A comparison between effect of two kinds of triggering with GnRh agonist in PCO patients treated by antagonist protocol for ART on oocyte and embryo quality
comparison of oocyte maturity rate between two kinds of triggering with GnRh agonist
Design
Two arm parallel group randomized trial
Settings and conduct
This study is done on 110 patients who need ART treatment and refer to infertility center of Yazd. Since the second day of cycle the patients receive 150 unit of cinal f(cinagen-Iran) Subcutaneously. When the follicles reach to 12-13 mm, cetrotide (Merck- Serono Germany)250 micro gram are injected daily subcutaneously. when at least 3 follicles reach to 17 mm, serum level of LH, E2 and progesterone are checked (Monobind _USA kit).The patients who have serum estradiol level more than 3000 pg/ml are divided to two groups by random numbers.
The intervention group are triggered with decapeptyl 0.2 mg(Ferring_Germany) at 9 pm, after 12 hours,LH serum level is checked again, and the second dose of decapeptyl 0.1 mg is injected subcutaneously.12 Hours later LH serum level is checked again.
The control group are triggered by decapeptyl 0.1 mg at 9 pm.12 and 24 hours later LH serum level is checked. Oocyte retrieval is done in both group 36 hours after first injection of decapeptyl. Fertilization is done.The embryos with good quality are freezed.They are transferred to uterus in another cycles.
Participants/Inclusion and exclusion criteria
1-Pco patients who need ART treatment.
2-Age of patients should be 20 to 38 years.
2-They shouldn't have sever endometriosis, sever male factor disease,uterine anomaly and metabolic disease.
Intervention groups
The cases are triggered by two dose of GnRh a.At first decapeptyl 0.2 milligram(Ferring_Germany) and after 12 hours the second dose of decapeptyl 0.1 milligram are injected.The patients who are control group are triggered by one dose of decapeptyl 0.2 milligram.
A comparison between effect of two kinds of triggering with GnRh agonist in PCO patients treated by antagonist protocol for ART on oocyte and embryo quality
Public title
effect of two kinds of triggering with GnRh agonist in antagonist protocol
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pco patients who need ART treatment.
They have serum estradiol level more than 3000 pg/ml in triggering day.
Their age should be 20 to 38 years.
Exclusion criteria:
Sever endometriosis
Sever male factor infertility
uterine anomaly
Metabolic disease
Age
From 20 years old to 38 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
At first we choose 110 patients who include the condition,and we give them 1 to 110 number, based on their referring. The patients are divided to two 55 persons groups by using random allocation soft ware and random codes.When patients refer to clinic, based on their number, they are settled in the specific 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 Shahid Sadoughi University of Medical Science
Street address
Bou_Ali Ave
City
Yazd
Province
Yazd
Postal code
8916877391
Approval date
2018-12-02, 1397/09/11
Ethics committee reference number
IR.SSU.RSI.1397.022
Health conditions studied
1
Description of health condition studied
Triggering with different doses of GnRh a in PCO patients
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
Mature oocyte (M2) count
Timepoint
After oocyte retrieval
Method of measurement
Counting mature oocyte under microscopy
Secondary outcomes
1
Description
Embryos quality and embryo count
Timepoint
48 hours after fertilization
Method of measurement
Assessment under microscopy by embryologist.
Intervention groups
1
Description
Intervention group: The intervention group are triggered by subcutaneous injection of decapeptyl (Triptorelin) 0.2 mg, after 12 hours the second doses ofdecapeptyl 0.1 mg are injected (two dose GnRh a).
Category
Treatment - Drugs
2
Description
Control group: The control group are triggered by subcutaneous injection of decapeptyl 0.2 mg (one dose GnRh a).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Research and clinical center for infertility, Bou-Ali Ave, Sfaeyeh, Yazd, Iran
Full name of responsible person
Abbas Aflatoonian
Street address
Bou-Ali Ave, Safaeyeh, Research and clinical center for infertility
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
abbas_aflatoonian@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
ِDR.Mohammad Reza Mirjallili
Street address
Bahonar Ave
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3725 8770
Email
Info@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Masrooreh Hoseini
Position
Infertility Fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bou-Ali, Safaeyeh, Research and clinical center for infertility
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
masroorehoseini@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Abbas Aflatoonian
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bou_Ali, Safaeyeh, Research and clinical center for infertility
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
abbas_aflatoonian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masrooreh Hoseni
Position
Infertility Fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bou_Ali Ave, Safaeyeh, Research and clinical center for infertility
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
masroorehoseini@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to the privacy of patients
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
The study protocol, the statistical analysis map, the clinical study report will be available after the publishing of the article .
When the data will become available and for how long
After publishing the article
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
use in the retrospective study
From where data/document is obtainable
Yazd research and clinical center for infertility
What processes are involved for a request to access data/document
Request from the Research Deputy, submitted to the Research Council of the Center if the request accepts its referral to the security and after completion of the relevant forms, the request is referred to the research experts and then get the data.