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IRCT20170205032406N2 IRCT 2018-10-15 Babol University of Medical Sciences The effect of dydrogesterone and vaginal progestrein in support of artificial reproduction techniques Comparison of the efficacy of two therapeutic methods of use of dydrogesterone and vaginal progestrein as a luteal cycles support in Assisted Reproductive Technology (ART) in patients referring to Fateme Zahra infertility center in Babol 2018-10-02 anticipated 210 Complete https://irct.ir/trial/34294 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment of the patients into two intervention groups Patients are randomly divided into two groups A (dydrogesterone), B (vaginal progestin) with a table of random number s (a random number table is a collection of numbers that are generated without a specific pattern or order and completely randomized, then samples are randomly selected by Randomizer software, Blinding description: The participants are unaware of the type of intervention (dydrogesterone or vaginal progestin) given to every participant. The medications are prepared quite similar in appearance (color and shape), sealed in opaque envelopes with consecutive numbers. The researcher is aware of numbers. N/A In vitro fertilization. Intervention 1: Control group: Receives 400 mg vaginal suppository once a day began on the day of oocyte retrieval and was continued up to 12 weeks of pregnancy. Intervention 2: Intervention group: receives oral progesterone-duphaston 20 mg twice a day. began on the day of oocyte retrieval and was continued up to 12 weeks of pregnancy. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is still no plan for its puplish.
public Dr. Shahla Yazdani
Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
Babol Iran (Islamic Republic of) 47176-41367 +98 11 3223 8301 shahla_yazdani_1348@yahoo.com Babol University of Medical Sciences scientific Dr. Maryam Javadian Kotenae
Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
Babol Iran (Islamic Republic of) 47176-41367 +98 11 3223 8301 m.javadian@mubabol.ac.ir Babol University of Medical Sciences Iran (Islamic Republic of) 20-40 years old Body Mass Index 18-30 kg/m2 Endometrium Thickness 7-14 mm 20 years 40 years Female Abnormal prolactin serum level and abnormal thyroid function test Diminished ovarian reserve ( baseline FSH level >10 IU/mL) N98.2 Complications of attempted introduction of fertilized ovum following in vitro fertilization Treatment - Drugs Treatment - Drugs Control group: Receives 400 mg vaginal suppository once a day began on the day of oocyte retrieval and was continued up to 12 weeks of pregnancy. Intervention group: receives oral progesterone-duphaston 20 mg twice a day. began on the day of oocyte retrieval and was continued up to 12 weeks of pregnancy. Pregnancy. Timepoint: Once a week after embryo transfer into the patient. Method of measurement: The blood hCG test. Preterm delivery. Timepoint: Every two weeks from the twentieth week of pregnancy. Method of measurement: Patient visit and record uterine contractions. Amount of live birth. Timepoint: Every two weeks from twenty-eighth week of pregnancy. Method of measurement: Patient visit and record baby's birth. Abortion. Timepoint: Six weeks after intervention. Method of measurement: Sonography and pregnancy test. Babol University of Medical Sciences Approved 2018-09-16 Ethics committee of Babol University Of Medical Sciences Daneshgah Square, Ganjafrooz Avenue Babol Mazandaran Iran (Islamic Republic of)