Comparison of progesterone effect in preventing LH surge and quality of oocytes and embryos in IVF cycles with patients undergoing antagonist cycle in Shariati Hospital during 97-98
Evaluation of the effect of progesterone and LH antagonists (steroids) to prevent a sudden premature increase in LH in the ART cycle
Design
In this clinical trial study, 120 infertile women will undergo ART.
Settings and conduct
Patients undergoing IVF in Shariati hospital will be studied in two groups: one will receive the LH antagonist group (control group) and the other group will take progesterone (intervention group). We then examine the effect of these two treatments on the LH surge in IVF cycles, as well as the number of mature follicles, the number of embryos transferred, and the rate of pregnancy between the two groups being compared.
Participants/Inclusion and exclusion criteria
• Study entry criteria:
The age between 18 and 35 years was a normal sperm test, a normal body mass index (18-30 kg / m2), the presence of both ovaries and the opening of the tubes.
Criteria for leaving the study include:
Tubal factor, severe endometriosis, hypothalamic amenorrhea, oligoasthenospermia (abnormal sperm count and shape) and severe uterine anomalies.
Intervention groups
One group receives the LH antagonist and the other group receives progesterone
Main outcome variables
LH surge - quality of oocytes - quality of embryos
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200601047630N1
Registration date:2020-09-18, 1399/06/28
Registration timing:retrospective
Last update:2020-09-18, 1399/06/28
Update count:0
Registration date
2020-09-18, 1399/06/28
Registrant information
Name
Aida Najafian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 1000
Email address
anajafian@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2020-03-10, 1398/12/20
Actual recruitment start date
2018-04-04, 1397/01/15
Actual recruitment end date
2020-03-15, 1398/12/25
Trial completion date
2020-03-15, 1398/12/25
Scientific title
Comparison of progesterone effect in preventing LH surge and quality of oocytes and embryos in IVF cycles with patients undergoing antagonist cycle in Shariati Hospital during 97-98
Public title
The effect of progesterone in preventing LH surge in IVF cycles
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The age between 18 and 35 years ,,
a normal sperm test
a normal body mass index (18-30 kg / m2)
the presence of both ovaries and the opening of the tubes
Exclusion criteria:
Tubal factor
severe endometriosis
hypothalamic amenorrhea
oligoasthenospermia (abnormal sperm count and shape)
severe uterine anomalies
Age
From 18 years old to 35 years old
Gender
Female
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
120
Actual sample size reached:
120
Randomization (investigator's opinion)
Randomized
Randomization description
First, all patients who meet the inclusion criteria are entered into an Excel column, and then using the Rand option in this software, in the opposite column, each patient is randomly assigned the number 1 or 2. No. 1: Intervention group and No. 2: control group
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
Ethics committee of Tehran University of Medical Sciences
Street address
Qods st. TUMS
City
Tehran
Province
Tehran
Postal code
1417653911
Approval date
2020-05-04, 1399/02/15
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.008
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
LH surge
Timepoint
End of pregnancy
Method of measurement
blood tests
2
Description
Quality of oocyte
Timepoint
End of pregnancy
Method of measurement
Blood tests
3
Description
Quality of embryo
Timepoint
End of pregnancy
Method of measurement
Blood tests
Secondary outcomes
1
Description
Clinical pregnancy
Timepoint
Day 25 of cycle
Method of measurement
Blood analysis
Intervention groups
1
Description
Intervention group: On day 2-3 of the gonadotropin cycle, including FSH with or without HMG, with medroxyprogesterone 5 mg daily, two doses are given. Vaginal ultrasounds were performed on days 9 to 10, and if 18 to 20 mm follicles were found, HCG was injected for ovulation. Then, 36 hours later, the puncture was performed. If the follicle was less than 18 mm, the Continuation of gonadotropin is done with an additional dose and medroxyprogesterone and ultrasound on the 12th day, and again if on the ultrasound of the 12th day the follicle was 18 to 20 mm, HCG is injected. If the follicle is less than 18 mm, gonadotropin and medroxyprogesterone are continued and then ultrasound is performed on day 14 and a decision is made accordingly. This process continues until day 25 of the cycle and until the follicle responds to treatment, until the day of HCG injection. And medroxyprogesterone is given and medroxyprogesterone is discontinued on the day of HCG injection.
Category
Treatment - Drugs
2
Description
Control group: In the control group, 2 to 3 cycles of gonadotropin, including FSH with or without HMG, are given on day 3, then one week later, vaginal ultrasound is performed. If the follicle is between 18 and 20 mm, HCG is injected for ovulation and then a puncture for IVF is performed 36 hours later. If the follicle is larger than 14 mm, asteroid (gonadotropin antagonist) is given with gonadotropin, and ultrasound is done again on the 12th day. If the follicle is less than 14 mm, the gonadotropin is continued with a double dose and the ultrasound is repeated on the 12th day. On day 12 ultrasound, if an 18 to 20 mm follicle is found, HCG is injected for ovulation and then a puncture is performed 36 hours later.If a 14 mm follicle is found on the ultrasound on day 12, the steroid is started, along with continued gonadotropin, and on day 14 sonography will be done again. If the follicle was less than 14 mm on day 12, the gonadotropin will be continued with an overdose, and on day 14, an ultrasound will be performed, and a decision will be made based on the sonography on day 14. This process can continue until the 25th day of the cycle, ie until the follicle responds to the drug. And patients are excluded from the study when they have a follicle less than 8 mm at the beginning, in fact, 14 mm follicle is the time of onset of steroid and follicle 18 to 20 mm is the time of onset of HCG and continues until the day of HCG gonadotropin and steroid injection.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Sara Pouri
Street address
Jalal Highway
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
shariatihosp@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Sahraeian
Street address
Qods St.
City
Tehran
Province
Tehran
Postal code
1417653911
Phone
+98 21 8163 4208
Email
irsw-leadinghouse@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
Sara Pouri
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Jalal highway
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
Sarapouri65@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ayda Najafian
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Jalal highway
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
anajafian@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sara Pouri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Jalal highway
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
sarapouri65@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Only a part of the data, such as information about the main consequence or the like, can be shared
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Data will only be available to researchers working at academic and scientific institutions
Under which criteria data/document could be used
For research only
From where data/document is obtainable
the email of Dr. Pouri
What processes are involved for a request to access data/document
Apply via email and specify the purpose of using the data