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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04580056
Other study ID # Uterus Incision- Don
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date January 2022

Study information

Verified date October 2020
Source Assisting Nature
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A prospective randomised control trial of the impact of the fundus edometrial incision during hysteroscopy in oocyte recipients.


Description:

A prospective randomised control trial of the impact of the fundus edometrial incision during hysteroscopy in women without intrauterine pathology which is likely to have an adverse effect on reproductive outcomes. The study populations will be constituted by oocyte recipients.

Study group: Hysteroscopy with fundus endometrial incision Control group: Office Hysteroscopy without any endometrial injury


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 120
Est. completion date January 2022
Est. primary completion date January 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 30 Years to 50 Years
Eligibility Inclusion Criteria:

- oocyte acceptors

- age 30-50

- embryo transfer with Hormone Replacement Therapy

- embryo transfer within 6 months of hysteroscopy

Exclusion Criteria:

- previous uterine pathology

- sperm sample <1mil/ml

- leiomyoma

- septate uterus

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Uterine fundus endometrial incision during hysteroscopy
Uterine fundus endometrial scratching during hysteroscopy by incision

Locations

Country Name City State
Greece Assisting Nature Thessaloníki

Sponsors (2)

Lead Sponsor Collaborator
Assisting Nature 3rd Department of Obstetrics and Gynaecology, Aristotle University of Thessaloniki

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary Implantation Rate Implantation rate 6 weeks to 42 weeks after embryo transfer]
Primary Delivery Rate Delivery Rate 6 weeks to 42 weeks after embryo transfer]