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IRCT20210405050852N1 IRCT 2021-06-10 Avicenna University Jihad Infertility Center Avicenna Effect of luteal phase stimulation with follicular phase stimulation in poor ovarian response Comparison of luteal phase stimulation with follicular phase stimulation in poor ovarian response 2021-07-01 anticipated 78 Complete https://irct.ir/trial/55402 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The Block randomization method was designed by an epidemiologist using STATA software version 13 and the number of blocks considered is 4. The random allocation list for patients was solely available to the epidemiologist. In order to hide the random allocation process, a total of 78 envelopes were prepared, and only the methodologist has been aware of the table of random numbers. When the doctor declared the patient's eligibility, the methodologist provided the doctor with the envelope. The group was selected based on the type of group mentioned in the envelope, Blinding description: This is a single-blind study. The participants don't aware about grouping name and type of treatment in each group. In order to blind the patients participating in this study, all conditions will be the same between the two groups, so patients in the intervention and control groups will refer to the center on ovulation stimulation days in both groups. 3 Poor ovarian response. Intervention 1: In this study, to compare the effect of luteal phase stimulation with follicular phase stimulation in patients with poor ovarian response, in the luteal phase group on days 15 to 16 of the menstrual cycle and when spontaneous ovulation is confirmed by transvaginal ultrasound and patients have one follicle at least 8 mm, start with 300 units of FSH plus 150 to 225 units of HMG plus 10 mg of medroxyprogesterone daily. Medroxyprogesterone is used to delay mensturation and stop the release of oocytes during mensturation. GnRH antagonist is given when the largest follicle is> 12 mm. Sono examination will be performed every 24 to 72 hours. Blood hormones will also be tested by checking estradiol and progesterone levels on the day of ovulation stimulation. Ovulation stimulation will be administered using a GnRH agonist with 2 Human chorionic gonadotropins when at least one follicle <18 mm is seen. Oocyte collection will be done by transvaginal ultrasound 36 hours later. Fertilization will take place after oocyte retrieval. Successful fertilization is diagnosed when two pronuclei are seen about 18-20 hours after insemination. The embryos are then frozen on the third or fifth day, and in another cycle, the uterus is prepared for embryo transfer and the embryos are transferred. 14 days after the transfer of the fetus, the pregnancy test will be requested and the rate of chemical and clinical pregnancy will be evaluated. Intervention 2: Control group: In patients in the control group (follicular phase stimulation group), ovarian stimulation begins on the second or third day of the cycle with 300 units of FSH plus 150 to 225 units of HMG. GnRH antagonist is given when the largest follicle is> 12 mm. Ultrasound examination will be performed every 24 to 72 hours. Blood hormone analysis will also be done by checking estradiol and progesterone levels on the day of ovulation stimulation, and ovulation stimulation by GnRH agonist along with 2 Human chorionic gonadotropins will be administered when at least one follicle <18 mm is seen. Fertilization will take place after oocyte harvest. Successful fertilization is diagnosed when two pronuclei are seen about 18-20 hours after inoculation. The embryos are then frozen on the third or fifth day, and in another cycle, the uterus is prepared for embryo transfer and the embryos are transferred. 14 days after the transfer of the fetus, the pregnancy test will be requested and the rate of chemical and clinical pregnancy will be evaluated. Yes - There is a plan to make this available What will be shared: Comparison of luteal phase stimulation with follicular phase stimulation in poor ovarian response When: Up to one year after the publication of the article To whom: Other researchers and physicians Conditions: Use in meta-analysis studies Where to obtain: Avicenna infertility clinic, Dr. Mozhgan Vahabi datjerdi, 00982122644706 How to obtain: Email to the responsible author, Dr. Mozhgan vahabi Dastjerdi Comments:
public Mozhgan Vahabi Dastjerdi
No. 97, at the corner of the Yakhchal st, Shariati st, Tehran, Iran
Tehran Iran (Islamic Republic of) 1941913114 +98 21 2264 4706 Vahabi.mozhgan@yahoo.com Avicenna infertility clinic scientific Mozhgan Vahabi Dastjerdi
No. 97, at the corner of the Yakhchal st, Shariati st, Tehran, Iran
Tehran Iran (Islamic Republic of) 1941913114 +98 21 2264 4706 vahabi.mozhgan@yahoo.com Avicenna infertility center Iran (Islamic Republic of) History of an ovulation stimulation cycle with less than 4 oocytes AMH<1.1 ng/ml or AFC<5 The total number of motile sperm is at least 15 million Normal uterus in ultrasound and hysterosalpingography Regular periods of 21-35 days Indication for IVF Ability to participate and collaborate with study protocol Signature informed consent Under 40 years 18 years 39 years Female History of ovarian surgery History of pelvic cytotoxic radiation exposure due to malignancy History of recurrent miscarriage Grade III or IV endometriosis Concomitant uterine pathology (adenomyosis, submucosal myoma, Asherman syndrome) Autoimmune disease E28 Ovarian dysfunction Treatment - Drugs Treatment - Drugs In this study, to compare the effect of luteal phase stimulation with follicular phase stimulation in patients with poor ovarian response, in the luteal phase group on days 15 to 16 of the menstrual cycle and when spontaneous ovulation is confirmed by transvaginal ultrasound and patients have one follicle at least 8 mm, start with 300 units of FSH plus 150 to 225 units of HMG plus 10 mg of medroxyprogesterone daily. Medroxyprogesterone is used to delay mensturation and stop the release of oocytes during mensturation. GnRH antagonist is given when the largest follicle is> 12 mm. Sono examination will be performed every 24 to 72 hours. Blood hormones will also be tested by checking estradiol and progesterone levels on the day of ovulation stimulation. Ovulation stimulation will be administered using a GnRH agonist with 2 Human chorionic gonadotropins when at least one follicle <18 mm is seen. Oocyte collection will be done by transvaginal ultrasound 36 hours later. Fertilization will take place after oocyte retrieval. Successful fertilization is diagnosed when two pronuclei are seen about 18-20 hours after insemination. The embryos are then frozen on the third or fifth day, and in another cycle, the uterus is prepared for embryo transfer and the embryos are transferred. 14 days after the transfer of the fetus, the pregnancy test will be requested and the rate of chemical and clinical pregnancy will be evaluated. Control group: In patients in the control group (follicular phase stimulation group), ovarian stimulation begins on the second or third day of the cycle with 300 units of FSH plus 150 to 225 units of HMG. GnRH antagonist is given when the largest follicle is> 12 mm. Ultrasound examination will be performed every 24 to 72 hours. Blood hormone analysis will also be done by checking estradiol and progesterone levels on the day of ovulation stimulation, and ovulation stimulation by GnRH agonist along with 2 Human chorionic gonadotropins will be administered when at least one follicle <18 mm is seen. Fertilization will take place after oocyte harvest. Successful fertilization is diagnosed when two pronuclei are seen about 18-20 hours after inoculation. The embryos are then frozen on the third or fifth day, and in another cycle, the uterus is prepared for embryo transfer and the embryos are transferred. 14 days after the transfer of the fetus, the pregnancy test will be requested and the rate of chemical and clinical pregnancy will be evaluated. Number of metaphase II oocyte. Timepoint: End of ovarian stimulation. Method of measurement: Observation of metaphase 2 oocytes extracted by the embryologist. Chemical pregnancy rate. Timepoint: 14 days after transfer. Method of measurement: Beta-Human Chorionic Gonadotropin. Clinical pregnancy. Timepoint: Pregnancy 7th weeks. Method of measurement: Detect of fetal heart beat on ultrasound. Total number of embryos. Timepoint: After in vitro fertilization. Method of measurement: 18-20 hours after in vitro fertilization. Avicenna University Jihad Infertility Center Avicenna Approved 2021-03-09 Ethics Committee of Avicenna Research Institute (ARI) No. 97, at the corner of the Yakhchal st, Shariati st, Avicenna Infertility Clinic Tehran Tehran Iran (Islamic Republic of)