NCT03398031

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2017

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 12, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

January 12, 2018

Status Verified

January 1, 2018

Enrollment Period

9 months

First QC Date

January 6, 2018

Last Update Submit

January 6, 2018

Conditions

ICSI

Outcome Measures

Primary Outcomes (1)

  • 1st trimesteric abortion

    Either spontaneous or missed abortion

    13 week of gestation

Study Arms (2)

Magnesium supplement

ACTIVE COMPARATOR

90 female pregnant after ICSI after biochemical diagnosis of pregnancy will receive 500 mg magnesium supplement

Drug: Magnesium Oxide

placebo

PLACEBO COMPARATOR

90 female pregnant after ICSI after biochemical diagnosis of pregnancy will receive placebo oral tablet

Drug: Placebo Oral Tablet

Interventions

Magnesium OxideDRUG

After biochemical diagnosis of pregnancy each participant will receive magnesium plus 500 mg tablet once daily till the end of the 1st trimester

Also known as: magnesium plus tablet
Magnesium supplement
Placebo Oral TabletDRUG

After biochemical diagnosis of pregnancy each participant will receive placebo tablet once daily till the end of the 1st trimester

placebo

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age 25\_38 years
  • BMI 25\_30
  • females pregnant after ICSI after biochemical diagnosis of pregnancy

You may not qualify if:

  • females with poor ovarian reserve and poor responders
  • abnormality in uterine cavity detected by hysteroscopic evaluation pre ICSI and not treated
  • hydrosalpinx

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AinShams university maternity hospital

Cairo, Abbassya, 02002, Egypt

RECRUITING

MeSH Terms

Interventions

Magnesium OxideMagnesiumTablets

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsOxidesOxygen CompoundsMetals, Alkaline EarthElementsMetals, LightMetalsDosage FormsPharmaceutical Preparations

Central Study Contacts

Radwa R Ali, MD

CONTACT

01283492979radwaebed@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

January 6, 2018

First Posted

January 12, 2018

Study Start

June 1, 2017

Primary Completion

March 1, 2018

Study Completion

June 1, 2018

Last Updated

January 12, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)