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IRCT20201003048912N2 IRCT 2021-02-20 Avicenna University Jihad Infertility Center Avicenna Effect of Growth Hormone on Improve Pregnancy Rate in Women with poor ovarian response Effect of Growth Hormone on Improve Pregnancy Rate in Women with poor ovarian response 2020-06-21 anticipated 124 Complete https://irct.ir/trial/53763 observational Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Patients with poor ovarian response. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: Effect of Growth Hormone on Improve Pregnancy Rate in Women with poor ovarian response When: Up to one year after the publication of the article To whom: 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. Conditions: Using in meta-analysis studies Where to obtain: Marzdaran Town, Isar St., Motamedi St., Sahel Alley, No. 2 Avicenna University Jihad Infertility Center Dr. Mina Ataei Tell: 00982122432020 How to obtain: Email to corresponding author Dr Mina Ataei Ataee.mina@yahoo.com Comments:
public Dr. Mina Ataei
Marzdaran Town, Isar St., Motamedi St., Sahel Alley, No. 2
Tehran Iran (Islamic Republic of) 1941913114 +98 21 2243 2020 Atlee.mina@yahoo.com Avicenna University Jihad Infertility Center scientific Dr. Mina Ataei
Marzdaran Town, Isar St., Motamedi St., Sahel Alley, No. 2
Tehran Iran (Islamic Republic of) 1941913114 +98 21 2243 2020 Atlee.mina@yahoo.com Avicenna University Jihad Infertility Center Iran (Islamic Republic of) 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 20 years 40 years Female 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 N97 Female infertility Other Other 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. 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. 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. Avicenna University Jihad Infertility Center Avicenna Approved 2020-10-06 University Jihad Avicenna Infertility Center Tehran, Shariati St., corner of Yakhchal St., No. 97, Jihad University Avicenna Infertility Center Tehran Tehran Iran (Islamic Republic of)