measured: 12 months
Ongoing Pregnancy Rate
Success value in pregnancy after ultrasound confirmation of heartbeat and 12 weeks of pregnancy
Measured: 12 months
Clinical Pregnancy
Pregnancy confirmation by the observation of the presence of at least one gestational sac on ultrasound
Measured: 12 months
Serum progesterone value
Serum progesterone levels
Measured: 12 months
Vaginal PH
Measure of vaginal pH levels
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start15 Feb 2022
- Primary completion1 Mar 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective cohort unicentric pilot study
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161338
- Sponsor's protocol ID
- 2110-VLC-095-EL
- Acronym
- PROGEBIOMA
- Status last verified
- Oct 2023
- First submitted
- 15 Dec 2021
- Last updated
- 24 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Vaginal Microbiome on Vaginal Absorption of Exogenous Progesterone: a Pilot Study.
- ClinicalTrials.gov ID
- NCT05161338
- Acronym / sponsor ID
- PROGEBIOMA / 2110-VLC-095-EL
- Conditions
- Infertility, Female
- Keywords
- LUTHEAL PHASE SUPPORT, MICROBIOME, INFERTILITY, ONGOING PREGNANCY RATE, LIFE BIRTH RATE, ARTIFICIAL REPRODUCTION TREATMENT, EMBRYO TRANSFER
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 17 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Currently, as part of routine clinical practice serum progesterone levels were meassured of women undergoing an ET in the context of an artificial cycle. These blood tests are usually performed around 2 hours before ET, thus results are available before their departure of the clinic. In the event of detecting low serum progesterone levels, an extra dose of exogenous subcutaneous progesterone is given for LPS.
There is not knowing about the reason of this heterogeneity in progesterone absorption, and one plausible hypothesis is vaginal microbiome. In the event of proving a significant association between vaginal microbiome and serum progesterone levels on the day of ET, and in particular if these levels are below or above the delimited threshold, it would be possible to individualize LPS in several patients in a more direct manner.
It is true that our current clinical practice, giving subcutaneous progesterone, is capable of equaling OPR of women with serum progesterone levels below 8.8 ng/ml on the ET day to those with values above this threshold applying the exact same approach to all patients. This study could be the next step towards an iLPS, to know the reason of the lower progesterone levels, and treat it directly, instead of moving to the need of a daily injection of progesterone which is costly and not patient friendly. Furthermore, vaginal microbiome may also have an impact in the subsequent OPR, even though serum progesterone levels were over 8.8 ng/ml. If this is the case, the analisys in advance the patient's vaginal microbiome will allow to treat the patient accordingly in order to increase the results of the ART treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective cohort unicentric pilot study
| Arm | Type | Receives |
|---|---|---|
| FROZEN EMBRYO TRANSFER | Experimental | Diagnostic Test: MICROBIOME GENETIC ANALYSIS, Diagnostic Test: VAGINAL PH VALUE, Diagnostic Test: SERUM PROGESTERONE LEVELS, Diagnostic Test: SERUM OESTRADIOL LEVELSWomen who undergo an artificial cycle for frozen embryo transfer and receive luteal phase support. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Uterine Pathology, adnexal pathology
- Systemic diseases -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MICROBIOME GENETIC ANALYSISVaginal samples will be taken. A floxed nylon swab will be rotated against the posterior vaginal wall, Nucleic acid extraction and genetic analisys will be performed | Diagnostic test | FROZEN EMBRYO TRANSFER |
| VAGINAL PH VALUEIntravaginal Ph value meassurement. | Diagnostic test | FROZEN EMBRYO TRANSFER |
| SERUM PROGESTERONE LEVELSDetermination of serum P4 levels On the day of embryo transfer scheduling (prior to the onset of exogenous progesterone administration) and on the embryo transfer day-. | Diagnostic test | FROZEN EMBRYO TRANSFER |
| SERUM OESTRADIOL LEVELSDetermination of serum E2 levels On the day of embryo transfer scheduling (prior to the onset of exogenous progesterone administration) and on the embryo transfer day. | Diagnostic test | FROZEN EMBRYO TRANSFER |
Primary outcome
Vaginal Microbiome
Time frame: 12 months
Result of the microbiome genetic analysis in vaginal samples (nucleic acid extraction and genetic analysis)
5 secondary outcomes
Live birth
Time frame: 12 months
Ongoing Pregnancy Rate
Time frame: 12 months
Clinical Pregnancy
Time frame: 12 months
Serum progesterone value
Time frame: 12 months
Vaginal PH
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MICROBIOME GENETIC ANALYSIS, VAGINAL PH VALUE and SERUM PROGESTERONE LEVELS in people with Infertility, Female, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal Microbiome (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2023.