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Protocol summary
This study will be conducted as a clinical trial. The studied sample will be selected from among the patients referred to Ibn Sina Infertility Treatment Center for IUI and egg donation who have the necessary criteria to enter the study, 18 people will be selected in each IUI, IVF group.
This study will be conducted as a clinical trial. The studied sample will be selected from among the patients referred to Ibn Sina Infertility Treatment Center for IUI and egg donation who have the necessary criteria to enter the study, 18 people will be selected in each IUI, IVF group. The intervention will start with the injection of progesterone at a dose of 20 mg (the main recommended dose) as an ovulation trigger. The intermediate analysis will be done after the evaluation of the 9th volunteer, and if Lh surge fails in more than 5 people, sampling will be stopped.
This study will be conducted as a clinical trial. The studied sample will be selected from among the patients referred to Ibn Sina Infertility Treatment Center for IUI and egg donation who have the necessary criteria to enter the study, 18 people will be selected in each IUI, IVF group. The intervention will start with the injection of progesterone at a dose of 20 mg (the main recommended dose) as an ovulation trigger. The intermediate analysis will be done after the evaluation of the 9th volunteer, and if Lh surge fails in more than 5 people, sampling will be stopped.
این مطالعه به صورت کارآزمایی بالینی انجام خواهد شد. نمونه مورد بررسی از بین بیماران مراجعه کننده به مرکز درمان ناباروری ابن سینا جهت IUI و اهدای تخمک که دارای معیارهای لازم برای ورود به مطالعه باشند به تعداد 18 نفر در هر گروه IUI,IVF انتخاب خواهند شد.
این مطالعه به صورت کارآزمایی بالینی انجام خواهد شد. نمونه مورد بررسی از بین بیماران مراجعه کننده به مرکز درمان ناباروری ابن سینا جهت IUI و اهدای تخمک که دارای معیارهای لازم برای ورود به مطالعه باشند به تعداد 18 نفر در هر گروه IUI ,IVF انتخاب خواهند شد. مداخله با تزریق پروژسترون با دوز 20 میلی گرم (دوز اصلی پیشنهادی) به عنوان تریگر تخمک گذاری آغاز خواهد شد. آنالیز میانی پس از ارزیابی 9 امین داوطلب انجام خواهد شد و در صورت شکست Lh surge در بیش از 5 نفر نمونه گیری متوقف می شود.
این مطالعه به صورت کارآزمایی بالینی انجام خواهد شد. نمونه مورد بررسی از بین بیماران مراجعه کننده به مرکز درمان ناباروری ابن سینا جهت IUI و اهدای تخمک که دارای معیارهای لازم برای ورود به مطالعه باشند به تعداد 18 نفر در هر گروه IUI,IVFIUI ,IVF انتخاب خواهند شد. مداخله با تزریق پروژسترون با دوز 20 میلی گرم (دوز اصلی پیشنهادی) به عنوان تریگر تخمک گذاری آغاز خواهد شد. آنالیز میانی پس از ارزیابی 9 امین داوطلب انجام خواهد شد و در صورت شکست Lh surge در بیش از 5 نفر نمونه گیری متوقف می شود.
Protocol summary
Study aim
Determining the effect of progesterone as a trigger of ovulation gonadotropins
- Determining the effect of progesterone as an ovulation trigger in IVF/IUI cycles
Design
Clinical trial with parallel groups, without blinding, phase 3 on 36 patients, in two groups of IUI and IVF
Settings and conduct
This study will be conducted as a clinical trial. The studied sample will be selected from among the patients referred to Ibn Sina Infertility Treatment Center for IUI and egg donation who have the necessary criteria to enter the study, 18 people will be selected in each IUI, IVF group. The intervention will start with the injection of progesterone at a dose of 20 mg (the main recommended dose) as an ovulation trigger. The intermediate analysis will be done after the evaluation of the 9th volunteer, and if Lh surge fails in more than 5 people, sampling will be stopped.
Participants/Inclusion and exclusion criteria
1. Patient age 20-35 years
2. Normal hysterosalpingography in IUI group patients
3. normal vaginal ultrasound
4. Thyroid, prolactin, sugar and normal CBC tests
5. AMH above 2 ng/ml
6. Absence of diagnosed genetic or autoimmune disease
Intervention groups
Patients referred for IUI and egg donation who have the necessary criteria to enter the study will be placed in two groups, IU and IVF.
Main outcome variables
Primary Outcome Study of LH Surge Occurrence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240506061667N1
Registration date:2024-05-18, 1403/02/29
Registration timing:prospective
Last update:2024-05-25, 1403/03/05
Update count:1
Registration date
2024-05-18, 1403/02/29
Registrant information
Name
Manizheh Fathalian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2230 3909
Email address
mahtab.fathi358@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-04, 1403/03/15
Expected recruitment end date
2024-08-05, 1403/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The role of progesterone as an ovulation trigger in IVF and IUI cycles, a clinical trial
Public title
The role of progesterone in ovulation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Patient age 20-35 years 2. Hysterosalpingography is normal in IUI group patients 3. Vaginal ultrasound is normal 4. Thyroid, prolactin, sugar and CBC tests are normal 5. AMH above 2 6. Genetic or autoimmune disease has been diagnosed
Exclusion criteria:
1. egg donation clients whose IVF cycle is canceled due to lack of suitable follicles (10-15) 2. history of ovarian cyst and endometriosis 3. patient unwillingness 4. immune and rheumatic disease 5. sensitivity to progesterone
Age
From 20 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
N/A
Randomization description
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
Research Institute of New Technologies of Biological Sciences of Ibn Sina Academic Jihad
Street address
No. 97, Yakhchal St., Shariati St
City
Tehran
Province
Tehran
Postal code
1941913114
Approval date
2024-04-23, 1403/02/04
Ethics committee reference number
IR.ACECR.AVICENNA.REC.1403.003
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation
Primary outcomes
1
Description
Primary Outcome Study of LH Surge Occurrence
Timepoint
It is at 12 and 36 hours after injection
Method of measurement
In the ultrasound before the intervention, as well as the serum level of FSH, progesterone and estrogen at 12 and 36 hours after the injection.
Secondary outcomes
1
Description
The secondary outcome is the total number of eggs obtained
Timepoint
It is at 12 and 36 hours after injection
Method of measurement
In the ultrasound before the intervention, as well as the serum level of FSH, progesterone and estrogen at 12 and 36 hours after the injection.
Intervention groups
1
Description
Intervention group A: 18 people will be selected in the IVF group among the patients referred to Ibn Sina infertility treatment center for egg donation who have the necessary criteria to enter the study. In this study, egg donation patients undergo IVF cycle with antagonist protocol. The intervention will start with the injection of progesterone with a dose of 20 mg as an ovulation trigger
Category
Treatment - Drugs
2
Description
Intervention group B: Intervention group: 18 people in each IUI group will be selected from the patients referred to Ibn Sina Infertility Treatment Center for IUI who have the necessary criteria to enter the study. In this study, in IUI patients, GNRH antagonist is started when the follicle is 14 mm. The intervention will start with the injection of progesterone with a dose of 20 mg as an ovulation trigger.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ibn Sina Infertility Treatment Center
Full name of responsible person
Simin Zafardoost
Street address
No. 97, Yakhchal St., Shariati St
City
Tehran
Province
Tehran
Postal code
1941913114
Phone
+98 21 23519
Email
siminzafardoost@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
r.ghahremanzadeh@avicenna.ac.ir
Street address
No., Yakhchal St., Shariati St
City
Tehran
Province
Tehran
Postal code
1941913114
Phone
+98 21 23519
Email
r.ghahremanzadeh@avicenna.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranian academic center for education culture and research
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Simin Zafardoost
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No., Yakhchal St., Shariati St
City
Tehran
Province
Tehran
Postal code
1941913114
Phone
+98 21 23519
Email
siminzafardoost@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Simin Zafardoost
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 97, Yakhchal St., Shariati St
City
Tehran
Province
Tehran
Postal code
1941913114
Phone
+98 21 23519
Email
siminzafardoost@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Mohaddese Aghaeinajad
Position
Non-faculty specialist doctor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 97, Yakhchal St., Shariati St
City
Tehran
Province
Tehran
Postal code
1941913114
Phone
+98 21 23519
Email
mahtab.fathi358@gmail.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
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data related to non-identifiable personal information of individuals will be accessible if needed
When the data will become available and for how long
Immediately after the publication of the article, if necessary, non-identifiable data will be provided
To whom data/document is available
The data will be available to all researchers in scientific and academic centers
Under which criteria data/document could be used
De-identified patient data will be available upon request by researchers
From where data/document is obtainable
The e-mail of the project managers is available to request information and data of the project
What processes are involved for a request to access data/document
The request is sent through the e-mail of the organizers of the project