]>
IRCT20220401054383N1 IRCT 2023-05-01 Vice-Chancellor's Office for Research of Sabzevar univercity The effect of Royal jelly on ovulation induction cycles in infertile women with polycystic ovary syndrome Comparison of the effect of treatment with metformin and metformin together with oral royal jelly on induction-ovulation cycles in infertile women with polycystic ovary syndrome. 2022-05-31 anticipated 110 Complete https://irct.ir/trial/63548 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this research, the allocation of samples to each group is done in a simple random manner, so that after confirming the inclusion criteria, we place the first person in the intervention or control group with a simple randomization model of lion or line by tossing a coin. (line in the intervention group and milk in the control group) and after that they will be placed in the middle of the intervention and control groups until the number of samples in the two groups is completed, Blinding description: The method of blinding in this study will be that before entering the study, eligible patients will be randomly assigned to one of groups A or B, and the demo graphic information of the desired group will be recorded in the questionnaire. After the visit and receiving the prescription, they are referred to the desired pharmacy and receive one of the packs A or B, which includes metformin + royal gel capsules, and the other pack includes metformin and placebo capsules. In this way, patients are not deprived of the main treatment and do not know about the complementary treatment. The researcher also does not know about the content of the pegs, and only in this research is the knowledgeable person a pharmaceutical consultant. 1-2 Polycystic ovarian syndrome +infertility. Intervention 1: Intervention group: We will give 55 members of the intervention group, who were randomly selected, one 1000 mlroyal gel capsule daily for 8 weeks along with other induction ovulation drugs.The capsules are prepared online from Positive Sabz Pharmacy and belong to the brand: OPD Pharma with product ID: 885595 and imported barcode: 6262248103293. Intervention 2: Control group:Members of the control group only receive ovulation induction drugs and metformin. Yes - There is a plan to make this available What will be shared: The results of the data will be published in the form of articles and the information of the participants will remain confidential. When: The beginning of 1400 and the end of 1402 To whom: Accessible to the public Conditions: Fisher's chi-square and Mann-Whitney statistical tests and.. Where to obtain: Can be published on official sites How to obtain: After the defense in the faculty, it will be published as an article Comments:
public Mehri Sakhdari
North Kashfi St
Sabzevar Iran (Islamic Republic of) 9613856776 +98 51 4423 8100 Mobini.h@medsab.ac.ir Sabzevar University of Medical Sciences scientific Mehri Sakhdari
No. 204, Fazal St
Nishaboor Iran (Islamic Republic of) 9318788571 +98 51 4261 6208 mehri.sakhdari@yahoo.com Sabzevar University of Medical Sciences Iran (Islamic Republic of) Polycystic ovary syndrome has been confirmed using the Rotterdam criteria normal hystrosalpyngography Husband's spermogram should be normal Have not been subjected to ovulation induction have completed the informed consent form to participate in the research 18 years 40 years Female Any medication for induction dissatisfaction Non-confirmation of polycystic ovary syndrome using the Rotterdam criteria E28.2 Polycystic ovarian syndrome Treatment - Drugs Treatment - Drugs Intervention group: We will give 55 members of the intervention group, who were randomly selected, one 1000 mlroyal gel capsule daily for 8 weeks along with other induction ovulation drugs.The capsules are prepared online from Positive Sabz Pharmacy and belong to the brand: OPD Pharma with product ID: 885595 and imported barcode: 6262248103293. Control group:Members of the control group only receive ovulation induction drugs and metformin The size of the follicles:the size of one or more follicles has reached 18-22 mm. Timepoint: Examination at the beginning of the study and after 8 weeks of receiving the drug. Method of measurement: Transvaginal ultrasound , positive pregnancy test. Vice-Chancellor's Office for Research of Sabzevar univercity Approved 2022-03-14 Sabzevar University of Medical Sciences North Kashfi St Sabzevar Razavi Khorasan Iran (Islamic Republic of)