Determining the effect of growth hormone on increasing the rate of successful pregnancy in patients with poor ovarian response
Design
Single-blind randomized double-arm clinical trial study in two groups of growth hormone and no-growth hormone receiving patients with poor ovarian response
Settings and conduct
In this prospective study by clinical trial method, patients with poor ovarian response as Blocked Randomization are divided in two groups, receiving 4 units of growth hormone subcutaneous daily from 21st day of menstruation before starting the cycle to the day of trigger injection and control group without receiving growth hormones. Single blinding is done for researchers conducting the study. Data collection authorities and those evaluating the outcome do not have access to patients’ files or patients' clinical report forms.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age less than 40 years, Normal karyotype, Normal thrombophilia (having two or less than two positive tests for thrombophilic heterozygotes), Formation of 5 embryos (more than 3 embryos with good quality).
Exclusion criteria: Endometriosis disease, Severe oligospermia (morphology count <1%), Patients with hydrosalpinx
Intervention groups
The intervention group includes patients with poor ovarian response who receive growth hormone intervention.
The control group includes patients with poor ovarian response who do not receive growth hormone intervention.
Main outcome variables
Clinical pregnancy by defining the observation of pregnancy sac on transvaginal ultrasound in the 5th week of pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201003048912N2
Registration date:2021-02-20, 1399/12/02
Registration timing:registered_while_recruiting
Last update:2021-02-20, 1399/12/02
Update count:0
Registration date
2021-02-20, 1399/12/02
Registrant information
Name
Mina Ataei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2020
Email address
m.ataee@abz.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Growth Hormone on Improve Pregnancy Rate in Women with poor ovarian response
Public title
Effect of Growth Hormone on Improve Pregnancy Rate in Women with poor ovarian response
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age less than 40 years,
Normal karyotype,
Normal thrombophilia (having two or less than two positive tests for thrombophilic heterozygotes)
Formation of 5 embryos (more than 3 embryos with good quality)
Patients with poor ovarian response (history of an ovulation stimulation cycle with less than 4 oocytes and AMH <1.1 and FSH <20) in infertile women referred to Ibn Sina Infertility Treatment Center
Exclusion criteria:
Endometriosis disease
Severe oligospermia (morphology count <1%)
Patients with hydrosalpinx
History of ovarian surgery
Underlying disease such as kidney and liver and diabetes and thyroid autoimmune
Allergic local reactions and benign increase in intracranial pressure
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
124
Randomization (investigator's opinion)
Randomized
Randomization description
The s ampling method was convenient and the samples were randomly assigned to two groups of received Growth Hormone counseling (intervention) and non-received Growth Hormone counseling (control) by four-sized randomized blocks. There were six possibiliti es for inclusion in blocks (BABA, BBAA, ABBA, AABB, ABAB and BAAB). At the beginning of study, one of blocks was selected and four participants were put in that block, so that the number A belonged to the intervention group (GH), and number B to the control group (Non GH). The details of blocks were contained in asset of sealed envelopes; the person that did allocation did not have any information about research. random numbers form with the help of computers. If the number is between 1 and 6.1, block 1. If it is between 6.2 and 12, block 2 and continue this way up to 30.1-36.2 to be in block 6.
Blinding (investigator's opinion)
Single blinded
Blinding description
The researchers responsible for data collection and those who assess outcomes will not have access to patients’ medical records and clinical report forms. They will simply collect patients’ outcomes based on the initial list for participation in the research. These people will not be aware of the type of assignment of participants to the control and intervention group
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
University Jihad Avicenna Infertility Center
Street address
Tehran, Shariati St., corner of Yakhchal St., No. 97, Jihad University Avicenna Infertility Center
City
Tehran
Province
Tehran
Postal code
1941913114
Approval date
2020-10-06, 1399/07/15
Ethics committee reference number
IR.ACECR.AVICENNA.REC.1399.018
Health conditions studied
1
Description of health condition studied
Patients with poor ovarian response
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Pregnancy rate
Timepoint
Three months after taking the drug
Method of measurement
The number of patients with BHCG positive is divided by the number of patients who had fetus transfer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients will receive 4 units of subcutaneous growth hormone of Sinagen Company from the 21st day of menstruation, one month before the start of cycle to the day of trigger hug injection. From the third day of menstruation, the patient will receive a gonadotropin injection and an antagonist protocol according to the routine of Ibn Sina Infertility Center, and it continues until the day of the growth hormone trigger injection; 36 hours after trigger injection, they will be punctured and according to endometrial conditions, they will routinely be undergone frozen or fresh embryo transfer.
Category
Other
2
Description
Control group: Patients without receiving growth hormone from the third day of menstruation receive gonadotropin injection and antagonist protocol according to the routine of Ibn Sina Infertility Center and it continues until the day of growth hormone trigger injection; 36 hours after trigger injection, they are punctured and according to endometrial conditions, they are routinely undergone to frozen or fresh embryo transfer.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Jihad University Research Institute, Avicenna Infertility Center
Full name of responsible person
Soheila Ansaripour
Street address
Shariati St., corner of Yakhchal St., No. 97, Jihad University , Avicenna Infertility Center
City
Tehran
Province
Tehran
Postal code
1941913118
Phone
+98 21 2243 2020
Fax
+98 21 2243 2022
Email
soh.ansaripour@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Avicenna University Jihad Infertility Center Avicenna
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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Effect of Growth Hormone on Improve Pregnancy Rate in Women with poor ovarian response
When the data will become available and for how long
Up to one year after the publication of the article
To whom data/document is available
Access to the effect of chemical and clinical pregnancy rates after receiving growth hormone will be available to other researchers and physicians in coordination with the principal investigator.
Under which criteria data/document could be used
Using in meta-analysis studies
From where data/document is obtainable
Marzdaran Town, Isar St., Motamedi St., Sahel Alley, No. 2 Avicenna University Jihad Infertility Center Dr. Mina Ataei Tell: 00982122432020
What processes are involved for a request to access data/document
Email to corresponding author Dr Mina Ataei Ataee.mina@yahoo.com