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IRCT20080831001141N30 IRCT 2020-12-23 ROYAN Institute Mild and minimal ovarian stimulation in patients with polycystic ovarian syndrome The comparison of four methods of ovarian stimulation with GnRH antagonist in patients with polycystic ovarian syndrome 2016-10-22 anticipated 120 Complete https://irct.ir/trial/53105 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization method is designed by epidemiologist using STATA software version 13 and the number of blocks considered is 8. The random allocation list for patients is solely available to the epidemiologist. In order to hide the random allocation process, a total of 120 envelopes are prepared, and only the methodologist has been aware of table of random numbers. When the doctor declared the patient's eligibility, the methodologist provided the doctor with the envelope. The group will be selected and based on the type of group mentioned in the envelope. N/A Polycystic ovarian syndrome. Intervention 1: Intervention group: The group of minimal ovarian stimulation with recombinant FSH. In this group, patients will receive 100 mg clomiphene citrate every day from Day 3 to Day 7 of the menstrual cycle and then will be treated with 150 IU Gonal-f (Follitropin alfa, Merck Serono, Germany) after the seventh day. Intervention 2: Intervention group: The group of minimal ovarian stimulation with human menopausal gonadotropin. In this group, patients will receive 100 mg clomiphene citrate every day from Day 3 to Day 7 of the menstrual cycle and then will be treated with 150 IU Merional (Highly Purified Menotropin، IBSA، Switzerland) after the seventh day. Intervention 3: Control group: The group of mild ovarian stimulation with recombinant FSH. In this group, patients that will receive 150 IU Gonal-f daily from Day 3 of the menstrual cycle. Intervention 4: Control group: The group of mild ovarian stimulation with human menopausal gonadotropin. In this group, patients that will receive 150 IU Merional daily from Day 3 of the menstrual cycle. Yes - There is a plan to make this available What will be shared: Clinical study report (published article) When: After the publication of the article To whom: Available to the public. Conditions: Scientific use by citing the source. Where to obtain: Dr. Firehouse Ghaffari Email: ghafaryf@yahoo.com How to obtain: Request via e-mail Comments:
public Firouzeh Ghaffari
Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway.
Tehran Iran (Islamic Republic of) 148- 16635 +98 21 2356 2647 ghafaryf@yahoo.com ROYAN Institute scientific Firouzeh Ghaffari
Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway.
Tehran Iran (Islamic Republic of) 148- 16635 +98 21 2356 2647 ghafaryf@yahoo.com ROYAN Institute Iran (Islamic Republic of) Infertile women with polycystic ovarian syndrome based on Rotterdam criteria Age 20-38 years Body Mass Index less than 30 Kg/m2 20 years 38 years Female Women with hematologic and autoimmune disorders Couples with chromosomal and genetic abnormalities Women with uterine anomalies Women with uterine and ovaries surgical history Women with endometriosis and adenomyosis Women with hydrosalpinx Women with uterine fibroids Severe male factor infertility (azoospermia) Women with recurrent abortion history Women with recurrent implantation failure history N97.9 Female infertility, unspecified Treatment - Other Treatment - Other Treatment - Other Treatment - Other Intervention group: The group of minimal ovarian stimulation with recombinant FSH. In this group, patients will receive 100 mg clomiphene citrate every day from Day 3 to Day 7 of the menstrual cycle and then will be treated with 150 IU Gonal-f (Follitropin alfa, Merck Serono, Germany) after the seventh day. Intervention group: The group of minimal ovarian stimulation with human menopausal gonadotropin. In this group, patients will receive 100 mg clomiphene citrate every day from Day 3 to Day 7 of the menstrual cycle and then will be treated with 150 IU Merional (Highly Purified Menotropin، IBSA، Switzerland) after the seventh day. Control group: The group of mild ovarian stimulation with recombinant FSH. In this group, patients that will receive 150 IU Gonal-f daily from Day 3 of the menstrual cycle. Control group: The group of mild ovarian stimulation with human menopausal gonadotropin. In this group, patients that will receive 150 IU Merional daily from Day 3 of the menstrual cycle. Live birth rate; live birth is defined in which a live fetus is delivered beyond 20 completed weeks of gestational. Timepoint: Only once; at least 20 weeks after embryo transfer. Method of measurement: Clinical information. NCT03876145 مرکز ثبت کارآزمایی های بالینی ایالات متحده امریکا (WWW.clinicaltrial.gov) ROYAN Institute Approved 2016-10-18 Ethics Committee of Royan Institute Royan Institute, Number 12, East Hafez Avenue, Banihashem Street, Resalat Highway. Tehran Tehran Iran (Islamic Republic of)