Endometrial Fluid Study in Natural Cycles: a Prospective Observational Study

Endometrial Fluid Clinical Trial

Official title:

Endometrial Fluid Study in Natural Cycles: a Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03909230
• Other study ID #: NCV-VIS-001
• Status: Completed
• Start date: April 2, 2019
• Est. completion date: May 27, 2019

Study information

• Verified date: March 2021
• Source: Anecova SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 27, 2019
• Est. primary completion date: May 27, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Fluid

Locations

Country	Name	City	State
Spain	IVIRMA Bilbao	Leioa	Vizcaya

Sponsors (1)

Lead Sponsor	Collaborator
Anecova SA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viscosity of endometrial fluid at D2 and D4 post ovulation of the normal cycle, respectively		4 days
Secondary	Plasma progesterone level		4 days
Secondary	Plasma estradiol (E2) level		4 days
Secondary	Endometrial thickness as measured by ultrasound		4 days