Protocol summary

Study aim
Comparison of ivf outcomes in two regimens of ovulation stimulation, conventional (antagonist) and Stop GnRH-agonist/GnRH-antagonist in poor ovarian responses
Design
A clinical trial with a control group, with parallel groups, double-blind, non-randomized on 60 patients
Settings and conduct
In antagonist protocol, from the 2nd-3rd day of the mens, Clomiphene started, one tablet every 12 hours, and Elnova, which is a long-acting gonadotropin, is taken at a dose of 150 and from the 6th day of gonadotropin, While in the stop protocol, the gnrh agonist starts in the mid-luteal phase (previous cycle) and stops with the onset of menstruation and after confirmation of ovarian inhibition in TVS. Then, from the 2nd-3rd day of the clomiphene cycle, one pill every 12 hours is started, and he takes an ampoule of Elnova with a dose of 150. In both groups, after 5 days, ultrasound was performed when the leading follicle reached 13-14 mm in size, the antagonist was started and when at least 2-3 follicles above 18 that the final trigger is done and opu is done 34-40 hours later.
Participants/Inclusion and exclusion criteria
POR patients (age (≤40 years) or any other risk factor for POR such as endometriosis and ovarian surgery, autoimmune diseases and genetic problems 2: previous presence of ≤3 eggs with the usual stimulation protocol 3: abnormality of ovarian reserve tests
Intervention groups
Use of the new Stop GnRH-agonist/GnRH-antagonist ovulation stimulation protocol in patients with poor response compared to the usual antagonist regimen
Main outcome variables
primary outcomes of the number of follicles above 16 mm, follicle synchrony, number and quality of oocytes and the secondary outcomes of the number and quality of embryos - total dose of gonadotropins - and final cost

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180409039247N10
Registration date: 2024-06-15, 1403/03/26
Registration timing: prospective

Last update: 2024-06-15, 1403/03/26
Update count: 0
Registration date
2024-06-15, 1403/03/26
Registrant information
Name
Marjan Ghaemibidgoli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8800 4858
Email address
m_ghaemi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2024-10-22, 1403/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of IVF outcomes in two GnRH-antagonist and Stop GnRH-agonist/GnRH-antagonist protocols in patients with poor ovarian response
Public title
Comparison of IVF outcomes in two GnRH-antagonist and Stop GnRH-agonist/GnRH-antagonist protocols in patients with poor ovarian response
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
POR patients according to the Bologna criteria: old age (40 years) or any other risk factor for POR such as endometriosis and ovarian surgery, autoimmune diseases and genetic problems Achieving ≤3 oocytes with the gnrh antagonist stimulation protocol in the previous cycle Abnormality of ovarian reserve tests (AFC<3-5, AMH<0.5-1.1 ng) in the absence of old age of the mother or abnormality of ovarian reserve BMI below 27 Sperm analysis is normal or has the minimum necessary criteria for ICSI
Exclusion criteria:
History of autoimmune diseases, coagulation disorders, uterine anomalies, chromosomal and genetic disorders, chronic renal and metabolic diseases, hypo and hyperthyroidism, history of malignancy, endometriosis recurent pregnancy loss recurrent implantation failure
Age
From 40 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
A computerized randomisation list, generated by an independent statistician blinded to the trial and unrelated to the subjects involved, will use 1:1 allocation. All participants are blinded to the list. The block random allocation method was designed by an epidemiologist using WWW.Sealedenvelop.com. The blocks will be 2 alleles of size 6.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran Universitu of Medical Sciences
Street address
East Bagherkhan Street, Imam Complex Hospital
City
Tehran
Province
Tehran
Postal code
1414635181
Approval date
2024-03-10, 1402/12/20
Ethics committee reference number
IR.TUMS.IKHC.REC.1402.525

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 number of follicles above 16 mm, the degree of SYNCHRONY of the follicles, the number and quality of the obtained oocytes (metaphase 1 and 2 and GV)
Timepoint
The time to evaluate the results will be on the same day of oocyte retrieval.
Method of measurement
Evaluations are performed in IVF lab and recorded by an embryologist.

Secondary outcomes

1

Description
the number and quality of embryos obtained - the total dose of gonadotropins used - and the final cost of treatment
Timepoint
The time to evaluate the results will be on the same day of oocyte puncture
Method of measurement
Evaluation is done by an embryologist

Intervention groups

1

Description
Intervention group: stop GnRH-ag/GnRH-ant protocol
Category
Treatment - Drugs

2

Description
Control group: Conventional gnrh antagonist protocol
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Vali-e-Asr hospital
Full name of responsible person
Azadeh Tarafdari
Street address
East Bagherkhan
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6116 2365
Email
azadehmehr@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Quds St. intersection with Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8163 0000
Email
info@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Marjan Ghaemibidgoli
Position
Infertility fellowship
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam khomeini hospital
City
Tehran
Province
Tehran
Postal code
1414635181
Phone
+98 21 8800 4858
Fax
Email
marjan_ghaemi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Marjan Ghaemibidgoli
Position
Infertility fellowship
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam khomeini hospital
City
Tehran
Province
Tehran
Postal code
1414635181
Phone
+98 21 8800 4858
Fax
Email
marjan_ghaemi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Marjan Ghaemibidgoli
Position
Infertility Fellowship
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam khomeini hospital
City
Tehran
Province
Tehran
Postal code
1414635181
Phone
+98 21 8800 4858
Fax
Email
marjan_ghaemi@yahoo.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
Undecided - It is not yet known if there will be 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
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