The comparison of efficacy and outcomes of Triptorelin (Diphereline®) and hCG in ovulation trigger in infertile women with poly cystic ovarian syndrome in IUI cycle: A randomize clinical trial study

To evaluate the effect of two agonists, GnRH (Diphereline) and hCG, on pregnancy.

A control group, community-based and prospective, with parallel groups (intervention and control), randomized, one-step, sample size of 120 people, subjects simple random method using a table of random numbers.

In this study, which is done in the educational-medical center of Jahrom, the treatment required to stimulate ovulation includes two Letrozole (2.5 mg) that will be given from the third to the seventh day of the menstrual cycle and the eighth day of the cycle. The patient will have a trans vaginal sonography. If the size of the follicles is less than 18 mm, we will do an ultrasound again on day 12 of the cycle, and based on the size of the follicles and the diameter of the endometrium (three layers, transparent, echogenic), if the desired follicle was between 18-22 mm, to release the egg. One group is given two-tenths of a micro-gram of Diphereline and the other group is injected with 10,000 units of hCG .

Inclusion criteria: infertile women with PCOS aged 15 to 45 years who did not become pregnant one year after intercourse without the use of contraceptives. Non-Inclusion criteria: Age over 45 years, presence of myoma, FSH> 12, endometriosis, history of contact with any substance induced previous ovulation, any contraindication both Diphereline and hCG

In this study, we have two groups of intervention and control. In the intervention group, we investigated the effect of GnRH agonist (Diphereline) on pregnancy with minimal complications in people with poly cystic ovary syndrome compared to hCG in the control group. In the control group, the common drug, hCG, is used.

Pregnancy, multiple births, ovarian hyper stimulation syndrome, drug side effects

In this study, computerized block randomization (blocks size 3 and 9) will be performed, which is the randomization unit, individual and layers of randomization, age of people and randomization tools, table of random numbers. An independent clinical epidemiologist who is not involved in the study will use a randomized blockchain program (STATA14 software) to generate allocation codes. Random sequences will be placed in light-resistant envelopes and sealed. The research assistant will open sealed, numbered and opaque envelopes containing the assignment codes. Eligible participants, after signing the informed consent form, will be divided into two equal groups (hCG group and Diphereline group).