Comparative investigation of pregnancy outcomes by ovulation stimulation with GnRH agonist with and without adding HCG in women with polycystic ovarian syndrome in IVF cycles.
Determining and comparing the results of pregnancy by stimulating ovulation with GnRH agonist with and without adding HCG in women with polycystic ovary syndrome in IVF cycles.
Design
A clinical trial with a control group with parallel groups, three blinded, randomized, phase 3 on 60 patients and the method of randomization by a colleague informed by the study.
Settings and conduct
A double-blind randomized prospective interventional study - Hazrat Maryam Infertility Center, Shahid Beheshti Hospital, Isfahan, - The patient, the researcher, and the analyzers were blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
1) Selection of women with PCOS based on ESHRE ASRM Rotterdam criteria
2) Stimulation with GnRH antagonist protocol
3) Age 20-38 years
4) E2 concentration > 2500 international units on the trigger day
5) Body mass index > 18 and < 30
6) Having an indication for IVF or ICSI
7) Willingness to participate in the study
Exclusion criteria:
1) Severe cause of male infertility
2) Uterine anomalies
3) Severe endometriosis
4) metabolic disease (e.g. metabolic syndrome)
5) Age above 38 and below 20 years
6) Patients with hypogonadism, hypogonadotropism
7) Patients with underlying diseases such as thyroid, hyperprolactinemia, Cushing's syndrome, ovarian and adrenal tumors, diabetes, etc.
Intervention groups
Group A: Decapeptyl + HCG
Group B: Decapeptyl alone
Main outcome variables
The number of mature oocytes ; The number of retrieved oocytes ; The number of blastocysts
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180708040381N4
Registration date:2024-05-02, 1403/02/13
Registration timing:prospective
Last update:2024-05-02, 1403/02/13
Update count:0
Registration date
2024-05-02, 1403/02/13
Registrant information
Name
Mehdi Izadi Zaman Abadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3272 4538
Email address
mimi_izadi2@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-04, 1403/02/15
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
Comparative investigation of pregnancy outcomes by ovulation stimulation with GnRH agonist with and without adding HCG in women with polycystic ovarian syndrome in IVF cycles.
Public title
Investigating ovulation stimulation with the combination of GnRH agonist and HCG in polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Selection of women with PCOS based on ESHRE ASRM Rotterdam criteria
Stimulation with GnRH antagonist protocol
Age 20-38 years
E2 concentration > 2500 international units on the trigger day
Body mass index > 18 and < 30
Having an indication for IVF or ICSI
Willingness to participate in the study
Exclusion criteria:
severe cause of male infertility
Uterine anomalies
Severe endometriosis
metabolic disease (e.g. metabolic syndrome)
Age above 38 and below 20 years
Patients with hypogonadism, hypogonadotropism
Patients with underlying diseases such as thyroid, hyperprolactinemia, Cushing's syndrome, ovarian and adrenal tumors, diabetes, etc.
Age
From 20 years old to 38 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a simple tap or line randomization method was used, and each client was placed in the intervention or control group by tossing a coin, tap and line. One of the advantages of this type of randomization is that the type of treatment allocated in two groups is completely unpredictable and according to probability theory, it can be guaranteed that in a large number, the sample size of the study was the same in the intervention and control groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
After randomization and division into groups A and B, the participants in the study will be given to the relevant expert who, based on the grouping of the people, will prescribe drugs 1 and 2, prepared by another informed expert, in groups A and B, respectively. will do The prescribers and the patient will be blinded in this way. The analyst will review and analyze the data based on the grouping of the patients and finally provide it to the main researcher. With this method, the patient, clinical caregivers, researcher and analyzer are blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Research Faculty of Medicine - Isfahan University of Medical Sciences
Street address
Hazar Jarib Street - Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2024-04-07, 1403/01/19
Ethics committee reference number
IR.MUI.MED.REC.1403.007
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Number of mature oocytes
Timepoint
34-36 hours after decapeptil injection
Method of measurement
Trans vaginal ultrasound
2
Description
Number of retrieved oocytes
Timepoint
34-36 hours after decapeptil injection
Method of measurement
Trans vaginal ultrasound
3
Description
The number of blastocysts
Timepoint
Two weeks after administration of Decapeptil
Method of measurement
Abdominal ultrasound
Secondary outcomes
1
Description
Positive pregnancy test
Timepoint
4 weeks after IVF
Method of measurement
Beta HCG test
Intervention groups
1
Description
Intervention group: HCG + decapeptyl - in group A, a dose of 1500 units of HCG is prescribed 12 hours after the trigger with (decapeptyl) triptorelin sc.
Category
Treatment - Drugs
2
Description
Control group: Decapeptyl - In group B, only a single dose of 0.2 mg triptorelin sc (Decapeptyl) is given.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Maryam Infertility Center, Shahid Beheshti Hospital, Isfahan
Full name of responsible person
Dr Atena Khayambashi
Street address
Shahid Motahari Street - Shahid Beheshti Hospital
City
Isfahan
Province
Isfehan
Postal code
8184853541
Phone
+98 31 3236 7001
Email
beheshti@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Asgari
Street address
Hazar Jarib Street - Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8134
Email
vcr-office@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
80
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
Esfahan University of Medical Sciences
Full name of responsible person
Dr Atena Khayambashi
Position
Infertility Fellowship Assistant
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Motahari Street - Shahid Beheshti Hospital
City
Isfahan
Province
Isfehan
Postal code
8184853541
Phone
+98 31 3236 7001
Email
atena_khayambashi2@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Atena Khayambashi
Position
Infertility Fellowship Assistant
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Motahari Street - Shahid Beheshti Hospital
City
Isfahan
Province
Isfehan
Postal code
8184853541
Phone
+98 31 3236 7001
Email
atena_khayambashi2@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Atena Khayambashi
Position
Infertility Fellowship Assistant
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Motahari Street - Shahid Beheshti Hospital
City
Isfahan
Province
Isfehan
Postal code
8184853541
Phone
+98 31 3236 7001
Email
atena_khayambashi2@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
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
Questionnaire forms and proposal files and articles are available.
When the data will become available and for how long
Immediately after the publication of the article
To whom data/document is available
public
Under which criteria data/document could be used
Information - use in other articles - speeches and others
From where data/document is obtainable
A person who has been selected as responsible for accountability.
What processes are involved for a request to access data/document