Protocol summary

Study aim
Comparision of corifollitropin alfa versus recombinant FSH in poor ovarian responders
Design
Clinical trial with a control group, with parallel groups, randomized, phase 3 on 90 patients. The rand function of Excel software was used for randomization.
Settings and conduct
This study is conducted as an RCT in 1401-1403 in the IVF department of Taleghani Hospital, Infertility Department. Patients with previous poor response in ivf cycles are assigned to two groups receiving corifollitropin alfa and recombinant FSH, which are assigned to one of the two treatment methods based on the randomization method with permutation blocks. will be divided
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with poor ovarian response in at least one previous ivf cycle, less than 40 years old, who had at least two of the following criteria: AFCL<5, AMH<1.2ng/dl, less than 3 oocytes in the previous cycle Study exclusion criteria: uterine anomalies, history of untreated endocrine problems, heart, lung and liver problems and severe and uncontrolled underlying disease, unilateral or bilateral hydrosalpinx, prohibition of gonadotropin use, egg donors, severe male infertility (azoospermia, oligoasthenoteratospermia), stage 4 endometriosis, BMI <18 or >30 More about this source textSource text required for additional translation information Send feedback Side panels
Intervention groups
patients with poor ovarian response in at least one previous ivf cycle, less than 40 years old, who had at least two of the following criteria: AFCL<5, AMH<1.2ng/dl, less than 3 oocytes in the previous cycle
Main outcome variables
the number of oocytes obtained, the number of embryoblasts and the number of blastocytes obtained, the fertilization rate, implantation rate, and pregnancy rate.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221016056198N1
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
Nazanin Hajizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2600
Email address
hajizadeh.nazanin94@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-19, 1401/07/27
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision of corifollitropin alfa versus recombinant FSH in poor ovarian responders
Public title
evaluation the effect of Alnavar drug on patients with low ovarian reserve in ivf cycle
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with hystory of previous cycle ; that who fulfilled at least two of the following criteria were admitted: Antral follicle count (AFC) < 5;Antimullerian hormone (AMH) < 1,1 ng/ml;Less than three oocytes obtained in the previous cycle;
Exclusion criteria:
uterine abnormalities, recent or current history of any current untreated endocrine abnormality, unilateral or bilateral hydrosalpinx contraindications for the use of gonadotropins
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with previous poor response in ivf cycles will be divided into two groups receiving corifollitropin alpha and recombinant FSH, which will be assigned to one of the two treatment methods based on randomization with replacement blocks with random EXCEL software. All patients will be informed about the study method and cost before entering the study. The advantages and disadvantages of the performed treatment will be informed and an informed consent form will be obtained.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In reproduction and infertility, poor response to ovarian stimulation is one of the important problems and challenges of Bronchis, which causes additional costs, multiple cycles, discouragement and hopelessness in patients, and despite the use of different treatment regimens to manage this special group of patients, there is no single protocol. Corivolitropin alfa (CFA) is a long-acting gonadotropin designed as a stable follicular stimulator with the ability to simplify ovarian stimulation, given that one subcutaneous injection can replace the first seven injections of each cycle. follicle stimulating hormone (FSH). This is especially important considering the psychological discomfort and despair and the high rate of abandonment of continuing IVF treatment in these patients.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committe of Shahid Beheshti University of Medical Sciences
Street address
Velenjak.shahid arabi street
City
Tehran
Province
Tehran
Postal code
1985717413
Approval date
2022-11-13, 1401/08/22
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.520

Health conditions studied

1

Description of health condition studied
diminished ovarian reserve in IVF cycle
ICD-10 code
N97.8
ICD-10 code description
Female infertility of other origin

Primary outcomes

1

Description
The rate of continuous pregnancy is defined despite the intrauterine gestational sac with a fetal pole that shows cardiac activity during the 9th to 10th week of pregnancy.
Timepoint
9-10week after embryo transfer
Method of measurement
trans vaginal sonography

2

Description
Clinical pregnancy rate, which is defined as the presence of an intrauterine gestational sac in the 7th week of pregnancy
Timepoint
7week after embryo transfer
Method of measurement
trans vaginal sonography

Secondary outcomes

1

Description
Implantation rate per number of transferred embryos
Timepoint
3-5 weeks after embryo transfer
Method of measurement
trans vaginal sonography

Intervention groups

1

Description
Intervention group that recieved corifolitropin alfa(Elonva),100 microgeram,start at 2th day of mense,Behestan daroo factory
Category
Treatment - Drugs

2

Description
Control group that recieved recombinant FSH,follitropin alfa,cinnal f,150 mg,cinnagen drug factory
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani Infertility Clinic
Full name of responsible person
Nazanin Hajizadeh
Street address
Velenjak Street
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2600
Email
Hajizadeh.nazanin94@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nasrin Saharkhiz
Street address
Velenjak
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2600
Fax
+98 21 2243 2570
Email
saharkhiz1377@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
10
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nazanin Hajizadeh
Position
Assistant fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Velenjak
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2600
Email
hajizadeh.nazanin94@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nazanin Hajizadeh
Position
Assistant infertility fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Velenjak
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2246 3400
Email
hajizadeh.nazanin94@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nazanin Hajizadeh
Position
Assistant Fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Velenjak
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2246 3400
Email
hajizadeh.nazanin94@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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