- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03398031
Effect of Magnesium Supplement in Early Pregnancy After ICSI
January 6, 2018 updated by: Radwa Rasheedy Ali, Ain Shams University
Magnesium Supplement in Early Pregnancy After ICSI
Daily supplement of magnesium after biochemical diagnosis of pregnancy in females pregnant after ICSI and through out 1st trimester
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
a fall of magnesium levels at 2-3 weeks of gestation. This drop of magnesium concentration is larger following IVF as compared to spontaneous pregnancies.
so magnesium supplement start after biochemical diagnosis of pregnancy and throughout the 1st trimester
Study Type
Interventional
Enrollment (Anticipated)
180
Phase
- Phase 3
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
-
-
Abbassya
-
Cairo, Abbassya, Egypt, 02002
- Recruiting
- AinShams university maternity hospital
-
Contact:
- ahmed m Abbas, MD
-
-
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
25 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- age 25_38 years
BMI 25_30
- females pregnant after ICSI after biochemical diagnosis of pregnancy
Exclusion Criteria:
females with poor ovarian reserve and poor responders
- abnormality in uterine cavity detected by hysteroscopic evaluation pre ICSI and not treated
- hydrosalpinx
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: Magnesium supplement
90 female pregnant after ICSI after biochemical diagnosis of pregnancy will receive 500 mg magnesium supplement
|
After biochemical diagnosis of pregnancy each participant will receive magnesium plus 500 mg tablet once daily till the end of the 1st trimester
Other Names:
|
Placebo Comparator: placebo
90 female pregnant after ICSI after biochemical diagnosis of pregnancy will receive placebo oral tablet
|
After biochemical diagnosis of pregnancy each participant will receive placebo tablet once daily till the end of the 1st trimester
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
1st trimesteric abortion
Time Frame: 13 week of gestation
|
Either spontaneous or missed abortion
|
13 week of gestation
|
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 (Actual)
June 1, 2017
Primary Completion (Anticipated)
March 1, 2018
Study Completion (Anticipated)
June 1, 2018
Study Registration Dates
First Submitted
January 6, 2018
First Submitted That Met QC Criteria
January 6, 2018
First Posted (Actual)
January 12, 2018
Study Record Updates
Last Update Posted (Actual)
January 12, 2018
Last Update Submitted That Met QC Criteria
January 6, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ashams university
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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