Investigating the effect of magnesium in solving the problem of frequent implantation failure in IVF
Design
The samples are selected by easy sampling and then randomly assigned to intervention and control groups by Randomized Allocation method. The estimated sample size is determined with the advice of a statistician and using a formula, taking into account a 10% dropout of 30 people in each group. This study is a double-blind study where the patient and the researcher do not know about the procedure.
Settings and conduct
All women referred to Shahrekord infertility clinic with a history of repeated implantation failure are studied. This study is a double-blind study where the patient and the researcher do not know about the procedure. Medicines will be pre-prepared with labels A and B, which will be delivered to the case and control groups.
Participants/Inclusion and exclusion criteria
women referred to Shahrekord infertility clinic with a history of repeated implantation failure
Intervention groups
For patients in the case group, one magnesium citrate tablet will be prescribed for two months, daily.
Then, before the intervention and at intervals of one month and two months (after the start of the drug) ultrasound will be taken and the number of uterine contractions will be checked and recorded for at least 15 minutes.
Also, at the mentioned intervals (before the intervention and at intervals of one month and two months later), the level of magnesium in the blood will be measured and recorded with the same kit in the same laboratory. After two months, IVF will be done. After 14 days, BhCG will be measured to measure successful implantation. Then, after one month, ultrasound (again by the researcher) will be performed to confirm the intrauterine pregnancy sac.
Main outcome variables
Magnesium level
Number of uterine contractions
Study group
IVF result
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230304057611N1
Registration date:2023-11-04, 1402/08/13
Registration timing:prospective
Last update:2023-11-04, 1402/08/13
Update count:0
Registration date
2023-11-04, 1402/08/13
Registrant information
Name
Maryam Eslami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3322 3883
Email address
eslmaryam@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-06, 1402/09/15
Expected recruitment end date
2024-05-21, 1403/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of magnesium on uterine contractions in woman with repeated implantation failure referred to infertility clinic
Public title
Investigating the effect of magnesium on uterine contractions in woman with repeated implantation failure referred to infertility clinic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Three unsuccessful IVF attempts ( negative BhCG )
Willingness to try next IVF
Normal karyotype
Normal level of LH, FSH, prolactin and TSH
Exclusion criteria:
Patient's refusal to continue treatment
Any sensitivity or intolerance to magnesium
Existence of systemic disease affecting infertility
Presence of structural disease of the uterus
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The researcher assigns a number to the patients using the random allocation rule method and then puts the cards on which the patient's number is written in an envelope in a shuffle. In this method, according to the size of the sample, two color cards, red and blue or labeled A and B, with the same number equal to the total size of the sample (60) are put inside the envelope, then the qualified people who participants in the study will randomly remove one of the cards from the envelope and according to the researcher's definition, if they pick up the red or A card, they will enter the intervention group (30) and if they pick up the blue or B card, they will enter the control group (30).
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient and the researcher do not know about the procedure. Medicines will be pre-prepared with labels A and B, which will be categorized and prepared by the statistics consultant and delivered to the case and control groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahrekord University of Medical Sciences
Street address
Hajar Hospital.,Parastar Ave., Kashani Blvd ., Shahrekord Town
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Approval date
2023-03-05, 1401/12/14
Ethics committee reference number
IR.SKUMS.MRD.REC.1401.064
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Magnesium level
Timepoint
before the intervention and at intervals of one month and two months later
Method of measurement
Lab Kit
Secondary outcomes
1
Description
IVF result
Timepoint
After 14 days of doing IVF
Method of measurement
BHCG lab kit
Intervention groups
1
Description
Intervention group: One daily magnesium citrate tablet (300 mg, Sajpod company) for two months.
Category
Treatment - Drugs
2
Description
Control group: For the patients of the control group, a placebo pill supplied by the same pill manufacturing company (without any special medicine) will be prescribed for two months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Fertility clinic and infertility center Shahrekord
Full name of responsible person
Dr. Maryam Nemati
Street address
Fertility clinic and infertility center of Shahrekord .,East Sa'di Ave
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3333 0061
Email
info@skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Elham Raeisi
Street address
, university headquarters., Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3334 2414
Email
vcrt@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr.Maryam Eslami
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hajar Hospital , Parastar Ave., Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3322 5505
Email
eslmaryam@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr.Maryam Eslami
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hajar Hospital , Parastar Ave., Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3322 5505
Email
eslmaryam@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr.Maryam Eslami
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hajar Hospital , Parastar Ave., Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3322 5505
Email
eslmaryam@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
no more information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available