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Endometrial Fluid Study in Natural Cycles: a Prospective Observational Study

Sponsor
Anecova SA (Industry)
Overall Status
Completed
CT.gov ID
NCT03909230
Collaborator
(none)
30
Enrollment
1
Location
1.8
Actual Duration (Months)
16.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is designed to collect information about the characteristics of endometrial fluid at day 2 and day 4 post-ovulation in normal fertile women.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Implantation rates have stabilised around 35% in IVF and a current key rate limiting step is achieving successful implantation of the embryo. 1/3 of implantation failures are estimated to be caused by a problem with the receptivity of the endometrium. In recent years, several measurable parameters have been reported to assess endometrial receptivity. However, one parameter remains undescribed, the endometrial fluid viscosity.

    It is generally believed that the viscosity change post ovulation is influenced by the luteal phase endocrine milieu, and it is possible that the viscosity of the endometrial fluid has an impact on implantation.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Endometrial Fluid Study in Natural Cycles: a Prospective Observational Study
    Actual Study Start Date :
    Apr 2, 2019
    Actual Primary Completion Date :
    May 27, 2019
    Actual Study Completion Date :
    May 27, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    Day 2 post ovulation

    Ultrasound of the endometrium, Endometrial fluid sample, Blood sample
    Day 4 post ovulation

    Ultrasound of the endometrium, Endometrial fluid sample, Blood sample

    Outcome Measures

    Primary Outcome Measures

    1. Viscosity of endometrial fluid at D2 and D4 post ovulation of the normal cycle, respectively [4 days]

    Secondary Outcome Measures

    1. Plasma progesterone level [4 days]

    2. Plasma estradiol (E2) level [4 days]

    3. Endometrial thickness as measured by ultrasound [4 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Age: ≤ 35 years

    • Women eligible and qualified for egg donation at IVIRMA Bilbao

    • Proven fertile (having given birth to at least one spontaneously conceived normal child)

    • Signed written consent including sharing of anonymized data

    Exclusion Criteria:
    • Contraindications for egg donation according to IVIRMA Bilbao guidelines

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 IVIRMA Bilbao Leioa Vizcaya Spain 48940

    Sponsors and Collaborators

    • Anecova SA

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Anecova SA
    ClinicalTrials.gov Identifier:
    NCT03909230
    Other Study ID Numbers:
    • NCV-VIS-001
    First Posted:
    Apr 9, 2019
    Last Update Posted:
    Mar 18, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Mar 18, 2021