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IRCT20140818018842N14 IRCT 2018-08-11 Deputy of Research and Technology, Tehran University of Medical Sciences. “Effect of treatment with growth hormone in infertility” The randomized single-blinded clinical trial comparing growth hormone effect versus placebo on Improving the outcome of pregnancy in infertile patients. 2016-04-20 anticipated 105 Complete https://irct.ir/trial/16976 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are divided into 3 study groups by balanced block randomization. The list of randomized patients is made by a person not involved in the study and then the participants are randomly assigned into treatment groups, Blinding description: Patients recruited into trial after signing inform consent and assessing inclusion and exclusion criteria, randomly assigned to three groups A, B and C by a person not involved in the study, according to randomization patients will received drug (growth hormone or placebo), in the same package based on the protocol, the physician knows what treatment has been used but data analyzer is blinded. 3 poor ovarian response. Intervention 1: Intervention group 1: received Gonadotropin (Gonal-f 300 to 450 IU/day, subcutaneously, based on age and follicular count) from the third day of the cycle plus GnRH antagonist (Cetrotide, 0.25mg/day, subcutaneously, after production of 14mm follicles) and growth hormone(Somatropin, 2.5mg/day, subcutaneously)from the eight day of the cycle for about 5 days. Intervention 2: Intervention group 2: received Gonadotropin (Gonal-f 300 to 450 IU/day, subcutaneously, based on age and follicular count) from the third day of the cycle plus GnRH antagonist (Cetrotide, 0.25mg/day, subcutaneously, after production of 14mm follicles) and growth hormone (Somatropin, 0.1mg/day, subcutaneously) from the third day of the previous cycle for about 20 days. Intervention 3: Intervention group 3: received Gonadotropin (Gonal-f 300 to 450 IU/day, subcutaneously, based on age and follicular count) from the third day of the cycle plus GnRH antagonist (Cetrotide, 0.25mg/day, subcutaneously, after production of 14mm follicles) and placebo (Normal saline 1ml/day, subcutaneously, uniformed to Somatropin) from the eight day of the cycle for about 5 days. Yes - There is a plan to make this available What will be shared: All data is published after being unidentified. When: starting 12 months after publication. To whom: available for people working in academic institution and people working in businesses can also apply to receive it. Conditions: The requirements for submitting a request for access to data and documentation include: - Certificate from university and research institutes - Field is a researcher related subject. - The focus of the people working in the industry on the subject matter. Where to obtain: Access to information by sending an email to the following address may: asamaei@razi.tums.ac.ir How to obtain: The receipt of the data after the submission of the documentation will be received up to a month after the submission of the request. Comments:
public Atefe Samaei
Tehran University of Medical Science. Keshavarz Boulevard, North Kargar, Tehran Town.
Tehran Iran (Islamic Republic of) 1417653761 +98 21 84901 asamaei@razi.tums.ac.ir Tehran University of Medical Sciences scientific Atefeh Samaei
Shariati Hospital, North Kargar Ave.
Tehran Iran (Islamic Republic of) 1417653761 +218 4901 asamaei@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Sign the informed consent form Patients with poor ovarian response based on criteria provided by the Union embryology and infertility Europe 2011. Strong history of poor ovarian response (Having a maximum of three ovum after inducing ovulation protocols) Low score ovarian reserve (AFC less than 7, AMH less than 0.5-1.1 ng/ml) 20 years 50 years Female Women with high levels of FSH (more than 20 IU/L) Women with a history of infertility due to known non poor ovarian resonce Women with diabetes (type I or II) N97.0 Female infertility associated with anovulation Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group 1: received Gonadotropin (Gonal-f 300 to 450 IU/day, subcutaneously, based on age and follicular count) from the third day of the cycle plus GnRH antagonist (Cetrotide, 0.25mg/day, subcutaneously, after production of 14mm follicles) and growth hormone(Somatropin, 2.5mg/day, subcutaneously)from the eight day of the cycle for about 5 days. Intervention group 2: received Gonadotropin (Gonal-f 300 to 450 IU/day, subcutaneously, based on age and follicular count) from the third day of the cycle plus GnRH antagonist (Cetrotide, 0.25mg/day, subcutaneously, after production of 14mm follicles) and growth hormone (Somatropin, 0.1mg/day, subcutaneously) from the third day of the previous cycle for about 20 days. Intervention group 3: received Gonadotropin (Gonal-f 300 to 450 IU/day, subcutaneously, based on age and follicular count) from the third day of the cycle plus GnRH antagonist (Cetrotide, 0.25mg/day, subcutaneously, after production of 14mm follicles) and placebo (Normal saline 1ml/day, subcutaneously, uniformed to Somatropin) from the eight day of the cycle for about 5 days. The follicle number obtained in the ART cycle. Timepoint: Before starting treatment, on day eighth of a cycle, 36 hours after injecting HCG. Method of measurement: Trans vaginal ultrasonography. The number of metaphase II follicles achieved in the ART cycle. Timepoint: According embryologist report at ovum puncture. Method of measurement: Count of meta-phase II follicles in embryologist ward by microscopic observation. The number of quality embryos obtained from the ART cycle. Timepoint: Third and fifth day after fertilization in the laboratory. Method of measurement: Report embryologists based grading A, B, C. The number of positive pregnancy test. Timepoint: 14 days after embryo transfer. Method of measurement: BHCG over than 40 IU. Successful clinical pregnancy. Timepoint: 6 to 8 weeks after embryo transfer. Method of measurement: Fetal Heart in Transvaginal ultrasonography. Deputy of Research and Technology, Tehran University of Medical Sciences. Approved 2016-12-07 Ethics Committee of Tehran University Medical Sciences Ethics Committee of Tehran University of Medical Sciences, Keshavarz Boulevard, Tehran town. Tehran Tehran Iran (Islamic Republic of)