- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03824340
Intracytoplasmic Sperm Injection Preparation in Infertile Women
August 4, 2019 updated by: Aljazeera Hospital
Intracytoplasmic Sperm Injection Preparation in Infertile Women With Unexplained Infertility
Infertility is a common gynecological problem is women
Study Overview
Detailed Description
Intracytoplasmic sperm injection is one of the aisted reproduction techniques that help to solve this problem
Study Type
Interventional
Enrollment (Anticipated)
500
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Giza, Egypt
- Recruiting
- Algazeerah
-
-
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
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Women who have infertility with age between 20 -42 years
Exclusion Criteria:
- women who has ovarian or endometrial factor of infertility
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Doxycycline before ICSI
extra medications (Doxycycline ) group before ICSI : in which Women who will receive the Doxyxycline before ICSI Intervention : Women will receive Doxycycline before ICSI
|
Extra medication (Doxycycline ) group before ICSI :,women who will receive more medications (Doxycycline ) before starting the ICSI process
Other Names:
|
No Intervention: control group
control group : No intervention : in which Women willnot receive the extra medications (Doxycycline ) before ICSI
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the number of women who will have successful ICSI
Time Frame: within 4 months
|
The number of women who will get pregnant after ICSI with extra treatment
|
within 4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mahmoud Alalfy, PhD, Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
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 (Actual)
January 30, 2019
Primary Completion (Anticipated)
November 30, 2019
Study Completion (Anticipated)
January 1, 2020
Study Registration Dates
First Submitted
January 25, 2019
First Submitted That Met QC Criteria
January 29, 2019
First Posted (Actual)
January 31, 2019
Study Record Updates
Last Update Posted (Actual)
August 6, 2019
Last Update Submitted That Met QC Criteria
August 4, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ICSI preparation
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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