comparing double dose and triple dose of GNRH agonists in Endometriosis triggering undergoing ART cycle.
Design
80 patients with definite diagnosis of endometriosis 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 T who receive triple dose.
Settings and conduct
All procedures are performed by a surgeon in a private referral endometriosis hospital (Dena Hospital - Shiraz - Iran).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 recombinant FSH and GNRH antagonist. evaluation of follicles will be monitored by vaginal ultrasound. once the follicles have reached the required size, 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 recieve double dose and the other one will recieve triple dose of GNRH agonists.
Participants/Inclusion and exclusion criteria
Women with a definite diagnosis of endometriosis ,21-35 years
Intervention groups
80 patients with endometriosis under assisted reproductive therapy, after performing the necessary tests and diagnostic ultrasound that meet the inclusion criteria will be randomly divided into two groups of D and T. after stimulating the follicles, we will trigger the group D with double dose and group T with triple dose of GNRH agonists.
Main outcome variables
At the end of the study, 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:IRCT20200925048836N2
Registration date:2022-01-21, 1400/11/01
Registration timing:prospective
Last update:2022-01-21, 1400/11/01
Update count:0
Registration date
2022-01-21, 1400/11/01
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
2022-02-18, 1400/11/29
Expected recruitment end date
2022-06-20, 1401/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing double dose and tirple dose of GNRH agonists in Endometriosis triggering undergoing ART cycle
Public title
The effect of different amounts 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 ART method,
normal serum FSH concentration in primary follicular phase
, AMH>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 HCG
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
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 (T), 5 (T),……. 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 T or Ddrug.
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 T 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
2021-06-12, 1400/03/22
Ethics committee reference number
IR.SUMS.MED.REC.1400.160
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
ICD-10 code description
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, 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 triptorelin (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, 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 triptorelin (GNRH agonist). After 12 hours The same drug will be repeated at a dose of 0.1 mg.12 hours later, triptorelin 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
Recruitment centers
1
Recruitment center
Name of recruitment center
Dena hospital fertility clinic
Full name of responsible person
Goudarzi Zahra
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
Abbas Rezaianzadeh
Street address
Shiraz University of Medical Sciences, Zand St, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ ۷۱۳۴۸
Phone
+98 71 3230 5410
Email
rezaiana@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
Askari Elham
Position
Assistant Professor
Latest degree
Medical doctor
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
Fax
+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
Askari Elham
Position
Assistant Professor
Latest degree
Medical doctor
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
Fax
+98 71 3233 2365
Email
elliaskary_md@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Askari Elham
Position
Assistant Professor
Latest degree
Medical doctor
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
Fax
+98 71 3233 2365
Email
elliaskary_md@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
I have not decided yet - the release schedule is still unknown