The effect of Nigella Sativa on endometrial preparation in frozen embryo transfer cycles
Design
A randomized, single blinded clinical trial with control and parallel groups and 116 participants
Settings and conduct
This single-blind clinical trial will be performed on 116 pregnant women referring to Milad Fertility Clinic in Mashhad who have a frozen fetus and are candidates for embryo transfer. These patients are randomly divided into two groups using computer-generated table of random numbers. In this single-blind study, participants are not aware of the type of grouping and the received treatments.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women between 20 and 42 years old with a frozen fetus who are candidate for embryo transfer; Exclusion criteria: Allergy to herbal medicines and specifically Nigella Sativa
Intervention groups
Intervention group: In this group, patients are prescribed one Nigella Sativa capsule each night in the first 7 days of menstruation and then one in the morning and one at night until the endometrium is ready; Control group: In this group, patients are prescribed estradiol 2mg tablets with a dose of 4 mg in the first 7 days of menstruation and then with a dose 6 mg until the endometrium is ready
Main outcome variables
Endometrial thickness, fertility rate, implantation, clinical and subclinical pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170315033085N5
Registration date:2021-03-23, 1400/01/03
Registration timing:prospective
Last update:2021-03-23, 1400/01/03
Update count:0
Registration date
2021-03-23, 1400/01/03
Registrant information
Name
malihe afiat
Name of organization / entity
Mashhad medical school
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2608
Email address
afiatm@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-09, 1400/01/20
Expected recruitment end date
2021-09-19, 1400/06/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Nigella Sativa capsules in order to prepare endometrium for frozen embryo transfer
Public title
Effect of Nigella Sativa capsules on preparation of endometrium for frozen embryo transfer cycles
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women between 20 and 42 years old with a frozen fetus who are candidate for embryo transfer
Exclusion criteria:
Allergy to herbal medicines and specifically Nigella Sativa
Age
From 20 years old to 42 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
116
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with table of random numbers available at ''www.randomization.com'' website will be used. Numbers will be placed in sealed envelopes and each envelope is assigned to one participant placing them in one of the two groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is a single blinded clinical trial. Based on the random codes generated, participants are assigned to one of these two groups. Participants are not aware of the type of grouping and received treatment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2020-10-18, 1399/07/27
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.599
Health conditions studied
1
Description of health condition studied
Decreased or lack of fertility in a woman of childbearing age
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
Endometrial thickness
Timepoint
Third, tenth, twelfth, and fourteenth day of the cycle
Method of measurement
Transvaginal ultrasound
2
Description
Fertility rate
Timepoint
Two weeks after embryo transfer
Method of measurement
Beta HCG test
3
Description
Implantation rate
Timepoint
35 days after embryo transfer and 7 days after a positive result on pregnancy test
Method of measurement
Transvaginal ultrasound
4
Description
Subclinical pregnancy
Timepoint
14 days after embryo transfer
Method of measurement
Beta HCG test
5
Description
Clinical pregnancy
Timepoint
42 days after embryo transfer
Method of measurement
Transvaginal ultrasound
Secondary outcomes
1
Description
live birth rate
Timepoint
after delivery
Method of measurement
live fetus delivery after 28 weeks of gestational age
Intervention groups
1
Description
Intervention group: In this group, patients are prescribed one Nigella Sativa capsule each night in the first 7 days of menstruation and then one in the morning and one at night until the endometrium is ready.
Category
Treatment - Drugs
2
Description
Control group: In this group, patients are prescribed estradiol 2mg tablets with a dose of 4 mg in the first 7 days of menstruation and then with a dose 6 mg until the endometrium is ready.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Milad Fertility Clinic
Full name of responsible person
Dr. Malihe Afiat
Street address
Milad Fertility Clinic, East Razi Street, Mashhad, Razavi Khorasan Province
City
Mashhad
Province
Razavi Khorasan
Postal code
9135913556
Phone
+98 51 3853 4021
Email
afiatm@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Malihe Afiat
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Reza Hospital, next to Imam Reza square, Ibne Sina street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2406
Email
afiatm@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Malihe Afiat
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Reza Hospital, next to Imam Reza square, Ibne Sina street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2406
Email
afiatm@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Malihe Afiat
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Reza Hospital, next to Imam Reza square, Ibne Sina street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2406
Email
afiatm@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data can be shared after patients are made unidentifiable.
When the data will become available and for how long
Data can be accessible 6 months after results are published.
To whom data/document is available
Data can be accessible through an email to the corresponding author.
Under which criteria data/document could be used
Data will be available for researchers in universities and other scientific institutes.
From where data/document is obtainable
After sending a request email to the corresponding author, data will be sent in 1 month.
What processes are involved for a request to access data/document