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

NCT05161338 | Completed

• 1 other identifier: 2110-VLC-095-EL
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infertility, Female

Keywords

LUTHEAL PHASE SUPPORT; MICROBIOME; INFERTILITY; ONGOING PREGNANCY RATE; LIFE BIRTH RATE; ARTIFICIAL REPRODUCTION TREATMENT; EMBRYO TRANSFER

Outcome Measures

Primary Outcomes (1)

• Vaginal Microbiome

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

  12 months

Secondary Outcomes (5)

• Live birth

  12 months

• Ongoing Pregnancy Rate

  12 months

• Clinical Pregnancy

  12 months

• Serum progesterone value

  12 months

• Vaginal PH

  12 months

Study Arms (1)

FROZEN EMBRYO TRANSFER

EXPERIMENTAL

Women who undergo an artificial cycle for frozen embryo transfer and receive luteal phase support.

Diagnostic Test: MICROBIOME GENETIC ANALYSIS; Diagnostic Test: VAGINAL PH VALUE; Diagnostic Test: SERUM PROGESTERONE LEVELS; Diagnostic Test: SERUM OESTRADIOL LEVELS

Interventions

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

FROZEN EMBRYO TRANSFER

VAGINAL PH VALUE DIAGNOSTIC_TEST

Intravaginal Ph value meassurement.

FROZEN EMBRYO TRANSFER

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-.

FROZEN EMBRYO TRANSFER

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.

FROZEN EMBRYO TRANSFER

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Uterine Pathology, adnexal pathology
• Systemic diseases -

Sponsors & Collaborators

• Instituto Valenciano de Infertilidad, IVI VALENCIA: lead

Study Sites (1)

Ivi Valencia

Valencia, 46015, Spain

Location

MeSH Terms

Conditions

Infertility, Female; Infertility

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective cohort unicentric pilot study

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: December 17, 2021
• Study Start: February 15, 2022
• Primary Completion: March 1, 2023
• Study Completion: April 30, 2023
• Last Updated: October 24, 2023

Record last verified: 2023-10

Locations

ES (1)