Endometrial Fluid Study in Natural Cycles: a Prospective Observational Study

March 17, 2021 updated by: Anecova SA
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Vizcaya
      • Leioa, Vizcaya, Spain, 48940
        • IVIRMA Bilbao

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 35 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women eligible and qualified as egg donors at IVIRMA Bilbao that meets the inclusion criteria

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Viscosity of endometrial fluid at D2 and D4 post ovulation of the normal cycle, respectively
Time Frame: 4 days
4 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma progesterone level
Time Frame: 4 days
4 days
Plasma estradiol (E2) level
Time Frame: 4 days
4 days
Endometrial thickness as measured by ultrasound
Time Frame: 4 days
4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anecova SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2019

Primary Completion (Actual)

May 27, 2019

Study Completion (Actual)

May 27, 2019

Study Registration Dates

First Submitted

April 2, 2019

First Submitted That Met QC Criteria

April 8, 2019

First Posted (Actual)

April 9, 2019

Study Record Updates

Last Update Posted (Actual)

March 18, 2021

Last Update Submitted That Met QC Criteria

March 17, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • NCV-VIS-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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