General aim: to investigate the results of ovarian stimulation with the DuoStim protocol on patients with poor ovarian response and compare the results in the luteal and proliferative phase.
Design
In this study, there is only one intervention group and there is no control group. Each patient is subjected to gonadotropin stimulation in both ovarian phases (proliferative and luteal) and the results of both phases are compared.
Clinical trial without control group, without randomization on 26 patients
Settings and conduct
26 infertile poor ovarian response patients referred to the infertility center of Shahid Beheshti Hospital in Isfahan
The patients are subjected to ovarian induction in two proliferative and luteal phases with the DuoStim protocol. Blinding was not done in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women who are known as patients with poor response to ovulation stimulation according to diagnostic criteria.
Exclusion criteria: Azoospermia / history of uterine surgery / severe endometriosis/ hydrosalpinx/ endocrine disorders / history of repeated abortions/repeated failure of implantation more than or equal to 3 times
Intervention groups
In the DuoStim method, ovarian stimulation is performed in both ovarian phases in all patients with poor ovarian response. In this study, there is only one intervention group and no control group.
Main outcome variables
Overall fertility percentage, the average number of oocytes and the average number of metaphase 2 oocytes after ovulation, the average number of embryos obtained after in vitro fertilization and the average quality of embryos obtained in the proliferative phase and luteal phase.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221001056068N1
Registration date:2022-11-22, 1401/09/01
Registration timing:registered_while_recruiting
Last update:2022-11-22, 1401/09/01
Update count:0
Registration date
2022-11-22, 1401/09/01
Registrant information
Name
Safa Salehi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 919 455 9022
Email address
mina.salehi123321@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-02, 1401/07/10
Expected recruitment end date
2022-12-31, 1401/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of ovarian stimulation in proliferative and luteal phases in an ovarian cycle (DuoStim method) in patients with poor ovarian response
Public title
Comparing the effects of ovarian stimulation in infertile patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: Women who are known as patients with poor response to ovulation stimulation according to POSEIDON 3 and 4 diagnostic criteria and will undergo the necessary treatment protocols for IVF/ICSI.
Exclusion criteria:
Azoospermia confirmed via a semen analysis
History of surgery on the uterus
Severe endometriosis through history and ultrasound findings
Hydrosalpinx by ultrasound or hysterosalpingography
Endocrine disorders such as diabetes, thyroid through blood biochemistry test
Body Mass Index (BMI)>30
History of hysteroscopy
History of recurrent abortions in the history
History of recurrent failure of implantation (more than or equal to 3 times )
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
26
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Research Ethics Committee of the "Alzahra Research Centers"
Street address
Hezar jarib Street
City
Esfahan
Province
Isfehan
Postal code
۷۳۴۶۱۸۱۷۴۶
Approval date
2022-09-11, 1401/06/20
Ethics committee reference number
IR.ARI.MUI.REC.1401.183
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
The overall percentage of fertility in the proliferative phase and the luteal phase
Timepoint
Day 14 and day 28 after the start of ovarian stimulation
Method of measurement
optical microscope
Secondary outcomes
1
Description
The average number of metaphase 2 oocytes after ovulation in the proliferative phase and the luteal phase
Timepoint
Day 14 and day 28 after the start of ovarian stimulation
Method of measurement
optical microscope
2
Description
The average number of oocytes after ovulation in proliferative phase and luteal phase
Timepoint
Day 14 and day 28 after the start of ovarian stimulation
Method of measurement
optical microscope
3
Description
The average of number of 3-day-old embryos obtained after in vitro fertilization in the proliferative phase and the luteal phase
Timepoint
Day 17and day 31after the start of ovarian stimulation
Method of measurement
optical microscope
4
Description
The average quality of 3-day-old embryos obtained in proliferative phase and luteal phase
Timepoint
Day 17and day 31after the start of ovarian stimulation
Method of measurement
optical microscope
Intervention groups
1
Description
Intervention group: In the DuoStim method, ovarian stimulation is performed in both ovarian phases. From the third day of menstruation, all poor ovarian response patients who are candidates for in vitro fertilization undergo ovulation stimulation with gonadotropin at a dose of 300 units daily with Karma brand human gonadotropin (HMG) 150 units and Sinnal brand recombinant follicle stimulation hormone (FSH) 150 units. When the follicle diameter is higher than 14 mm, gonadotropin releasing hormone (GnRH) antagonist with Steronax brand 0.25 is used daily, and when at least two follicles with a diameter of 17 mm are seen through vaginal ultrasound with volusonE6 brand ultrasound machine, Ovitrol is used to trigger the oocyte of the patients. 250 single doses are used. Before transferring to the operating room for ovulation, polymerase chain reaction (PCR) test for COVID19 is requested from the couple, and if the corona test is negative, ovulation is performed. (Proliferative phase) On the same day, a sperm sample is taken from the wife and prepared by a laboratory process and microinjection is performed by an embryologist. Then, 3 days after ovulation, vaginal ultrasound is performed again to see the follicle, and the same drugs as mentioned (HMG and recombinant FSH and then GnRH antagonist) are started and continue with Ovitrol until the trigger time. Then ovulation is done (luteal phase) and on the same day, a sperm sample is taken from the wife and prepared by a laboratory process and microinjection is done by an embryologist.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Shahid Beheshti Hospital
Full name of responsible person
Safa Salehi
Street address
Metal Bridge - Ostad Motahari Street - Obstetrics and Gynecology Hospital - Shahid Beheshti Isfahan
City
Esfahan
Province
Isfehan
Postal code
5354181848
Phone
+98 31 3236 7001
Email
mina.salehi123321@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asghari
Street address
Research and Technology Vice-Chancellor, Building No. 4, Isfahan University of Medical Sciences and Health Care Services, Hazar Jarib St.
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3060
Email
askari@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Safa Salehi
Position
Non-faculty specialist doctor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 2, Reyhan 6 Alley, Motahari St.
City
Bushehr
Province
Boushehr
Postal code
7517836363
Phone
009877333535655
Email
mina.salehi123321@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Safa Salehi
Position
Non-faculty specialist doctor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 2, Reyhan 6 Alley, Motahari St.
City
Bushehr
Province
Boushehr
Postal code
7517836363
Phone
009877333535655
Email
mina.salehi123321@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Safa Salehi
Position
Non-faculty specialist doctor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 2, Reyhan 6 Alley, Motahari St.
City
Bushehr
Province
Boushehr
Postal code
7517836363
Phone
009877333535655
Email
mina.salehi123321@gmail.com
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
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
-
When the data will become available and for how long
-
To whom data/document is available
-
Under which criteria data/document could be used
-
From where data/document is obtainable
-
What processes are involved for a request to access data/document