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Completed

NCT Number: NCT05161338

Impact of Vaginal Microbiome on Vaginal Absorption of Exogenous Progesterone: a Pilot 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.

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Key information

Conditions

Infertility, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ivi Valencia

Valencia, 46015, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

MICROBIOME GENETIC ANALYSIS

Diagnostic 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 VALUE

Diagnostic Test

Intravaginal Ph value meassurement.

SERUM PROGESTERONE LEVELS

Diagnostic 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 LEVELS

Diagnostic 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.

Primary outcomes

  1. Vaginal Microbiome

    Time frame: 12 months

    Result of the microbiome genetic analysis in vaginal samples (nucleic acid extraction and genetic analysis)

Secondary outcomes

  1. Live birth

    Time frame: 12 months

    Live birth rate

  2. Ongoing Pregnancy Rate

    Time frame: 12 months

    Success value in pregnancy after ultrasound confirmation of heartbeat and 12 weeks of pregnancy

  3. Clinical Pregnancy

    Time frame: 12 months

    Pregnancy confirmation by the observation of the presence of at least one gestational sac on ultrasound

  4. Serum progesterone value

    Time frame: 12 months

    Serum progesterone levels

  5. Vaginal PH

    Time frame: 12 months

    Measure of vaginal pH levels

Sponsors and collaborators

Lead sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

Other

Registry information

Acronym: PROGEBIOMA

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 17, 2021
Registry last updated
Oct 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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