Development of electrophysiological determination of uterine receptivity (EDUR) system: a performance evaluation test in multiparous women volunteers

JRCT ID: jRCTs052190056

Registered date:03/10/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: infertility
• Date of first enrollment: 09/11/2019
• Target sample size: 10
• Study type: Interventional
• Intervention(s): inserting uterine catheter with sensor to measure uterine bioelectrical impedance and oxidation-reduction potential

Outcome(s)

• Primary Outcome: correlation between measurement values of intrauterine bio-electrical impedance and intrauterine oxidation-reduction potential (ORP)

Secondary Outcome

alteration of intrauterine bio-electrical impedance measurements during menstrual cycle
safety evaluation (the incident rates of injury, bleeding, infection, and abdominal pain)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 45age old
• Gender: Female

Include criteria

(1) multiparous women.
(2) women aged over 20 years old and under 45 years old.
(3) women who have regular menstruation.
(4) women who can avoid getting pregnant during the period
(5) A written informed consent have to be obtained.

Exclude criteria

women;
(1) who are receiving hormone therapy
(2) who have not had menstruation yet since stopping hormone therapy
(3) who are pregnant
(4) who are during breastfeeding
(5) who can not visit to the hospital by following the schedule.
(6) who are considered ineligible for enrolling the study by a principal investigator

Related Information

• Primary Sponsor: Kimura Tadashi
• Secondary Sponsor: Nakamura Hitomi
• Source(s) of Monetary Support: Osaka University