Investigating the effect of repeated doses compared to the single dose of Decapeptil on improving oocyte maturation and fertility rate in women with polycystic ovary syndrome in assisted reproductive cycles
Investigating the effect of repeated doses of GnRH agonist (decapeptyl) on improving egg maturation and fertility rate in women with polycystic ovary syndrome in assisted reproductive cycles.
Design
Clinical trial with a control group, with parallel groups, triple blinded, randomized, phase 3 on 60 patients. In this study, a simple tap or line randomization method was used.
Settings and conduct
The place of the study is the infertility center of Shahid Beheshti Hospital in Isfahan, which will be conducted on 60 patients. For blinding, the clinical caregiver will deliver the drug labeled by the researcher based on the grouping of the patients, and the patient will inject the drug at the requested time. The researcher will provide the results of the tests based on group A and B to the analyst. In this way, the patient, clinical caregiver and analyst are kept blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria : women with polycystic ovary syndrome; Stimulation with GnRH antagonist protocol; Age 20-38 years; Estradiol concentration > 2500 international units on the trigger day; body mass index > 18 and < 30; Having an indication for assisted reproductive methods; Willingness to participate in the study
Exclusion criteria: severe factor of male infertility; uterine anomalies; severe endometriosis; metabolic disease (for example, metabolic syndrome); Age over 38 and under 20 years; Patients with hypogonadism, hypogonadotropism
Intervention groups
Intervention group (A): two doses of decapeptyl 12 hours apart.
Control group (B): a single dose of decapeptyl
Main outcome variables
The number of mature oocyts; The number of retrieved oocyts; The number of blastocysts
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180708040381N5
Registration date:2024-05-12, 1403/02/23
Registration timing:prospective
Last update:2024-05-12, 1403/02/23
Update count:0
Registration date
2024-05-12, 1403/02/23
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
2024-06-04, 1403/03/15
Expected recruitment end date
2024-09-05, 1403/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of repeated doses compared to the single dose of Decapeptil on improving oocyte maturation and fertility rate in women with polycystic ovary syndrome in assisted reproductive cycles
Public title
The Effect of Repeated Dose of Decapeptile on Fertility Rate in PCOS
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)
Patients with hypogonadism, hypogonadotropism
Patients with underlying diseases such as thyroid disease, 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
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 will be used, and each client will be placed in the intervention or control group by tossing a coin, tap and line.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The study participants will be divided into groups A and B after randomization. For blinding, the clinical caregiver will deliver the drug labeled by the researcher based on the grouping of the patients, and the patient will inject the drug at the requested time. The researcher will provide the results of the tests based on group A and B to the analyst. In this way, the patient, clinical caregiver and analyst are blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Faculty of Medicine, Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences; Hazar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2024-01-27, 1402/11/07
Ethics committee reference number
IR.MUI.MED.REC.1402.407
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
Number of mature oocyte
Timepoint
34-36 hours after decapeptil injection
Method of measurement
Transvaginal ultrasound
2
Description
Number of retrieved oocytes
Timepoint
34-36 hours after decapeptil injection
Method of measurement
Transvaginal 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: Group A: a subcutaneous injection dose of GnRH agonist (decapeptil) 0.2 mg (made by Ronac company) and then a second dose of decapeptil 0.1 mg injected 12 hours after the first dose
Category
Treatment - Drugs
2
Description
Control group: Group B: single subcutaneous injection dose of GnRH agonist (decapeptil) 0.2 mg (mADE by Ronac company)
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 Beheshti Hospital; Shahid Motahari Street
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
Isfahan University of Medical Sciences; Hazar Jarib Street
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
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
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
Shahid Beheshti Hospital; Motahari Street
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
Shahid Beheshti Hospital; Motahari Street
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
Shahid Beheshti Hospital; Motahari Street
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)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Confidentiality of information of people participating in the study
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
When the data will become available and for how long
To whom data/document is available
Under which criteria data/document could be used
From where data/document is obtainable
What processes are involved for a request to access data/document