Effect of Magnesium Supplement in Early Pregnancy After ICSI

Phase 3

• Conditions: ICSI
• Interventions: Drug: Magnesium Oxide; Drug: Placebo Oral Tablet

• Registration Number: NCT03398031
• Lead Sponsor: Ain Shams University

Brief Summary

Daily supplement of magnesium after biochemical diagnosis of pregnancy in females pregnant after ICSI and through out 1st trimester

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 Timeline

• Study Start: 2017-06-01
• Status Verified: 2018-01
• Study First Submitted: 2018-01-06
• Study First Submitted QC: 2018-01-06
• Last Update Submitted: 2018-01-06
• Study First Posted: 2018-01-12
• Last Update Posted: 2018-01-12
• Primary Completion: 2018-03-01
• Study Completion: 2018-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnesium supplement	Magnesium Oxide	90 female pregnant after ICSI after biochemical diagnosis of pregnancy will receive 500 mg magnesium supplement
placebo	Placebo Oral Tablet	90 female pregnant after ICSI after biochemical diagnosis of pregnancy will receive placebo oral tablet

Primary Outcome Measures

Name	Time	Method
1st trimesteric abortion	13 week of gestation	Either spontaneous or missed abortion

Trial Locations

Locations (1)

AinShams university maternity hospital; 🇪🇬 Cairo, Abbassya, Egypt