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Comparing the expression levels of BMP15, GDF9, FLT1 and HIF1 genes in granulosa cells of women with poor ovarian response under GCSF treatment with women with poor ovarian response receiving normal saline: a clinical trial

Protocol summary

Study aim
Comparing the expression levels of BMP15, GDF9, FLT1 and HIF1 genes in granulosa cells of women with poor ovarian response under GCSF treatment with women with poor ovarian response receiving normal saline: a clinical trial
Design
A clinical trial with a control group,with parallel groups,Not blinded,Randomized,Phase 1,2 on 60 patients,The method of random allocation in this study will be the 4-way random permutation block method.
Settings and conduct
Women with poor ovarian response, Hazrat Zainab Shiraz Hospital, Patients in two treatment groups received GCSF and the control group received normal saline after stimulating the ovaries, follicular fluid is collected and the target genes are examined.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Age 20–40 years 2. Poor responder POSEIDON group 3 and 4 3.Ovulation induction by antagonist protocol 4. Normal parameters of semen 5.Having intracytoplasmic sperm injection(ICSI) 6.Willingness to participate in the study and provide written informed consent Non Inclusion criteria 1.Contraindications to ICSI treatment 2.Contraindications to G-CSF and dydrogesterone 3. Inability to fully comply with the study protocol 4. In the past 3 months, G-CSF has been used for treatment 5. Ovarian platelet-rich plasma injection
Intervention groups
Granulocyte colony-stimulating factor(GCSF) 0.25 ml, filgrastim 300 mcg/0.5 ml subcutaneously every other day from 1 to 3 days of menstruation until the day of oocyte retrieval.Normal saline 1 ml every other day from 1 to 3 days of menstruation until the day of oocyte retrieval is given to the control group by subcutaneous injection every other day.
Main outcome variables
Expression of genes BMP15, GDF9, FLT1 and HIF1; Number of mature MII oocytes; AMH and FSH of follicular fluid

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20241218064088N1
Registration date: 2025-02-03, 1403/11/15
Registration timing: registered_while_recruiting

Last update: 2025-02-03, 1403/11/15
Update count: 0
Registration date
2025-02-03, 1403/11/15
Registrant information
Name
Mehrnoosh Amanatbehbahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3231 5768
Email address
amanatbehbahani@sums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-01-29, 1403/11/10
Expected recruitment end date
2025-07-22, 1404/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the expression levels of BMP15, GDF9, FLT1 and HIF1 genes in granulosa cells of women with poor ovarian response under GCSF treatment with women with poor ovarian response receiving normal saline: a clinical trial
Public title
Comparison of expression levels of BMP15, GDF9, FLT1 and HIF1 genes in granulosa cells of women with poor ovarian response
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age group 20-40 years POSEIDON poor responder group 3 and 4 (expected poor responder group with AFC <5 and antimüllerian hormone (AMH) less than 1.1 ng/ml) Ovulation induction by GnRH antagonist protocol Normal parameters of semen Sperm intracytoplasmic injection Willingness to participate in the study and provide written informed consent Injection of platelet-rich plasma into the ovary
Exclusion criteria:
Contraindications for intracytoplasmic sperm injection(ICSI) treatment Contraindications to the use of granulocyte colony-stimulating factor and dydrogesterone Inability to fully comply with the study protocol In the last 3 months, G-CSF has been used for treatment
Age
From 20 years old to 40 years old
Gender
Female
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation method in this study will be the 4-way random permutation block method in such a way that A represents the person who intervenes and B represents the person who controls.This method considers quadruple blocks so that the total number of possible quadruple permutations is equal to 6,including:, ABAB، BABA، AABB، BBAA، ABBA، BAAB. Then, by using the table of random numbers and assigning a code from 0 to 9 to each of the permutations, the desired random list of 60 items, which includes 15 blocks of 4(4 x 15 = 60 total number of samples)produced and the order of assigning each of the methods to each of the samples participating in the study is determined. For example: (ABAB code 0, BABA code 1, AABB code 2, BBAA code 3, BAAB code 4 and ABBA code 5 to 9). Then, using the table of random numbers, a starting point is randomly selected and 15 numbers are randomly selected (row or column) and the permutation assigned to each number is noted.(The order of placement of permutations next to each other will be from left to right) and how to allocate the total 60 people to two groups A and B will be determined.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Zand Street, in front of Palestine Street, central building of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2024-11-20, 1403/08/30
Ethics committee reference number
IR.SUMS.REC.1403.347

Health conditions studied

1

Description of health condition studied
Poor ovarian response
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation

Primary outcomes

1

Description
GDF9 gene expression level in granulosa cells in GCSF and normal saline treated groups
Timepoint
The measurement of GDF9 gene expression in granulosa cells is at the end of the study and after collecting the follicular fluid of the entire sample volume.
Method of measurement
Polymerase Chain Reaction

2

Description
BMP15 gene expression level in granulosa cells in GCSF and normal saline treated groups
Timepoint
The measurement of BMP15 gene expression in granulosa cells is at the end of the study and after collecting the follicular fluid of the entire sample volume.
Method of measurement
Polymerase Chain Reaction

3

Description
The level of FLT1 gene expression in granulosa cells in GCSF and normal saline treated groups
Timepoint
The measurement of FLT1 gene expression in granulosa cells is at the end of the study and after collecting the follicular fluid of the entire sample volume.
Method of measurement
Polymerase Chain Reaction

4

Description
HIF1 gene expression level in granulosa cells in GCSF and normal saline treated groups
Timepoint
The measurement of HIF1 gene expression in granulosa cells is at the end of the study and after collecting the follicular fluid of the entire sample volume.
Method of measurement
Polymerase Chain Reaction

5

Description
Number of mature oocyte
Timepoint
After collecting the oocytes
Method of measurement
Counting in the laboratory

6

Description
Follicular fluid AMH
Timepoint
At the end of the study and after collecting the follicular fluid of the total sample volume
Method of measurement
Using the kit

7

Description
Follicular fluid FSH
Timepoint
At the end of the study and after collecting the follicular fluid of the total sample volume
Method of measurement
Using the kit

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: G-CSF (Granulocyte-colony stimulating factor) - 0.25 ml Filgrastim 300 mcg/0.5ml. Subcutaneous once every other day from day 1 to day 3 of the menstrual cycle until the day of oocyte retrieval. The number of times of use is 6 times in the ovulation stimulation cycle with the antagonist protocol. Poish Daroo Company
Category
Treatment - Drugs

2

Description
Control group: Normal saline 1 ml subcutaneously every other day from day 1 to day 3 of the menstrual cycle until the day of oocyte retrieval. The number of times of use is 6 times in the ovulation stimulation cycle with the antagonist protocol.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrat Zainab Hospital
Full name of responsible person
Somayeh Talebi Nesab
Street address
Intersection of Holy Defence - Hazrat Zainab Educational and Therapeutic Center
City
Shiraz
Province
Fars
Postal code
7153813311
Phone
+98 71 3726 6811
Fax
+98 71 3726 5252
Email
mehrnooshamanat@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hamid Mohammadi
Street address
Shiraz, Zand Street, in front of Palestine Street, central building of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 5410
Email
mehrnooshamanat@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mehrnoosh Amanatbehbahani
Position
Student
Latest degree
Master
Other areas of specialty/work
Reproductive Biology
Street address
Shiraz medical sciences dormiory,The alley 36/1,Zand sreet,Setad square
City
Shiraz
Province
Fars
Postal code
7135744661
Phone
+98 71 3231 5768
Fax
Email
amanatbehbahani@sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
mehrnooshamanatbehbahani
Position
student
Latest degree
Master
Other areas of specialty/work
Reproductive Biology
Street address
Karim Khan Zand Blvd., Street 36 (Dezhban), first branch, Imam Hassan (AS) dormitory complex
City
Shiraz
Province
Fars
Postal code
7135744661
Phone
+98 71 3231 5768
Email
mehrnooshamanat@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mehrnoosh Amanatbehbahani
Position
Student
Latest degree
Master
Other areas of specialty/work
Reproductive Biology
Street address
Shiraz medical sciences dormiory,The alley 36/1,Zand sreet,Setad square
City
Shiraz
Province
Fars
Postal code
7135744661
Phone
+98 71 3231 5768
Fax
Email
amanatbehbahani@sums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only a part of the data, such as the information related to the main result or the like, can be shared.
When the data will become available and for how long
Access starts 18 months after results are published
To whom data/document is available
Only for researchers working in academic and scientific institutes
Under which criteria data/document could be used
Comparative analyses
From where data/document is obtainable
Mehrnoosh Amanat Behbahani Contact number: 00989106070570 Email address: mehrnooshamanat@yahoo.com
What processes are involved for a request to access data/document
After receiving the request and reviewing the request, the answer will be given as soon as possible.
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