Comparison of the efficacy of repeated gonadotropin-releasing hormone agonist (GnRH-a) versus adding low dose human chorionic gonadotropin (HCG) for ovulation induction in patients with polycystic ovary syndrome undergoing IVF/ICSI
Assessment of the efficacy of repeated gonadotropin-releasing hormone agonist (GnRH-a) versus adding low dose human chorionic gonadotropin (HCG) for ovulation induction in patients with polycystic ovary syndrome undergoing IVF/ICSI
Design
This study is designed as a randomized, phase 3 clinical trial with parallel groups, and a sample size of 60 participants. The randomization method will be the block randomization method.
Settings and conduct
This RCT will be conducted at Arash women's Hospital on women with infertility and PCOS. Eligible patients will be divided into two groups after obtaining informed consent. A transvaginal ultrasound will be performed on the second or third day of the menstrual cycle. Ovulation induction will be performed using the rFSH drug at a dose of 150-225 units. After 5 days, if the dominant follicle size is more than 12 mm, 0.25 mg GnRH antagonist will be injected every day. Follicle growth will be monitored by vaginal ultrasound. triggering will be performed if there are at least three dominant follicles (>=17 mm). Type of triggering depends on whether the patient is in group A or B. Both groups will undergo oocyte pick up 34 to 36 hr later.
Due to the patient's knowledge of the type of intervention performed, it is not possible to blind the patient.
Participants/Inclusion and exclusion criteria
Infertile women with PCOS who are aged 18-38 years old and have normal BMI, normal uterine cavity will be included. History of repeated implantation failure, Endocrinopathies, intaking OCP, and use of TESE or PESA are the exclusion criteria.
Intervention groups
Group A: Subcutaneous injection of 0.2mg Decapeptyl ampoule (GnRH-a) that will be repeated with a half-dose after 12 hr
Group B: Subcutaneous injection of 0.2 mg Decapeptyl ampoule (GnRH-a) with 2000 units of HCG ampoule
Main outcome variables
Rate of OHSS, number of oocytes, M II oocytes, and embryos
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110731007165N8
Registration date:2019-12-19, 1398/09/28
Registration timing:prospective
Last update:2019-12-19, 1398/09/28
Update count:0
Registration date
2019-12-19, 1398/09/28
Registrant information
Name
Ladan Kashani
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8828 1866
Email address
kashani_ladan@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-31, 1398/10/10
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of repeated gonadotropin-releasing hormone agonist (GnRH-a) versus adding low dose human chorionic gonadotropin (HCG) for ovulation induction in patients with polycystic ovary syndrome undergoing IVF/ICSI
Public title
repeated gonadotropin-releasing hormone agonist (GnRH-a) versus low dose human chorionic gonadotropin (HCG)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged between 18-38 years old
Body mass index below 30 and above 19 kg/m2
Normal uterine cavity
Ovulation induction by GnRH antagonist cycle regimen
Exclusion criteria:
Repeated implantation failure
WHO 1 group
Using Percutaneous Epididymal Sperm Aspiration (PESA) or testicular sperm extraction (TESE)
History of taking oral contraceptive pills for more than three months before the IVF
Endocrinopathies
Age
From 18 years old to 38 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The statistician will divide eligible participants into two groups by using block randomization method. The size of the blocks in this study will be six. The randomization tool used in this study is sealed envelopes that will be prepared by the statistician.
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, Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2019-09-02, 1398/06/11
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1398.493
Health conditions studied
1
Description of health condition studied
Infertility associated with polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Ovarian hyperstimulation syndrome (OHSS)
Timepoint
At the end of the study
Method of measurement
Hospital records
2
Description
Metaphase II (MII) oocytes
Timepoint
At the end of the study
Method of measurement
Hospital records
3
Description
Total Number of oocytes
Timepoint
At the end of the study
Method of measurement
Hospital records
4
Description
Number of embryos
Timepoint
At the end of the study
Method of measurement
Hospital records
Secondary outcomes
1
Description
Endometrial thickness
Timepoint
At the time of embryo transfer
Method of measurement
Vaginal Ultrasound
2
Description
Embryos quality
Timepoint
At the end of the study
Method of measurement
Hospital records
Intervention groups
1
Description
First Intervention group (Group A): Subcutaneous injection of 0.2mg Decapeptyl ampoule (GnRH-a) that will be repeated with a half-dose after 12 hr
Category
Treatment - Drugs
2
Description
Second Intervention group (Group B): Subcutaneous injection of 0.2 mg Decapeptyl ampoule (GnRH-a) with 2000 units of HCG ampoule
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash women's hospital
Full name of responsible person
Dr.Ladan Kashani
Street address
No. 162 َAlley (Abdul Majid), Shahid Baghdarnia Street (North Rashid), Shahid Bagheri Highway, Resalat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3283
Fax
+98 21 7788 3196
Email
Kashani_ladan@tums.ac.ir
Web page address
http://arash.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Ali Sahraian
Street address
Qods St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3619
Fax
+98 21 8163 3611
Email
rmo@tums.ac.ir
Web page address
http://vcr.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
Arash Women 's Hospital
Full name of responsible person
Dr. Mahdiyeh Sadat Portabatabaei
Position
Obstetrics and Gynecology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 162 َAlley (Abdul Majid), Shahid Baghdarnia Street (North Rashid), Shahid Bagheri Highway, Resalat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7771 9922
Fax
+98 21 7788 3196
Email
prtbtbaeim@gmail.com
Web page address
http://arash.tums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ladan Kashani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 162 َAlley (Abdul Majid), Shahid Baghdarnia Street (North Rashid), Shahid Bagheri Highway, Resalat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3195
Fax
Email
Kashani_ladan@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ladan Kashani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 162 َAlley (Abdul Majid), Shahid Baghdarnia Street (North Rashid), Shahid Bagheri Highway, Resalat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3195
Fax
Email
Kashani_ladan@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available