Comparison of the efficacy of dual trigger HCG and GnRH agonist compared to HCG only in women with poor response undergoing with antagonist protocol

Determining the effectiveness of hCG and GnRH agonist dual trigger compared to hCG alone in poor responders treated with antagonist protocol

The clinical trial will have a control group with parallel groups, a blind strain (blinding only in the outcome evaluation group), randomized on 152 patients, randomized by permutation block method. Individual randomization unit

Infertile women referring to Mahdiyeh Center will be randomly divided into two groups of double stimulation and single drug stimulation if they meet the inclusion criteria. In the double stimulation group, 36 hours before egg retrieval, GnRH agonist with the brand name Sinafect (buserlin) and HCG drug with the brand name Ovitrel will be injected subcutaneously. In the control group, only Ovitrel will be injected 36 hours before oocyte collection

Women of reproductive age (15 to 45 years) with poor ovarian response who have at least two of the following criteria according to the Bologna criteria will be included in the study. Age over 40 years (≥40 years), history of poor response with a maximum number of three oocytes obtained after stimulation or abnormal ovarian reserve confirmed by one of the two AFC tests less than or equal to 7 or AMH less than or equal to 1.2, also if not Criteria of advanced age or abnormal ovarian reserve, women will be eligible if they have a history of two poor responses after maximal ovarian stimulation. Eligible people will enter this project if they have informed consent to enter the study. People whose spouse has azoospermia or who have PCOS themselves are excluded from the study.

Intervention group: double ovarian stimulation with HCG and GnRH agonist simultaneously Control group: ovarian stimulation only with HCG

Chemical pregnancy Clinical pregnancy The number of oocyte retrived

The block randomization method will be permutation. Individual randomization unit and block size is 4. The intervention will be repeated twice in each block of each group. As a result, we will have 6 different blocks, each of which will be numbered arbitrarily from 1 to 6. Then, using the code of the statistical program in the R software environment version 3.6.1, 38 blocks of 4 will be produced, which will produce a sequence of size 152 in total. Using this list, patients will be assigned to the HCG stimulation or dual stimulation group.

Due to the fact that the specialist doctor is aware of the type of intervention, it is not possible to blind the doctor in this study. According to the number of injections and the type of medicine, the patient will know in which group she belongs, so the patient will not be blinded. Blinding will only be possible for the outcome evaluation group, so that the results will be sent to this group in the form of codes A and B, and it will not be clear whether group A is the test group or the control group.