Comparison of the effect of gonadotropin-releasing hormone GnRH agonist administration with GNRH antagonist protocol on assisted reproductive methods in patients with reduced ovarian response.

Investigating the effect of gonadotropin-releasing hormone (GnRH) administration in the cycle before intracytoplasmic sperm injection (ICSI) and in vitro fertilization (IVF) in poor responders.

This will be a two arm parallel group design of 50 patients candidate of intracytoplasmic sperm injection (ICSI) and in vitro fertilization (IVF) , single blind randomised trial, with a computer-generated randomization list with a block size of 4, with1:1 allocation.

Infertile women candidates of IVF/ICSI for different reason, having the study criteria who come to infertility clinic of Alzahra hospital will be entered into the study. ّFirst we will take an informed written consent and all part of the study will be explained to the patient. The treatment allocation will be placed in a sealed opaque envelope and picked up consecutively.

women with primary infertility and the criteria of poor ovarian response (based on BOLOGNA criteria) for IVF-ICSI are identified and in case of severe endometriosis or chronic disease, they will be prohibited from entering the study.

In the control group, intracytoplasmic sperm injection (ICSI) and in vitro fertilization (IVF) with usual gonadotropin-releasing hormone (GnRH) antagonist protocol, will be started and in the case group, patients will receive GNRH agonists in the luteal phase of pre-IVF-ICSI cycle (0.1 milligram every day for 10 to 12 days), and then the IVF-ICSI cycle will be started with the GNRH antagonist protocol.

The number and quality of the obtained oocytes

A computer-generated randomization list with a block size of 4, with 1:1 allocation will be used to randomize patients. In such a case, one control will be checked for each intervention and with each of the 4 patients enrolled in the study, the two groups are balanced in terms of control and intervention.50 matte and sealed envelope samples will be prepared. Randomization will be performed by a non-research person and The type of intervention will be written by random allocation on paper and placed inside the envelopes.Envelopes will be numbered from number 1 to the end.The first person will be given the first envelope and this will continue until the last desired number; There will be 25 people in group 1 and 25 people in group 2, for a total of 50 people.

In this study, the data analyst and outcome assessor will not know the type of drug. The possibility of blinding the patient and the doctor in order to respect the rights of the patients is not acceptable because it will require at least 13 painful injections under the skin with distilled water (with the same label as the drug), which is not ethically correct and has not been done in similar studies.