The effect of oral melatonin supplementation on the number and quality of oocytes and embryos in infertile women with endometriosis and undergoing intracytoplasmic sperm insemination

The effect of oral melatonin supplementation on the number and quality of oocytes and embryos in infertile women with endometriosis undergoing intracytoplasmic sperm insemination (ICSI)

Randomized controlled trial with 2 parallel groups, triple blind, on 100 patients with endometriosis will be performed.The randomized block allocation method will be applied.

Data collection tools are patients records ,checklist. The checklist includes demographic and clinical information index that is completed during treatment cycles. Before and after the intervention, a vaginal ultrasound is performed by a gynecologist and the size of the endometrioma is recorded. Melatonin 5 mg and placebo are prescribed according to codes A and B. Patients, outcome assessors and Statistical analyzer are unaware of the allocation process.

Inclusion criteria are infertile women aged 20 to 40, under ART treatment along with a laparoscopy or ultrasound report indicating the presence of endometriosis in the file. Exclusion criteria: premature ovarian failure, severe male factor (according to WHO criteria, sperm count less than 15 million per milliliter and motility less than 50% and normal morphology less than 4%, occurrence of complications and drug sensitivity such as (fatigue, headache, blurred vision, nausea, diarrhea), diagnosis of adenomyosis, chronic diseases including thyroid, adrenal diabetes and current malignancy or history of malignancy, uterine myoma and PID, patients whose infertility is due to obstruction problems, genetic problems or hormonal problems.

Group A includes patients receiving melatonin and group B includes patients receiving placebo.

Oocyte number and quality, embryo number and quality and fertilization rate

The randomized block allocation method will be applied. The number of considered blocks is 4. Randomization will be done using a dedicated online randomization software (http://www.randomization.com). The allocation sequence is password protected and accessible only to an independent investigator not involved in the study.

The drug and placebo, which have the same size, color, taste, and smell, are provided to both groups in completely similar containers based on random allocation by the design partner. Therefore, none of the patients are aware of the assigned treatment and will not be informed until the end of the study. Also, the researcher evaluating the intended outcomes is unaware of the random allocation process and the type of treatment performed. In order to analyze the data, a statistician who is separate from the study process and is unaware of all the processes will be used.

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