Comparison of clomiphene citrate and Cetrotide in IVF (In Vitro Fertilization)cycles to prevent LH surge and pregnancy results.

Comparison of clomiphene citrate and Cetrotide in IVF (In Vitro Fertilization)cycles to prevent LH surge and pregnancy results.

Clinical trial with control and intervention group, with parallel groups, unblinded, randomized, phase 3 on 68 patients. Randomization will be done by block randomization method.

This study will be conducted in the field of infertility treatment on 68 patients referred to the infertility clinic of Alzahra Hospital in Tabriz. Patients will be randomly divided into two groups of 34 people. The control group will receive 0.25 mg/d of sterotide subcutaneously, and the intervention group will receive clomiphene citrate 150 mg daily.

Infertile women with the age of 20-40 years will enter the study and in case of endometriosis grade 3 and 4, they will be prohibited from entering the study.

In the intervention group, clomiphene citrate 150 mg will be prescribed to the patient daily from the time of observation of the follicle with a diameter of 13 mm. Follicular monitoring will be done on the fifth to sixth day of stimulation by ultrasound. When 3 follicles above 17 mm are observed, 10,000 international units of hCG will be prescribed for final egg maturation and ovulation.In the control group, the stimulation will be done by gonadotropin from the third day of menstruation. A transvaginal ultrasound will be performed 5-6 days after gonadotropin stimulation, and then repeated every 2-3 days according to the patient's condition. Cetrotide 0.25 mg/d will be injected subcutaneously when the follicular diameter reaches 13-14 mm. When 3 follicles with a diameter greater than 17 mm are observed, 10,000 IU of hCG will be used for final egg maturation and ovulation stimulation.

Pegnancy outcome were considered as the main outcome.

The participants will be assigned to two intervention and control groups based on the randomization sequence that will be generated in advance. This sequence is unpredictable and its arrangement is completely random. Block randomization method with 4 and 6 blocks will be used to allocate the samples. In this way, by using the block method random number generation software, the randomization sequence will be produced according to the required sample size for two groups. In the beginning, all the modes in which 2 letters A and B can be put together in blocks of 4 and 6 are produced. Then a block will be selected randomly and by placement among the blocks, and the arrangement pattern in that block will be used to allocate the participants. Then this block will be placed in the main container and another block will be selected again. All these works will be done with a software called Sealed Envelope. Using this method, concealment will also be observed. The concept of concealment is the unpredictability of assigning people to groups. In fact, the researcher will not be able to predict which group the next person will be in.