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IRCT201409301556N64 IRCT 2014-10-11 Tehran University of Medical Sciences Effect of GnRH-a and OCP on the result of IVF in females with moderate and sever endomethriosis. Comparative study on the pregnancy outcomes of IVF between GnRH-a and OCP in women with moderate and sever endomethriosis. 2014-10-12 anticipated Complete https://irct.ir/trial/914 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2-3 Endomethriosis. Intervention 1: Hundred infertile women with mod and sever endomethriosis according to the revised American Fertility Society classification were scheduled for IVF. In interventional group(50) the patients takes OCP for 6-8 Weeks before IVF then received a standard controlled ovarian hyperstimulation (COH) regimen. It consisted of subcutaneous injections of 0.05 to 0.1 mg/day of a GnRH agonist (Diphereline 0.1 mg) for 7 to 10 days in the mid-luteal phase for pituitary down-regulation, and exogenous ovarian stimulation with gonadotropin was initiated on the second or third day after the onset of menstruation . Human chorionic gonadotropin (hCG) was administered to trigger egg maturation when at least 1 follicle achieved a mean diameter of 17 mm. The patients were scheduled for oocyte retrieval 34 to 36 hours after the hCG injection. Indications and techniques for oocyte aspiration, oocyte and embryo culture, insemination, intracytoplasmic sperm injection,, and embryo transfer were based on the routine of the center. Embryos were transferred at the 4- or 8- cell stage. Response to controlled ovarian hyperstimulation and IVF– ET cycle outcome were compared between groups. Clinical pregnancy was defined as an elevated serum hCG and the presence of a gestational sac on transvaginal ultrasound. Implantation rate was defined as number of ultrasonographically visualized gestational sacs per number of embryos transferred. Ongoing pregnancy was defined as a uterine pregnancy of more than 12 weeks' duration. Intervention 2: Hundred infertile women with mod and sever endomethriosis according to the revised American Fertility Society classification were scheduled for IVF . In control group(50) the patients received a 3.75-mg intramuscular injection of a GnRH agonist (Diphereline) twice, at a 28 days' interval. Controlled ovarian hyperstimulation was initiated within 10 days of the last GnRH agonist injection. Ovarian stimulation was achieved using FSH (Gonal-F;) and/or human menopausal gonadotropin . Human chorionic gonadotropin (hCG) was administered to trigger egg maturation when at least 1 follicle achieved a mean diameter of 17 mm. The patients were scheduled for oocyte retrieval 34 to 36 hours after the hCG injection. Indications and techniques for oocyte aspiration, oocyte and embryo culture, insemination, intracytoplasmic sperm injection,, and embryo transfer were based on the routine of the center. Embryos were transferred at the 4- or 8- cell stage. Response to controlled ovarian hyperstimulation and IVF– ET cycle outcome were compared between groups. Clinical pregnancy was defined as an elevated serum hCG and the presence of a gestational sac on transvaginal ultrasound. Implantation rate was defined as number of ultrasonographically visualized gestational sacs per number of embryos transferred. Ongoing pregnancy was defined as a uterine pregnancy of more than 12 weeks' duration.
public Mahboobeh Mohammadi
Arash Hospital, Rashid Ave, Tehranpars, Resalat Highway,Tehran
Tehran Iran (Islamic Republic of) +98 21 7788 8753 mahaoo58@yahoo.com Arash Hospital scientific Dr. Ladan Kashani
Arash Hospital, Rashid Ave, Tehranpars, Resalat Highway,Tehran
Tehran Iran (Islamic Republic of) +98 21 7788 8753 kashani-ladan@sina-tums.ac.ir Arash Hospital Iran (Islamic Republic of) Hundred infertile women with moderate and sever endomethriosis according to the revised American Fertility Society classification were scheduled for IVF. These patients were in line with: moderate and sever endometriosis; age less than 35 years old; FSH level below 10 U/L; 27>BMI>20. Exclusion criteria: minimal and mild endometriosis; potentialy poor responder; endocrine disorders. 20 years 35 years Female N80 Noninflammatory disorders of female genital tract Treatment - Drugs Treatment - Drugs Hundred infertile women with mod and sever endomethriosis according to the revised American Fertility Society classification were scheduled for IVF. In interventional group(50) the patients takes OCP for 6-8 Weeks before IVF then received a standard controlled ovarian hyperstimulation (COH) regimen. It consisted of subcutaneous injections of 0.05 to 0.1 mg/day of a GnRH agonist (Diphereline 0.1 mg) for 7 to 10 days in the mid-luteal phase for pituitary down-regulation, and exogenous ovarian stimulation with gonadotropin was initiated on the second or third day after the onset of menstruation . Human chorionic gonadotropin (hCG) was administered to trigger egg maturation when at least 1 follicle achieved a mean diameter of 17 mm. The patients were scheduled for oocyte retrieval 34 to 36 hours after the hCG injection. Indications and techniques for oocyte aspiration, oocyte and embryo culture, insemination, intracytoplasmic sperm injection,, and embryo transfer were based on the routine of the center. Embryos were transferred at the 4- or 8- cell stage. Response to controlled ovarian hyperstimulation and IVF– ET cycle outcome were compared between groups. Clinical pregnancy was defined as an elevated serum hCG and the presence of a gestational sac on transvaginal ultrasound. Implantation rate was defined as number of ultrasonographically visualized gestational sacs per number of embryos transferred. Ongoing pregnancy was defined as a uterine pregnancy of more than 12 weeks' duration. Hundred infertile women with mod and sever endomethriosis according to the revised American Fertility Society classification were scheduled for IVF . In control group(50) the patients received a 3.75-mg intramuscular injection of a GnRH agonist (Diphereline) twice, at a 28 days' interval. Controlled ovarian hyperstimulation was initiated within 10 days of the last GnRH agonist injection. Ovarian stimulation was achieved using FSH (Gonal-F;) and/or human menopausal gonadotropin . Human chorionic gonadotropin (hCG) was administered to trigger egg maturation when at least 1 follicle achieved a mean diameter of 17 mm. The patients were scheduled for oocyte retrieval 34 to 36 hours after the hCG injection. Indications and techniques for oocyte aspiration, oocyte and embryo culture, insemination, intracytoplasmic sperm injection,, and embryo transfer were based on the routine of the center. Embryos were transferred at the 4- or 8- cell stage. Response to controlled ovarian hyperstimulation and IVF– ET cycle outcome were compared between groups. Clinical pregnancy was defined as an elevated serum hCG and the presence of a gestational sac on transvaginal ultrasound. Implantation rate was defined as number of ultrasonographically visualized gestational sacs per number of embryos transferred. Ongoing pregnancy was defined as a uterine pregnancy of more than 12 weeks' duration Number of retrieved oocytes. Timepoint: Oocyte retrieval 34 to 36 hours after the hCG injection. Method of measurement: Base on microscopic finding. Number of MII oocytes. Timepoint: MII oocytes after retrieval. Method of measurement: Base on microscopic finding. Fertilization rate. Timepoint: Fertilization was assessed by pronuclei formation at 24 h after oocyte retrieval and by subsequent cleavage. Method of measurement: Base on microscopic finding. Implantation rate. Timepoint: Implantation rate was defined as number of ultrasonographically visualized gestational sacs. Method of measurement: Ultrasonography. The number of embryo transfer. Timepoint: Day 2 or day 3 embryos were transferred. Method of measurement: pationt's file. Clinical pregnancy. Timepoint: Ongoing pregnancy was defined as a uterine pregnancy of more than 12 weeks' duration. Method of measurement: Ultrasonography. Pregnancy rate per embryo transfer. Timepoint: pregnancy rate was defined as number of ultrasonographically visualized gestational sacs per number of embryos transferred. Method of measurement: ultrasonography. Tehran University of Medical Sciences Approved 2003-05-27 Tehran University of Medical Sciences Ethics Committee Tehran University of Medical Sciences, Ghods Avn., Keshavarz Blvd. Tehran Iran (Islamic Republic of)