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IRCT201312251141N16 IRCT 2015-02-12 Royan Institute Comparison of ART Outcomes between Two Protocols of Induction of ovulation in Patients with Hypogonadotropic Hypogonadism Compare the efficacy of two protocols of ovarian stimulation using Gonal-F and Luveris in women with hypogonadotropic hypogonadism undergoing assisted reproductive technique Compare the efficacy of two protocols of ovarian stimulation using Gonal-F and Luveris in women with hypogonadotropic hypogonadism undergoing assisted reproductive technique 2012-11-13 anticipated 90 Complete https://irct.ir/trial/209 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 4 • Female infertility associated with anovulation. Intervention 1: Intervention: Patients receive treatment with Gonal-F (starting dose 150 IU subcutaneously once daily and from day 2-3 according to the ovarian response) and Luveris (fixed dose of 75 IU subcutaneously once daily). When at least one follicle reaches 14 mm in diameter, intervention group continue Luveris alone. Intervention 2: Control: Patients receive treatment with Gonal-F (starting dose 150 IU subcutaneously once daily and from day 2-3 according to the ovarian response) and Luveris (fixed dose of 75 IU subcutaneously once daily). When at least one follicle reaches 14 mm in diameter, control group continue treatment with both drugs (Gonal-F/Luveris).
public Tahereh Madani
Royan Institute, Number 12, East Hafez Avenue, Bani Hashem Street, Resalat high way, Tehran, Iran
Tehran Iran (Islamic Republic of) +98 21 2356 2640 tmadani@royaninstitute.org Royan Institute scientific Tahereh Madani
Royan Institute, Number 12, East Hafez Avenue, Bani Hashem Street, Resalat high way, Tehran, Iran
Tehran Iran (Islamic Republic of) +98 21 2356 2640 Tmadani@royaninstitute.org Royan Institute Iran (Islamic Republic of) Inclusion Criteria: Have a clinical history of hypogonadotropic hypogonadism, and laboratory test result comply with diagnosis of hypogonadotropic hypogonadism; Have discontinued gonadotropins or gonadotropin releasing hormone or estrogen-progesterone replacement therapy at least one month before the study; Have primary or secondary amenorrhea; Serum LH and FSH <5.0 IU/l and oestradiol <100 pg/ml before initiation of treatment; Have a negative progesterone challenge test; Normal serum concentrations of thyroid stimulating hormone (TSH), prolactin and testosterone within 6 months before the start of study; Have given written informed consent prior to any study related procedure Exclusion Criteria: The other causes of infertility; History of ovarian hyper stimulation syndrome; Abnormal gynecological bleeding of undetermined origin; Previous or current hormone dependent tumor no limit no limit Female E23.0 Hypopituitarism Treatment - Drugs Treatment - Drugs Intervention: Patients receive treatment with Gonal-F (starting dose 150 IU subcutaneously once daily and from day 2-3 according to the ovarian response) and Luveris (fixed dose of 75 IU subcutaneously once daily). When at least one follicle reaches 14 mm in diameter, intervention group continue Luveris alone. Control: Patients receive treatment with Gonal-F (starting dose 150 IU subcutaneously once daily and from day 2-3 according to the ovarian response) and Luveris (fixed dose of 75 IU subcutaneously once daily). When at least one follicle reaches 14 mm in diameter, control group continue treatment with both drugs (Gonal-F/Luveris). The number and size of follicles. Timepoint: Before injection of hCG. Method of measurement: Sonography. Endometrial thickness. Timepoint: Day of injection of hCG. Method of measurement: Sonography. The number of oocytes retrieved. Timepoint: 34-36 hours after hCG injection. Method of measurement: Sonography. Fertilization. Timepoint: 2-3 days before the embryo transfer. Method of measurement: observation of 2 pro-nuclei (2PN). Biochemical pregnancy. Timepoint: 2 weeks after embryo transfer. Method of measurement: BhCG test. Clinical pregnancy. Timepoint: 4-6 weeks after embryo transfer. Method of measurement: Ultrasound visualization of a gestational sac. Implantation. Timepoint: 4-6 weeks after embryo transfer. Method of measurement: Number of gestational sacs by Sonography. Royan Institute Approved 2012-09-25 Royan Institute.rg Royan Institute, Number 12, East Hafez Avenue, Bani Hashem Street, Resalat high way, Tehran, Iran tehran Iran (Islamic Republic of)