Back to resultsIntracytoplasmic Sperm Injection Preparation in Infertile Women
Primary Purpose
Infertility
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Doxycycline before ICSI
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility Criteria
Inclusion Criteria:
- Women who have infertility with age between 20 -42 years
Exclusion Criteria:
- women who has ovarian or endometrial factor of infertility
Sites / Locations
- AlgazeerahRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Doxycycline before ICSI
control group
Arm Description
extra medications (Doxycycline ) group before ICSI : in which Women who will receive the Doxyxycline before ICSI Intervention : Women will receive Doxycycline before ICSI
control group : No intervention : in which Women willnot receive the extra medications (Doxycycline ) before ICSI
Outcomes
Primary Outcome Measures
the number of women who will have successful ICSI
The number of women who will get pregnant after ICSI with extra treatment
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03824340
Brief Title
Intracytoplasmic Sperm Injection Preparation in Infertile Women
Official Title
Intracytoplasmic Sperm Injection Preparation in Infertile Women With Unexplained Infertility
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 30, 2019 (Actual)
Primary Completion Date
November 30, 2019 (Anticipated)
Study Completion Date
January 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aljazeera Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Infertility is a common gynecological problem is women
Detailed Description
Intracytoplasmic sperm injection is one of the aisted reproduction techniques that help to solve this problem
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized controlled study
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Doxycycline before ICSI
Arm Type
Active Comparator
Arm Description
extra medications (Doxycycline ) group before ICSI : in which Women who will receive the Doxyxycline before ICSI Intervention : Women will receive Doxycycline before ICSI
Arm Title
control group
Arm Type
No Intervention
Arm Description
control group : No intervention : in which Women willnot receive the extra medications (Doxycycline ) before ICSI
Intervention Type
Drug
Intervention Name(s)
Doxycycline before ICSI
Other Intervention Name(s)
Medical treatment with Doxycycline
Intervention Description
Extra medication (Doxycycline ) group before ICSI :,women who will receive more medications (Doxycycline ) before starting the ICSI process
Primary Outcome Measure Information:
Title
the number of women who will have successful ICSI
Description
The number of women who will get pregnant after ICSI with extra treatment
Time Frame
within 4 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
infertile women
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women who have infertility with age between 20 -42 years
Exclusion Criteria:
women who has ovarian or endometrial factor of infertility
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud Alalfy, PhD
Phone
01002611058
Email
mahmoudalalfy@ymail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud Alalfy, PhD
Organizational Affiliation
Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Algazeerah
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahmoud Alalfy, master
Phone
+201002611058
Email
mahmoudalalfy@ymail.com
First Name & Middle Initial & Last Name & Degree
Ahmed Elgazzar, M.D
Phone
+201014005959
First Name & Middle Initial & Last Name & Degree
Mahmoud Alalfy, master
12. IPD Sharing Statement
Learn more about this trial
Intracytoplasmic Sperm Injection Preparation in Infertile Women
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