Endometrial Scratch Injury in Women With Unexplained Infertility Undergoing IUI
Endometrial Scratch Injury Induced Higher Pregnancy Rate for Women With Unexplained Infertility Undergoing IUI With Ovarian Stimulation
1 other identifier
interventional
154
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2010
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 24, 2015
CompletedFirst Posted
Study publicly available on registry
January 29, 2015
CompletedJanuary 29, 2015
January 1, 2015
3 years
January 24, 2015
January 28, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
clinical pregnancy
14 days after IUI
Study Arms (2)
endometrial scratch injury
ACTIVE COMPARATORPatients 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. Group S had ESI using No.8 neonatal feeding tube and after 24 to 36 hours, IUI was performed.
Non endometrial scratch injury
NO INTERVENTIONPatients 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. Group C received IUI without ESI and after 24 to 36 hours, IUI was performed.
Interventions
Eligibility Criteria
You may qualify if:
- \. Couple with unexplained infertility and assigned for IUI
You may not qualify if:
- Woman's age of more than 40 years
- Ovarian cyst detected in the ultrasound examination
- Uterine lesions such as submucosal leiomyoma
- A previous diagnosis of moderate to severe pelvic endometriosis
- Women with body mass index ≥35 kg/m2 o
- Women with signs of hyperandrogenemia dy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Officials
- PRINCIPAL INVESTIGATOR
Ahmed M Maged, MD
Kasr Alainy medical school
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
January 24, 2015
First Posted
January 29, 2015
Study Start
January 1, 2010
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
January 29, 2015
Record last verified: 2015-01