Protocol summary

Study aim
Comparison of IVF outcomes in two conventional protocols (antagonist) and Stop GnRH agonist/GnRH antagonist in PCO patients
Design
The clinical trial has a control group, with parallel groups, without blinding, randomized, on 60 patients. The random allocation method was a block using WWW.Sealedenvelop.com. The blocks will be 2 alleles of size 6.
Settings and conduct
Valiasr Hospital Patients are entered into two groups with two different ovulation stimulation regimens and oocyte puncture is performed
Participants/Inclusion and exclusion criteria
Age 20 to 35 years; PCO criteria based on Rotterdam criteria; Sperm analysis is normal or has the minimum necessary criteria for ICSI; AMH above 5; At least one year of infertility
Intervention groups
In the GnRH regimen, Stop starts in the mid-luteal phase (previous cycle) and stops with the onset of menstruation. Then the gonadotropin cycle starts on days 2-3. In both groups, after 5 days, subcutaneous antagonist injection is performed for two days. But in the usual antagonist regimen, gonadotropins start on days 2-3 of the menstrual cycle with a dose of 150-225 units subcutaneously. The patient takes gonadotropin for at least 5 days, and from the 6th day of gonadotropin use, in both vaginal ultrasound groups, folliculography is performed every 2 or 3 days. When the leading follicle reaches the size of 13-14 mm, the antagonist is started. From now on, in both regimes, when at least 2-3 follicles above 18 are observed, the final trigger is done with GnRH agonist, and 34-40 hours later, the puncture is done.
Main outcome variables
The number of follicles above 16 mm, the degree of SYNCHRONY of follicles, the number and quality of oocytes, the number and quality of embryos

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180409039247N8
Registration date: 2023-08-17, 1402/05/26
Registration timing: prospective

Last update: 2023-08-17, 1402/05/26
Update count: 0
Registration date
2023-08-17, 1402/05/26
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
2023-08-23, 1402/06/01
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial comparing IVF results in two GnRH antagonist protocols and Stop protocol (GnRH agonist/antagonist) in patients with polycystic ovary syndrome
Public title
comparing IVF results in two GnRH antagonist protocols and Stop protocol (GnRH agonist/antagonist) in patients with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
PCO patients according to Rotterdam criteria Age 20 to 35 years Infertility > 1 year Sperm analysis is normal or has the minimum necessary criteria for ICSI AMH above 5
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, history of repeated miscarriage and repeated implantation failure Pharmaceutical reaction to ovulation stimulation drugs Lack of follicle growth suitable for puncture The patient's lack of consent to complete the treatment course Severe Oligoastenoteratospermia
Age
From 20 years old to 35 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
Participants will be randomly assigned to one of two groups. A computerized randomization list, generated by an independent statistician blinded to the trial, will use 1:1 allocation. The block random allocation method was designed by an epidemiologist using WWW.Sealedenvelop.com. The blocks will be 2 alleles of size 6. AAABBB-AABBAB-ABBBAA-AABABB-….., in this sequence A and B that only the main researcher knows its meaning.
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 university of Medical sciences
Street address
East Bagherkhan Street
City
Tehran
Province
Tehran
Postal code
14146
Approval date
2023-07-19, 1402/04/28
Ethics committee reference number
IR.TUMS.IKHC.REC.1402.169

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 follicle synchrony, the number and quality of obtained oocytes (metaphase 1, 2 and GV)
Timepoint
The examination will be cross-sectional on the day of oocyte puncture.
Method of measurement
Questionnaire for demographic information and patient records, ultrasound to check follicles and embryology laboratory information to check the number and quality of oocytes and embryos.

Secondary outcomes

1

Description
Number and quality of embryos
Timepoint
On the day of ovarian puncture
Method of measurement
It is determined by the embryologist three days after the puncture.

Intervention groups

1

Description
Intervention group: In the GnRH group, Stop starts in the mid-luteal phase (previous cycle) and with the onset of menstruation on the 2nd-3rd day of the gonadotropin cycle, the dose of 150-225 units subcutaneously, depending on the patient's condition. The patient takes gonads for at least 5 days, and from the 6th day of taking gonadotropin, vaginal ultrasound and follicography are performed every 2 or 3 days. When the leading follicle reaches the size of 13-14 mm, the antagonist is started, and when at least 2-3 follicles above 18 are observed, the final trigger is done with GNRH agonist, and 34-40 hours later, the puncture is done.
Category
Treatment - Drugs

2

Description
Control group: In this group, gonadotropins are started on day 2-3 of the menstrual cycle with a dose of 150-225 units subcutaneously, depending on the patient's condition. The patient takes gonads for at least 5 days, and from the 6th day of taking gonadotropin, vaginal ultrasound and follicography are performed every 2 or 3 days. When the leading follicle reaches the size of 13-14 mm, the antagonist is started, and when at least 2-3 follicles above 18 are observed, the final trigger is performed with GNRH agonist, and 34-40 hours later, the puncture is performed.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Vali-e-Asr hospital
Full name of responsible person
Marjan Ghaemi
Street address
East Bagherkhan Street
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6116 2365
Email
marjan_ghaemi@yahoo.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 Steet. 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 Ghaemi
Position
Assissted professor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam khomeini hospital
City
Tehran
Province
Tehran
Postal code
14146
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 Ghaemi
Position
Assissted professor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam khomeini hospital
City
Tehran
Province
Tehran
Postal code
14146
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 Ghaemi
Position
Assissted professor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Emam khomeini hospital
City
Tehran
Province
Tehran
Postal code
14146
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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