NCT03909230

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

April 2, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 9, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2019

Completed
Last Updated

March 18, 2021

Status Verified

March 1, 2021

Enrollment Period

2 months

First QC Date

April 2, 2019

Last Update Submit

March 17, 2021

Conditions

Endometrial Fluid

Outcome Measures

Primary Outcomes (1)

  • Viscosity of endometrial fluid at D2 and D4 post ovulation of the normal cycle, respectively

    4 days

Secondary Outcomes (3)

  • Plasma progesterone level

    4 days

  • Plasma estradiol (E2) level

    4 days

  • Endometrial thickness as measured by ultrasound

    4 days

Study Arms (2)

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

Eligibility Criteria

AgeUp to 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Contraindications for egg donation according to IVIRMA Bilbao guidelines

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IVIRMA Bilbao

Leioa, Vizcaya, 48940, Spain

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2019

First Posted

April 9, 2019

Study Start

April 2, 2019

Primary Completion

May 27, 2019

Study Completion

May 27, 2019

Last Updated

March 18, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)