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

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:
  • magnesium plus tablet
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.

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

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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