Clinical Trial Protocol
Iranian Registry of Clinical Trials
05 Nov 2022
Comparison of novel Delayed start antagonist protocol vs Flare up
agonist protocol on IVF outcome in poor response patients according to Bologna criteria
Protocol summary
Summary
This randomized single blind clinical trial is designed to compare the novel delayed start antagonist protocol vs.
flare up agonist protocol on IVF outcome in poor response patients. Inclusion criteria: poor response patients according to Bologna criteria; age between 18-44 years old; BMI: 18-30; access to motile sperm;
without any clomifene citrate treatment from 1 month ago; normal menstruation cycles; normal serum prolactin; normal uterine cavity in histrosalpingography.
Exclusion criteria: age older than 44 years and Less than 18 years old; history of the hypothalamus or pituitary tumor; history of endocrine diseases such as diabetes, thyroid disorders or adrenal diseases; endometriosis Grade 3 and 4. The sample size based on previous studies was considered 40. After selecting patients, history and demographic data is collected. Complete physical examination by a gynecologist along with ultrasound and routine tests and surveys is performed and two stimulation protocol is applied randomly to the patients. After final maturation, oocyte are harvested in operation room. The granuolsal cells are separated for evaluation of expression of genes involved in the development of follicles and oocyte. Mature oocytes are injected and all resulting embryos will be transferred after 3-5 days. Eventually the number of oocytes obtained, oocyte quality, embryo number and quality, cycle cancellation rate, fertilization rate, rate of gene expression involved in the development of follicles and oocyte, number of embryo transfer, number of
biochemical pregnancy and levels of E2, LH and FSH on the day of hCG injection will be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number: IRCT2016091722903N2 Registration date: 2016-10-03, 1395/07/12 Registration timing: registered_while_recruiting
Last update:
Update count: 0 Registration date
2016-10-03, 1395/07/12 Registrant information
Name
Shirzad Hoseini
Name of organization / entity
Tehran University of Medical Sciences Country
Iran (Islamic Republic of) Phone
+98 917 113 3440 Email address
sh-hoseini@razi.tums.ac.ir Recruitment status
Recruitment complete Funding source
Vice Chancellor for Research, Tehran University of Medical Sciences
Expected recruitment start date 2016-10-01, 1395/07/10
Expected recruitment end date 2017-10-02, 1396/07/10 Actual recruitment start date
empty
Actual recruitment end date empty
Trial completion date empty
Scientific title
Comparison of novel Delayed start antagonist protocol vs Flare up agonist protocol on IVF outcome in poor
response patients according to Bologna criteria Public title
Comparison of novel antagonist protocol vs agonist protocol on IVF outcome in poor response patients Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: poor response patients according to Bologna criteria; age between 18-44 years old; BMI:
18-30; access to motile sperm; without any clomifene citrate treatment from 1 month ago; normal
menstruation cycles; normal serum prolactin; normal uterine cavity in histrosalpingography. Exclusion criteria:
age older than 44 years and Less than 18 years old;
history of the hypothalamus or pituitary tumor; history of endocrine diseases such as diabetes, thyroid disorders or adrenal diseases; endometriosis Grade 3 and 4.
Age
From 18 years old to 44 years old Gender
Female Phase
N/A
Groups that have been masked No information
Sample size
Target sample size: 40
Randomization (investigator's opinion) Randomized
Randomization description Blinding (investigator's opinion)
Single 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 Scienes
Street address
Department of Anatomy, Medical School, Tehran University of Medical Sciences, Ghods Street, Enghelab e Islami Street, Tehran, Iran.
City Tehran Postal code Approval date
2016-08-21, 1395/05/31
Ethics committee reference number IR.TUMS.VCR.REC.1395.481
Health conditions studied
1
Description of health condition studied Infertility
ICD-10 code N97
ICD-10 code description Female infertility
Primary outcomes
1
Description Number of oocyte Timepoint
After intervention Method of measurement
Microscope
2
Description Oocyte quality Timepoint
After intervention Method of measurement
Microscope
3
Description
Number of embryo Timepoint
After intervention Method of measurement
Microscope
4
Description Embryo quality Timepoint
After intervention Method of measurement
Microscope
5
Description
Number of cancelled cycles Timepoint
After intervention Method of measurement
Patient file
6
Description
Number of fertilized oocyte Timepoint
After intervention Method of measurement
Microscope
7
Description
expression rate of genes involved in the development of oocyte
Timepoint
After intervention Method of measurement
Real Time PCR
8
Description
Stimulation duration Timepoint
After intervention Method of measurement
Patient file
Secondary outcomes
1
Description
Number of embryo transfer Timepoint
After intervention Method of measurement
Patient file
2
Description
Number of pregnancy Timepoint
After intervention Method of measurement
B-HCG Test
3
Description E2 levels Timepoint
Before and after intervention Method of measurement
ELIZA Test
4
Description LH Levels Timepoint
Before and after intervention
Method of measurement ELIZA Test
5
Description FSH Levels Timepoint
Before and after intervention Method of measurement
ELIZA Test
Intervention groups
1
Description
Control (Agonist) Group: Basal day 3 hormonal evaluation for FSH, LH, and E2 was done in a natural cycle. Patients will receive a low dose oral contraceptive pill started on cycle day 1 of the previous cycle for 21 days. Three days after the end of the pill, Triptorelin (0.025 mg/day) and a fixed-dose r-FSH (450 IU/l) is administered until the day of hCG injection. Final oocyte maturation was triggered with 10,000 IU hCG when the largest two follicles attained a mean diameter of 18 mm with a general cohort of follicles >13 mm. Patients were allowed to proceed to oocyte retrieval if three or more follicles were in the dominant range (<13 mm in diameter). Ovum pickup (OPU) was done after 36 hours of HCG and metaphase II oocytes were analyzed. The granuolsal cells are separated for evaluation of expression of genes involved in the development of follicles and oocyte. Mature oocyte is injected and all resulting embryos will be transferred after 3-5 days.
Category
Treatment - Drugs
2
Description
Intervention (Antagonist) Group: Basal day 3 hormonal evaluation for FSH, LH, and E2 was done in a natural cycle. Ovarian stimulation is started after 7 days of GnRH antagonist pretreatment (0.25 mg ganirelix acetate), with 300 IU FSH and 150 IU hMG. GnRH antagonist (0.25 mg ganirelix acetate; Organon) was added to prevent premature ovulation when the lead follicle measured
<12 mm and was continued until the hCG trigger. Final oocyte maturation was triggered with 10,000 IU hCG when the largest two follicles attained a mean diameter of 18 mm with a general cohort of follicles >13 mm.
Patients were allowed to proceed to oocyte retrieval if three or more follicles were in the dominant range (<13 mm in diameter). Ovum pickup (OPU) was done after 36 hours of HCG and metaphase II oocytes were analyzed.
The granuolsal cells are separated for evaluation of expression of genes involved in the development of follicles and oocyte. Mature oocyte is injected and all resulting embryos will be transferred after 3-5 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Mother and Child Ghadir hospital Full name of responsible person Street address
City Shiraz
Sponsors / Funding sources
1 Sponsor
Name of organization / entity
Vice Chancellor for Research of Tehran University of Medical Sciences
Full name of responsible person Masud Yunesian
Street address
Vice Chancellor for research, Tehran University of Medical Sciences, Ghods Street, Enghelab e Islami Street, Tehran, Iran.
City Tehran Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Tehran University of Medical Sciences
Proportion provided by this source 100
Public or private sector empty
Domestic or foreign origin empty
Category of foreign source of funding empty
Country of origin
Type of organization providing the funding empty
Person responsible for general inquiries
Contact
Name of organization / entity Shiraz University of Medical Sciences Full name of responsible person
Mohammad Ebrahim Parsanezhad Position
Gynecologist/ Chairman of Department of Obstetrics and Gynecology
Other areas of specialty/work Street address
Department of Obstetrics & Gynecology, Medical School, Shiraz University of Medical Sciences, Zand
street, Shiraz, Iran City
Shiraz Postal code Phone
+98 71 3212 5419 Fax
parsame@sums.ac.irparsanezhad@msn.com Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of medical Scienses Full name of responsible person
Aligholi Sobhani Position
Ph.D in Anatomy
Other areas of specialty/work Street address
Department of Anatomy, Medical School, Tehran University of Medical Sciences, Ghods Street, Enghelab e Islami Street, Tehran, Iran City
Tehran Postal code Phone
+98 21 6641 9072 Fax
sobhania@.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
Shirzad Hoseini Position
Ph.D in Reproductive Biology Other areas of specialty/work Street address
No. 42, Second deadlock, Shahid Kobar 1 Alley, Maali Abad Bridge, Shiraz, Iran
City Shiraz Postal code Phone
+98 71 3623 8942 Fax
Shirzad.hoseini@gmail.com Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
empty Study Protocol
empty
Statistical Analysis Plan empty
Informed Consent Form empty
Clinical Study Report empty
Analytic Code empty Data Dictionary
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