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Investigating the effect of daily intramuscular injection of 50 mg progesterone and 800 mg progesterone suppository on the pregnancy success rate in women with low progesterone levels

Protocol summary

Study aim
Investigating the effect of daily intramuscular injection of 50 mg progesterone and 800 mg progesterone suppository on the pregnancy success rate in women with low progesterone levels
Design
This three-phase clinical trial, with parallel groups, randomized (using the allocation randomization rule) is performed on 218 infertile women.
Settings and conduct
In this interventional study, 218 infertile women are selected by convenience sampling method in Yas Hospital. Then, 109 women will be placed in the intervention group (daily intramuscular injection of 50 mg progesterone and 800 mg progesterone suppository) and 109 women will be placed in the control group (800 mg progesterone suppository) using the random allocation method.
Participants/Inclusion and exclusion criteria
Inclusion criteria include women aged 18 to 38 years, with a three-layered endometrial pattern with sufficient thickness (7 mm) after receiving estrogen, progesterone level less than 9.2 ng/ml on the day of transfer, with at least two three-day frozen embryos of good quality (AA, AB, BB). Exclusion criteria: The presence of underlying diseases such as malignancy, advanced heart failure, cirrhosis, progressive chronic neurological diseases, and uterine disorders such as fibroids, polyps, or hydrosalpinx.
Intervention groups
In the intervention group, from the day of embryo transfer, 50 mg ampoule progesterone (intramuscular injection) is prescribed once a day in addition to 400 mg progesterone suppositories every 12 hours. While in the control group, 400 mg progesterone suppositories every 12 hours are prescribed. Then, 4 weeks after the embryo transfer, the presence of pregnancy is assessed, and in case of pregnancy, the aforementioned drugs are continued until 12 weeks after transfer, otherwise, the drugs are stopped.
Main outcome variables
Live birth is measured once at the end of the study.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150105020558N6
Registration date: 2023-02-28, 1401/12/09
Registration timing: prospective

Last update: 2023-02-28, 1401/12/09
Update count: 0
Registration date
2023-02-28, 1401/12/09
Registrant information
Name
Mahbod Ebrahimi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8882 7794
Email address
maebrahimi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-09, 1402/01/20
Expected recruitment end date
2023-08-22, 1402/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of daily intramuscular injection of 50 mg progesterone and 800 mg progesterone suppository on the pregnancy success rate in women with low progesterone levels
Public title
Investigating the effect of increasing the amount of prescribed progesterone on the pregnancy success rate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with a three-layered endometrial pattern with sufficient thickness (7 mm) after receiving estrogen Progesterone level less than 9.2 ng/ml on the day of transfer With at least two three-day frozen embryos of good quality (AA, AB, BB)
Exclusion criteria:
The presence of underlying diseases such as malignancy, advanced heart failure, cirrhosis, progressive chronic neurological diseases, and uterine disorders such as fibroids, polyps, or hydrosalpinx.
Age
From 18 years old to 38 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 218
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation, there are 109 small envelopes containing letter A and 109 small envelopes in the same shape containing letter B in a bag, and for each patient, one envelope is selected randomly.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical Committee of Tehran University of Medical Sciences
Street address
Ethics committee of Tehran University of Medical Sciences, School of Medicine, Pour Sina Ave., Qods Blvd.
City
Tehran
Province
Tehran
Postal code
1598718311
Approval date
2023-02-12, 1401/11/23
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1401.755

Health conditions studied

1

Description of health condition studied
Female infertility
ICD-10 code
N97
ICD-10 code description
Female infertility

Primary outcomes

1

Description
Live birth
Timepoint
Once, after pregnancy termination
Method of measurement
The number of deliveries that resulted in a live-born neonate.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: From the day of embryo transfer, 50 mg ampoule progesterone (intramuscular injection) is prescribed once a day in addition to 400 mg progesterone suppositories every 12 hours. Then, 4 weeks after the embryo transfer, the presence of pregnancy is assessed, and in case of pregnancy, the aforementioned drugs are continued until 12 weeks after transfer, otherwise, the drugs are stopped.
Category
Treatment - Drugs

2

Description
Control group: From the day of embryo transfer, 400 mg progesterone suppositories every 12 hours are prescribed. Then, 4 weeks after the embryo transfer, the presence of pregnancy is assessed, and in case of pregnancy, the aforementioned drug is continued until 12 weeks after transfer, otherwise, the drugs are stopped.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Yas Hospital
Full name of responsible person
Mahbod Ebrahimi
Street address
Yas Hospital, Ostad Nejatolahi Ave., Karimkhan Blvd.
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 917 172 1788
Email
maeb214@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vice-Dean of Research of Tehran University of Medical Sciences, Dr. Fotouhi
Street address
Vice-Dean of Research, Tehran University of Medical Sciences, Floor 6, Qods St., Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1416634793
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Mahbod Ebrahimi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas Hospital, Ostad Nejatolahi Ave., Karimkhan Blvd.
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 4216 0000
Email
maeb214@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahbod Ebrahimi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas Hospital, Ostad Nejatolahi Ave., Karimkhan Blvd.
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 4216 0000
Email
maeb214@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahbod Ebrahimi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas Hospital, Ostad Nejatolahi Ave., Karimkhan Blvd.
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 4216 0000
Email
maeb214@yahoo.com

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
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentified participants.
When the data will become available and for how long
After the manuscript is published.
To whom data/document is available
No limitations.
Under which criteria data/document could be used
Those who are allowed to request to receive non-identifiable personal data or other documents must have a written proposal (including the type of statistical analysis) and the ethics number. any additional analysis must perform under the corresponding author's supervision.
From where data/document is obtainable
Communicate with the corresponding author via email: maeb214@yahoo.com
What processes are involved for a request to access data/document
Any request must be sent through e-mail and accompanied by a proposal with an ethics code under the supervision of Dr. Ebrahimi.
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