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Study aim
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To assess the effect of oral contraceptive with gonadotropin-releasing hormone (GnRH) agonist versus Estradiol Valerate on the pregnancy continuity after a frozen embryo transfer in infertile women
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Design
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This is a double-blind randomized clinical trial, phase II, in which 100 eligible patients will be randomly assigned to the intervention and control groups
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Settings and conduct
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The eligible infertile women referring to the Fatemieh Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the block randomization. This trial will be double-blinded so that neither patients nor the physician examining the patients will be aware of the intervention.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Age of 18 to 40 years,
Infertile women candidate for the embryo transfer process,
Having more than 3 embryos for transfer,
Having a healthy uterine cavity,
Having constant embryo culture medium,
Having a constant embryo transfer environment,
Having constant fetal quality,
Having fixed embryology,
Exclusion criteria:
Being a smoker,
Idiopathic infertility,
Patients with donated oocytes,
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Intervention groups
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Intervention group:
Oral contraceptive pill once daily form the second day of the menstrual cycle for 12 days plus a subcutaneous injection of GnRH agonist 0.5 mg daily from the 15th day of the menstrual cycle for 14 days
Control group:
Estradiol Valerate tablet (manufactured by Abureihan Pharmaceutical Co.) 6 mg twice a day from the second day of the menstrual cycle for at least 10 days
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Main outcome variables
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Primary outcome:
Pregnancy continuity,
Secondary outcome:
Ectopic pregnancy, polygamous pregnancy, spontaneous abortion