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IRCT20110731007165N10 IRCT 2020-12-15 Tehran University of Medical Sciences Comparison of the effectiveness of GnRH agonist stop-Antagonist protocol versus GnRH antagonist protocol in IVF candidate patients Comparison of the effectiveness of GnRH agonist stop-Antagonist protocol versus GnRH antagonist protocol in poor respondent IVF candidate patients 2020-12-10 anticipated 74 Complete https://irct.ir/trial/52679 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization list will be prepared by a statistician using the block randomization method (using the site:www.sealedenvelope.com). Treatments will be placed in sealed envelopes and will be kept by the out-of-study nurse. After identification of the eligibility of the patient, the procedure will be explained to her and informed consent will be obtained. Then the treatment will be performed based on the kind of treatment in the envelope, Blinding description: Completion of the final information is up to the person who is unaware of the type of treatment and also the specialist will be blind. 3 Infertility. Intervention 1: Intervention group: GnRH(0.1 mg/daily) will be injected from mid-luteal phase until mense then in the second day of menstrual cycle recombinant FSH with LH will be injected. When the size of the follicle reaches 13-14 mm, the GnRH antagonist will be injected until trigger day. When the size of the follicle will reach above 18 mm HCG will be injected and 36 hours later ovarian puncture will be performed. Intervention 2: Group2:Ovarian stimulation with GnRH will be started from 2 days of the menstrual cycle. When the size of the follicle will reach above 13-14 mm GnRH antagonist (0.2 mg/daily) will be injected until trigger day. When the size of the follicle will reach above 18 mm HCG will be injected and 36 hours later ovarian puncture will be performed. One to three embryos will be transferred on the third day and luteal phase support is performed with progesterone. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It is not yet known if there will be a plan to make this available
public Ladan Kashani
Keshavarz Blvd.
Tehran Iran (Islamic Republic of) 1653915981 +98 21 8828 1866 kashani_ladan@tums.ac.ir Tehran University of Medical Sciences scientific Dr. Ladan Kashani
Arash Hospital, Rashid Street, Tehran Pars
Tehran Iran (Islamic Republic of) 1653915981 +98 21 7788 3195 Kashani_ladan@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) The criteria for diagnosing poor ovarian response are two of the following:1- Age 40 or older 2 - History of poor ovarian response (POR) in the previous cycle (oocyte less than 3 in a conventional protocol), 3-Antral follicle count (AFC) less than 5-7 or Anti-Müllerian hormone (AMH) <0.5-1.1. Twice poor ovarian response after maximal ovarian stimulation is sufficient reason to introduce the individual as POR without the need for other criteria. 40 years no limit Female Polycystic ovarian syndrome Hypothalamic amenorrhea Uterine congenital anomalies and uterine cavity abnormalities (Bicorn uterus, Unicorn uterus, Asherman, Liomyuma, Polyp, etc.) Repeated IVF failure (more than three consecutive failures) Endocrine disorders (diabetes, thyroid disease, antipolipid syndrome, cardiovascular and liver disease), N97 Female infertility Treatment - Drugs Treatment - Drugs Intervention group: GnRH(0.1 mg/daily) will be injected from mid-luteal phase until mense then in the second day of menstrual cycle recombinant FSH with LH will be injected. When the size of the follicle reaches 13-14 mm, the GnRH antagonist will be injected until trigger day. When the size of the follicle will reach above 18 mm HCG will be injected and 36 hours later ovarian puncture will be performed. Group2:Ovarian stimulation with GnRH will be started from 2 days of the menstrual cycle. When the size of the follicle will reach above 13-14 mm GnRH antagonist (0.2 mg/daily) will be injected until trigger day. When the size of the follicle will reach above 18 mm HCG will be injected and 36 hours later ovarian puncture will be performed. One to three embryos will be transferred on the third day and luteal phase support is performed with progesterone. Number of mature oocytes. Timepoint: During IVF process. Method of measurement: Embryologist opinion. Number of mature oocytes at retrieval. Timepoint: During IVF process. Method of measurement: Embryologist opinion. Embryo quality. Timepoint: Embryo formation. Method of measurement: By the embryologist. Oocyte count. Timepoint: Puncture Day. Method of measurement: by embryologist. Tehran University of Medical Sciences Approved 2020-10-31 Ethics Committee of Tehran University of Medical Sciences Qods St, Keshavarz Blvd, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)