Comparison of long protocol with ovulation stimulation protocol in frozen embryo transfer cycle in women with polycystic ovarian syndrome: a non-randomized clinical trial
To compare long protocol with ovulation stimulation protocol in frozen embryo transfer cycle in women with polycystic ovarian syndrome
Design
This is a non-randomized clinical trial with control group, phase III, in which eligible patients will be selectively assigned to the intervention and control groups.
Settings and conduct
This study will be performed in the Fatemieh Hospital in Hamadan city on 340 eligible patients. The patients will be selectively assigned to the intervention and control groups. Blinding is not possible in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 45 years
Women with polycystic ovary syndrome
Exclusion criteria:
The first or second time of transfer
Uterine abnormality
Egg donation
Surrogacy
Intervention groups
Intervention group:
The long protocol includes a 30 mg birth control pill (manufactured by Aburihan Pharmaceutical Co.) once a night for 14 nights (if the thickness of the endometrium is thin), then GnRH agonist 5.5 mg (manufactured by Sinafect Pharmaceutical Co.) once a day for a week and Estradiol tablet (manufactured by Aburihan Pharmaceutical Co.) 4 to 6 mg for at least 10 days (in case of thin endometrium and absence of ovarian cysts) and intramuscular injection of progesterone (manufactured by Iran Hormon Pharmaceutical Co.) 50 mg daily for 3 to 5 days then embryo is transferred.
Control group:
Ovulation stimulation protocol including injection of FSH (manufactured by Cinagen Pharmaceutical Co.) 300 mg every 2 to 3 days, then injection of HCG (manufactured by Ronak Daro Pharmaceutical Co.) 5000 units as a single dose and 36 hours later (if at least one follicle reaches more than 18 mm and the thickness of the endometrium is at least 7 mm) and intramuscular injection of progesterone 50 mg daily for 3 to 5 days, then embryo is transferred.
Main outcome variables
Occurrence of pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N434
Registration date:2022-07-09, 1401/04/18
Registration timing:prospective
Last update:2022-07-09, 1401/04/18
Update count:0
Registration date
2022-07-09, 1401/04/18
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-06, 1401/05/15
Expected recruitment end date
2023-09-06, 1402/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of long protocol with ovulation stimulation protocol in frozen embryo transfer cycle in women with polycystic ovarian syndrome: a non-randomized clinical trial
Public title
Comparison of long protocol with ovulation stimulation protocol in frozen embryo transfer cycle in women with polycystic ovarian syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 45 years
Women with polycystic ovary syndrome
The first or second time of transfer
Exclusion criteria:
Uterine abnormality
Egg donation
Surrogacy
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
340
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2022-06-25, 1401/04/04
Ethics committee reference number
IR.UMSHA.REC.1401.326
Health conditions studied
1
Description of health condition studied
Polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Occurrence of pregnancy
Timepoint
12 to 14 days after the completion of intervention
Method of measurement
With pregnancy test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The long protocol includes a 30 mg birth control pill (manufactured by Aburihan Pharmaceutical Co.) once a night for 14 nights (if the thickness of the endometrium is thin), then GnRH agonist 5.5 mg (manufactured by Sinafect Pharmaceutical Co.) once a day for a week and Estradiol tablet (manufactured by Aburihan Pharmaceutical Co.) 4 to 6 mg for at least 10 days (in case of thin endometrium and absence of ovarian cysts) and intramuscular injection of progesterone (manufactured by Iran Hormon Pharmaceutical Co.) 50 mg daily for 3 to 5 days ( If the thickness of the endometrium is at least 7 mm) then embryo is transferred.
Category
Treatment - Drugs
2
Description
Control group: Ovulation stimulation protocol including injection of FSH (manufactured by Cinagen Pharmaceutical Co.) 300 mg every 2 to 3 days, then injection of HCG (manufactured by Ronak Daro Pharmaceutical Co.) 5000 units as a single dose and 36 hours later (if at least one follicle reaches more than 18 mm and the thickness of the endometrium is at least 7 mm) and intramuscular injection of progesterone 50 mg daily for 3 to 5 days, then embryo is transferred.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital in Hamadan city
Full name of responsible person
Dr. Zakieh Yarahmadi
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
zakiyehyarahmadi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Zakieh Yarahmadi
Position
Resident of Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
zakiyehyarahmadi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Mahnaz Yavangi
Position
Gynecologist
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
mahnazyavangi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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