Endometrial Scratch Injury in Women With Unexplained Infertility Undergoing IUI

Unexplained Infertility Clinical Trial

Official title:

Endometrial Scratch Injury Induced Higher Pregnancy Rate for Women With Unexplained Infertility Undergoing IUI With Ovarian Stimulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02349750
• Other study ID #: 123
• Status: Completed
• Phase: N/A
• First received: January 24, 2015
• Last updated: January 28, 2015
• Start date: January 2010
• Est. completion date: January 2013

Study information

• Verified date: January 2015
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

The study included 154 infertile women Patients received 100 mg of oral clomiphene citrate for five days starting on day 3 of the menstrual cycle, followed by daily injection of 150 IU of hMG and when more than two dominant follicles reached a diameter of 17 mm 5,000 IU of hCG was injected intramuscularly. Patients were randomly allocated into two equal groups: Group C received IUI without ESI and Group S had ESI using No.8 neonatal feeding tube and after 24 to 36 hours, IUI was performed. Successful pregnancy was con-firmed by ultrasound and patients had failed trial underwent another trial of IUI for a maximum of three trials.

Description:

The study included 154 infertile women with mean duration of infertility of 3.9±0.4 years. Patients received 100 mg of oral clomiphene citrate for five days starting on day 3 of the menstrual cycle, followed by daily injection of 150 IU of hMG and when more than two dominant follicles reached a diameter of 17 mm 5,000 IU of hCG was injected intramuscularly. Patients were randomly allocated into two equal groups: Group C received IUI without ESI and Group S had ESI using No.8 neonatal feeding tube and after 24 to 36 hours, IUI was performed. Successful pregnancy was con-firmed by ultrasound and patients had failed trial underwent another trial of IUI for a maximum of three trials.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Couple with unexplained infertility and assigned for IUI

Exclusion Criteria:

1. Woman's age of more than 40 years

2. Ovarian cyst detected in the ultrasound examination

3. Uterine lesions such as submucosal leiomyoma

4. A previous diagnosis of moderate to severe pelvic endometriosis

5. Women with body mass index =35 kg/m2 o

6. Women with signs of hyperandrogenemia dy

Study Design

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

Related Conditions & MeSH terms

• Infertility
• Unexplained Infertility

Intervention

Procedure:
• endometrial scratch injury
ESI using No.8 neonatal feeding tube

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical pregnancy		14 days after IUI	No