The effect of Ginger in increasing endometrial thickness among the referred infertile female IUI candidates with thin endometrium to infertility department of Yas Hospital
In a double blind randomized clinical trial 155 patients in the Case group recieve Ginger 250 mg tablets once a day for a month before IUI cycle, meanwhile the Control group recieves placebo. On the first day of the next menustral cycle, ovulation induction is started by letrozole for 5 days along with 3 HMG 75mg /daily. Endometrial thickness is measured via vaginal ultrasound when mature follicles are >18mm. rhCG 250µg for trigger is then injected. IUI is done 36 hours later for both groups. chemical pregnancy is confirmed by positive BhCG at day 14 after the trigger. Clinical pregnancy is confirmed at week 6 by vaginal ultrasound. Then ongoing pregnancy and take-home baby will be evaluated.
Design
Patients who use tablet placebo once a day for one month before IUI cycle(N=155)
Settings and conduct
This randomized double blind placeho Controlled is Conducted at Yas hospital of Tehran University of medical sciences at Ivf Clinic, after informed Consent is Signed by patients, 310 patients randomly assigned in Case orControl group. Patients & physicians are blinded regarding groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients who are Candidate for IUI with endometrial thickness<7mm in vaginal ultrasound; at least one patent tube at hystero Salpingography
Exclusion criteria: hypertension;diabetes; any underlying or endocrinological disease; hypersensitivity to ginger; age>40y; AMH <1
Intervention groups
Patients who use tablet ginger 250mg once a day for one month before IUI cycle(N=155)
Main outcome variables
positive BhCG at 14th day after IUI; visualisation of fetal heart at 6 weeks in vaginal ultrasound; ongoing pregnancy; take home baby
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091012002576N23
Registration date:2022-02-17, 1400/11/28
Registration timing:registered_while_recruiting
Last update:2022-02-17, 1400/11/28
Update count:0
Registration date
2022-02-17, 1400/11/28
Registrant information
Name
Fatemeh Davari Tanha
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8831 3955
Email address
fdavaritanha@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-16, 1400/11/27
Expected recruitment end date
2022-10-19, 1401/07/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Ginger in increasing endometrial thickness among the referred infertile female IUI candidates with thin endometrium to infertility department of Yas Hospital
Public title
The effect of Ginger on endometrial thickness in IUI cycle with thin endometrium
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are Candidate for IUI with endometrial thickness<7mm in vaginal ultrasound
At least one tubal patency at hSG
Exclusion criteria:
Hypertension
Diabetes
Any endocrinological or underlying disease
Hypersensitivity to ginger
AMH<1
Age
From 18 years old to 39 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
310
Randomization (investigator's opinion)
Randomized
Randomization description
In Random allocation rule: First 155 letters A and 155 letters B are written on special papers that are not marked inside. Then all of them are placed in a bag and for each patient, after obtaining informed consent, a paper is removed randomly and without replacement, and based on the letter written on it, the desired intervention is performed for the patient. In addition, interventions A (case group) or B (control group) are determined by a lot.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and physician are blinded regarding drug or placebo
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Comittee of Tehran University of Medical Science
Street address
Yas Hospital, North Nejatollahi Avenue, karim Khanz and bridge, villa street
City
Tehran
Province
Tehran
Postal code
159781597878
Approval date
2022-02-09, 1400/11/20
Ethics committee reference number
IRCT. TUMS. MEDICINE. REC. 1400.1332
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97.8
ICD-10 code description
Female infertility of other origin
Primary outcomes
1
Description
Positive BhCG 14 days after IUI
Timepoint
14 days after IUI
Method of measurement
BhCGmu/dl
Secondary outcomes
1
Description
Chemical pregnancy
Timepoint
Two weeks after IUI
Method of measurement
BhCG levels
Intervention groups
1
Description
Intervention group: Tablet 250mg/day one month before IUI cycle willbe used by patients
Category
Treatment - Drugs
2
Description
Control group: Tablet placebo onece daily one month before IUI cycle willbe used
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yas hospital
Full name of responsible person
Fatemeh Davari Tanha
Street address
Yas hospital, North nejatollahi avenue, Karimkhan handbridge, Villa street
City
Tehran
Province
Tehran
Postal code
159781597878
Phone
+98 21 8880 0115
Email
Fatedavtanha@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mis.Mostofi
Street address
Fifth floor, Central building of Tehran University of Medical sciences, Ghods avenue, Keshavarz boulevard
City
Tehran
Province
Tehran
Postal code
159781597878
Phone
+98 21 8880 0115
Email
Fatedavtanha@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy of research of Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Davari Tanha
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital, North Nejatollahi ave, Karim khan zand Bridge, Villa street
City
Tehran
Province
Tehran
Postal code
159781597878
Phone
159781597878
Email
Fatedavtanha@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Davari Tanha
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
North nejatollahi avenue, Karim khan zand Bridge, Villa street
City
Tehran
Province
Tehran
Postal code
159781597878
Phone
+98 21 8880 0115
Email
Fatedavtanha@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Davari Tanha
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
North nejatollahi avenue, Karim khan zand Bridge, Villa street
City
Tehran
Province
Tehran
Postal code
159781597878
Phone
+98 21 8880 0115
Email
Fatedavtanha@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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