Endometrial FluidNCT03909230
Endometrial Fluid Study in Natural Cycles: a Prospective Observational Study
An observational study of Endometrial Fluid, run by Anecova SA at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Fluid
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 2 Apr 2019to 27 May 2019
- Phase
- Observational
- 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 Up to 35 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Women eligible and qualified as egg donors at IVIRMA Bilbao that meets the inclusion criteria
Who may be able to join
- 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
Who cannot join
- Contraindications for egg donation according to IVIRMA Bilbao guidelines
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Endometrial Fluid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Viscosity of endometrial fluid at D2 and D4 post ovulation of the normal cycle, respectively
Measured: 4 days
Secondary outcomes (3)
Plasma progesterone level
Measured: 4 days
Plasma estradiol (E2) level
Measured: 4 days
Endometrial thickness as measured by ultrasound
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start2 Apr 2019
- Primary completion27 May 2019
- Study completion27 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial FluidStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anecova SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03909230
- Sponsor's protocol ID
- NCV-VIS-001
- Status last verified
- Mar 2021
- First submitted
- 2 Apr 2019
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrial Fluid Study in Natural Cycles: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03909230
- Acronym / sponsor ID
- NCV-VIS-001
- Conditions
- Endometrial Fluid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Anecova SAIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2019 (actual)
- Primary completion
- 27 May 2019 (actual)
- Study completion
- 27 May 2019 (actual)
- First posted
- 9 Apr 2019 (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.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- Up to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Women eligible and qualified as egg donors at IVIRMA Bilbao that meets the inclusion criteria
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Contraindications for egg donation according to IVIRMA Bilbao guidelines
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Viscosity of endometrial fluid at D2 and D4 post ovulation of the normal cycle, respectively
Time frame: 4 days
3 secondary outcomes
Plasma progesterone level
Time frame: 4 days
Plasma estradiol (E2) level
Time frame: 4 days
Endometrial thickness as measured by ultrasound
Time frame: 4 days
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 18 Mar 2021.
- Individual participant dataSharing planned: No
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?
An observational study of Endometrial Fluid, run by Anecova SA 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 1 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 18 Mar 2021. 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?
Viscosity of endometrial fluid at D2 and D4 post ovulation of the normal cycle, respectively (time frame: 4 days). 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 18 Mar 2021; AzTrials last refreshed its copy on 1 Nov 2026.