- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02349750
Endometrial Scratch Injury in Women With Unexplained Infertility Undergoing IUI
January 28, 2015 updated by: Ahmed Maged, Cairo University
Endometrial Scratch Injury Induced Higher Pregnancy Rate for Women With Unexplained Infertility Undergoing IUI With Ovarian Stimulation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
154
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
1. Couple with unexplained infertility and assigned for IUI
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: endometrial scratch injury
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.
Group S had ESI using No.8 neonatal feeding tube and after 24 to 36 hours, IUI was performed.
|
ESI using No.8 neonatal feeding tube
|
No Intervention: Non endometrial scratch injury
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.
Group C received IUI without ESI and after 24 to 36 hours, IUI was performed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
clinical pregnancy
Time Frame: 14 days after IUI
|
14 days after IUI
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
January 1, 2013
Study Registration Dates
First Submitted
January 24, 2015
First Submitted That Met QC Criteria
January 28, 2015
First Posted (Estimate)
January 29, 2015
Study Record Updates
Last Update Posted (Estimate)
January 29, 2015
Last Update Submitted That Met QC Criteria
January 28, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 123 (Giresun University Scientific Research Project)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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