Comparing single dose and double dose of Gonadotropin releasing hormone agonist in endometriosis triggering undergoing Assisted reproductive technology
Design
80 patients with endometriosis under assisted reproductive therapy after selection based on inclusion and exclusion criteria and recording the initial data will be randomly divided into two groups of D who receive double dose and group S who receive single dose.
Settings and conduct
All procedures are performed by a surgeon in a ِDena referral endometriosis hospital. In all patients before oocyte stimulation, the required hormones level will be measured. Primary vaginal ultrasound will be performed. Controlled ovarian stimulation will be performed by recombination Follicle stimulating hormone and Gonadotropin releasing hormone antagonist. Evaluation of follicles will be monitored by vaginal ultrasound. The final stimulation of the follicles will be performed with GNRH agonist drugs Without informing patients. The patients will be randomly divided into two groups. (single blind) one of them will receive double dose and the other one will receive single dose of GNRH agonists.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Definite diagnosis of endometriosis ,21-35 years. Exclusion criteria:History of uterine and ovary surgery,Polycystic ovary syndrome, Triggering with HCG,hypo gonadotrpic hypogonadism
Intervention groups
َAfter performing the necessary tests and diagnostic ultrasound that meet the inclusion criteria will be randomly divided into two groups of D and S. After stimulating the follicles, we will trigger the group D with double dose and group S with single dose of GNRH agonists.
Main outcome variables
Maturation and function of ovums; fertilization and blastocyst conversion; ovarian hyperstimulation syndrome; implantation rate and clinical pregnancy will be determined and compared between the two groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200925048836N3
Registration date:2022-10-21, 1401/07/29
Registration timing:prospective
Last update:2022-10-21, 1401/07/29
Update count:0
Registration date
2022-10-21, 1401/07/29
Registrant information
Name
Elham Askary
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3233 2365
Email address
elliaskary_md@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-06, 1401/08/15
Expected recruitment end date
2023-05-22, 1402/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparing single dose and double dose of Gonadotropin-releasing hormone (GNRH ) agonist in endometriosis triggering undergoing assisted reproductive technology (ART) cyle
Public title
The effect of assisted reproductive drugs in endometriosis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with a definite diagnosis of endometriosis based on pathology report
Aged between 21 and 35 years
The first period of using Assisted reproductive technology (ART) method
Normal serum Follicle stimulating hormone (FSH) concentration in primary follicular phase
Anti mullerian hormone (AMH) more than 0.5, presence of both ovary
Having the ART use indication that they are willing to participate in the study
Exclusion criteria:
History of uterine and ovary surgery
Poly cystic ovarian syndrome
Triggering with Human chorionic gonadotropin (HCG) drug
Severe fertilizing disorder in spouse
Patient with hypo gonadotrpic hypogonadism and uterine abnormality
Age
From 21 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The treatment allocation list is already designed on Block Balanced Randomization Method by software ( https://mahmoodsaghaei.tripod.com/Softwares/randalloc.html) (D), 2 (ِD), 3 (D), 4 (S), 5 (S),……. Any eligible patient will be given a 1 to 80 code after obtaining informed consent in order to visit the clinic and based on above block, they receive S or D drug.
Patients information will be collected through an interview with the patients. Randomization will be performed by an experienced nurse using a random number table. The patient, embryologist, gynecologist and statistician will be unaware of the groupings.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients will receive S or D medication based on randomized block in double blind method and a code will be allocated to each patient (1 to 80) that will be encoded at the end of the study. The patients and the designer and drug distributer are not aware of the drug pack. This study is the second phase of trial .
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
Headquarters Of Shiraz University of Medical Sciences, Zand St
City
Shiraz
Province
Fars
Postal code
34786-71946
Approval date
2022-09-11, 1401/06/20
Ethics committee reference number
IR.SUMS.REC.1401.417
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N80.1
ICD-10 code description
Endometriosis of ovary
Primary outcomes
1
Description
Oocyte maturation
Timepoint
Before and after treatment
Method of measurement
Transvaginal sonography
Secondary outcomes
1
Description
Oocyte yield
Timepoint
Before and after treatment
Method of measurement
Transvaginal sonography and hormonal assay
Intervention groups
1
Description
In intervention group 1 (D), on day 2 or 3 of the menstrual cycle, controlled ovarian stimulation with recombinant FSH (Gonal-f, merck senoro) at a dose of 175-112.5 IU / DAY will be performed for 4 days. FSH dose based on ovarian response and serum estradiol level It will be adjusted when the target follicle is more than 14 mm and the serum concentration of estradiol is more than 300 pg / ml. The antagonist-Ganirelix drug (Orgalutran, Organon) will be used at a subcutaneous dose of 0.25 mg / day. Follicle development will be monitored by transvaginal ultrasound with a 4-8 MHz vaginal probe. When the three follicles reach a diameter greater than 17 mm, the final maturation of the ovum will be performed with a single subcutaneous dose of 0.2 mg diphereline (GNRH agonist). After 12 hours The same drug will be repeated at a dose of 0.1 mg. Ovum pick up under vaginal ultrasound guidance will be performed 35 hours after the first dose under general anesthesia with a single lumen needle (Swemed, Vitrolife).
Category
Treatment - Drugs
2
Description
In intervention group 2 (S), on day 2 or 3 of the menstrual cycle, controlled ovarian stimulation with recombinant FSH (Gonal-f, merck senoro) at a dose of 175-112.5 IU / DAY will be performed for 4 days. FSH dose based on ovarian response and serum estradiol level It will be adjusted when the target follicle is more than 14 mm and the serum concentration of estradiol is more than 300 pg / ml. The antagonist-Ganirelix drug (Orgalutran, Organon) will be used at a subcutaneous dose of 0.25 mg / day. Follicle development will be monitored by transvaginal ultrasound with a 4-8 MHz vaginal probe. When the three follicles reach a diameter greater than 17 mm, the final maturation of the ovum will be performed with a single subcutaneous dose of 0.2 mg diphereline (GNRH agonist). Ovum pick up under vaginal ultrasound guidance will be performed 35 hours after the first dose under general anesthesia with a single lumen needle (Swemed, Vitrolife).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dena hospital fertility clinic
Full name of responsible person
Zahra Goudarzi
Street address
Dena hospital, Zargari blvd
City
Shiraz
Province
Fars
Postal code
71867-64951
Phone
+98 71 3649 0411
Email
info@denahospital.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahtab Memar Pour
Street address
Shiraz University of Medical Sciences, Zand St, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۸۱۴۳۳۶
Phone
+98 71 3230 5410
Email
memarpour@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
Elham Askari
Position
Assitant
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of Obstetrics and Gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
07134814336
Phone
+98 71 3233 2365
Email
elliaskary_md@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Elham Askari
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of Obstetrics and Gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
City
shiraz
Province
Fars
Postal code
71348143360
Phone
+98 71 3233 2365
Email
elliaskary_md@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Elham Askari
Position
Department of Obstetrics and Gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Department of Obstetrics and Gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71348143360
Phone
+98 71 3233 2365
Email
elliaskary_md@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
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
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
Title and more details about the data/document
Statistical Results
When the data will become available and for how long
6 month after the project completion
To whom data/document is available
By obtaining a license from the ethics committee and for scientific and research use in coordination with the main researchers
Under which criteria data/document could be used
The data is for use in this design only. If necessary, after obtaining the necessary permits from the ethics committee
From where data/document is obtainable
To researchers responsible for responding to this plan
What processes are involved for a request to access data/document
Written request Coordinated by the ethics committee 2 months