The Comparison of the GnRH Agonist-Antagonist Protocol (AAP) with GnRH Antagonist Protocol in Women with Poor Ovarian Response in Assisted Reproduction Technique (ART) during Controlled Ovarian Hyper Stimulation Cycles
The Comparison of the GnRH Agonist-Antagonist Protocol (AAP) with GnRH Antagonist Protocol in Women with Poor Ovarian Response in Assisted Reproduction Technique (ART) during Controlled Ovarian Hyper Stimulation Cycles
Design
In this double-blinded randomized controlled clinical trial, 80 infertile female patients will be randomly divided into two groups of 40 cases.
Settings and conduct
This study will be performed in infertility department of Zeinab Educational Center of Shiraz. The intervention group receive gonadotropin (225 units of gonadal F and 3 HMG ampoules) on the second day of menstruation, and each time the follicle reaches a size of 13-14 mm, the GnRH antagonist (Cetrotide, 0.25 mg SQ) is injected and continued with gonadotropins until the follicle reaches a size of 17-18 mm and finally artificial insemination will take place. In the control group, after gonadotropin and HMG injection, treatment with GnRH antagonist was continued without gonadotropins. Patients and clinical researchers will not be informed about the distribution of the drugs between two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients aged between 18 and 42 years who fulfill the Bologna criteria; lack of endometriosis stage 3 and 4; and no specimen of TESE (Testicular Sperm Extraction).
Exclusion criteria: Presence of the specimen of TESE (Testicular Sperm Extraction); endometriosis stage 3 and 4.
Intervention groups
Infertile women candidates for using the assisted reproduction technique (ART) will be randomly divided into two groups of intervention and control:
1- Intervention group: Eligible infertile women (according to Bologna criteria) who are treated with GnRH agonist-antagonist protocol.
2- Control group: Eligible infertile women (according to Bologna criteria) who are treated with GnRH antagonist protocol.
Main outcome variables
Successful implantation rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120708010210N9
Registration date:2020-04-10, 1399/01/22
Registration timing:registered_while_recruiting
Last update:2020-04-10, 1399/01/22
Update count:0
Registration date
2020-04-10, 1399/01/22
Registrant information
Name
Afsun Zarei
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1233 2365
Email address
zareia@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-14, 1398/01/25
Expected recruitment end date
2020-05-20, 1399/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of the GnRH Agonist-Antagonist Protocol (AAP) with GnRH Antagonist Protocol in Women with Poor Ovarian Response in Assisted Reproduction Technique (ART) during Controlled Ovarian Hyper Stimulation Cycles
Public title
The Comparison of Two Protocols for Treatment of Infertility
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 42 years
All patients fulfill the Bologna criteria
Exclusion criteria:
Presence of the specimen of TESE (Testicular Sperm Extraction)
Endometriosis stage 3 and 4
Age
From 18 years old to 42 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is performed using the block method and Random Allocation Software version 2 will be used in the preparation of 4-case blocks. The drugs in both groups are packaged and numbered in similar vials apparently by a researcher who is not involved in patient selection and follow-up.
Blinding (investigator's opinion)
Double blinded
Blinding description
The clinical investigators (in direct contact with the patient), and participants will not be aware of the distribution of the drugs in the groups (double blinded), so that they are unaware of the content and dosage of the prescribed medication, and the medications will be similar in appearance.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Faculty of medicine, Zand Avenue
City
Shiraz
Province
Fars
Postal code
71937-11351
Approval date
2019-12-15, 1398/09/24
Ethics committee reference number
IR.SUMS.MED.REC.1398.516
Health conditions studied
1
Description of health condition studied
Female infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Clinical pregnancy rate
Timepoint
Two months after embryo transfer
Method of measurement
Vaginal sonography
2
Description
Chemical pregnancy rate
Timepoint
Fourteen days after embryo transfer
Method of measurement
Pregnancy Test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: GnRH antagonist (Cetrotide, 0.25 mg SQ) with gonadotropin (225 units of gonadal F and 3 HMG ampoules) until artificial insemination
Category
Treatment - Drugs
2
Description
Control group: GnRH antagonist (Cetrotide, 0.25 mg SQ) and continuing treatment without gonadotropin until artificial insemination
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrate Zeinab Hospital
Full name of responsible person
Parisa Keshtkaran
Street address
Sibooyeh blvd
City
Shiraz
Province
Fars
Postal code
71538-13311
Phone
+98 71 3726 6811
Email
zeinabhp@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Younes Ghasemi
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand Ave.
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3235 7282
Fax
+98 71 3235 7282
Email
ghasemiy@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Parisa Keshtkaran
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hazrat Zeinab Hospital, Sibuyeh blvd.
City
Shiraz
Province
Fars
Postal code
71538-13311
Phone
+98 71 3726 6812
Fax
+98 71 3726 6812
Email
parisa_18_k@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Afsoon Zarei
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hazrat Zeinab Hospital, Sibuyeh blvd.
City
Shiraz
Province
Fars
Postal code
71538-13311
Phone
+98 71 3726 6812
Fax
+98 71 3726 6812
Email
zareia@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Parisa Kestkaran
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hazrat Zeinab Hospital, Sibuyeh blvd.
City
Shiraz
Province
Fars
Postal code
71538-13311
Phone
+98 71 3726 6812
Fax
+98 71 3726 6812
Email
parisa_18_k@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
Information about main outcomes of the study
When the data will become available and for how long
Six months after publishing the results
To whom data/document is available
Researchers in universities and scientific and research centers
Under which criteria data/document could be used
In order to improve the treatment of infertility and subsequent researches and with the permission of the authors
From where data/document is obtainable
Department of Obstetrics and Gynecology of Shiraz university of medical sciences
What processes are involved for a request to access data/document
Sending the request in writing or by email to the authors