Value of Routine Hysteroscopy Prior to IVF/ICSI Cycles

Infertility Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02245750
• Other study ID #: Routine Hysterscopy
• Status: Recruiting
• Phase: N/A
• First received: April 24, 2014
• Last updated: September 19, 2014
• Start date: August 2014
• Est. completion date: February 2015

Study information

• Verified date: September 2014
• Source: Ain Shams Maternity Hospital
• Contact: Ahmed M Mohammed, MbbcH
• Phone: 00201110362860
• Email: ahmadmarzok85[@]gmail.com
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

In the current study the investigators hypothesize that Routine Hysteroscopy prior to IVF/ICSI cycle increases the clinical pregnancy rate.

Description:

A randomized controlled study involving 300 patients with recurrent implantation failure

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: February 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Patient's age ranged from 20-40 years.

2. Normal appearance of the uterine cavity on hysterosalpingography.

3. Patients prepared for IVF/ICSI cycle.

Exclusion Criteria:

1. Patients who have any contraindications for hysteroscopy. (Menstruation, pregnancy, severe vaginitis or cervicitis, endometrial infection and history of Pelvic Inflammatory Diseases).

2. Patients with uterine cavity pathology previously known to the examiner.

3. Patients with previous uterine surgery such as myomectomy.

4. Patients with abnormal HSG.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Device:
• Hysteroscopy
hysteroscopy and endometrial injury prior to the IVF/ICSI cycle

Locations

Country	Name	City	State
Egypt	Ain Shams Maternity hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	• Uterine anomalies detected by Hysteroscopy		6 months	No
Primary	• Clinical pregnancy rate.		6 months	No
Secondary	• Live Birth Rate		6 months	No