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IRCT20080831001141N26 IRCT 2019-03-27 Royan Institute The effect of acupuncture for treatment of patients with poor ovarian response The effect of acupuncture on in vitro fertilization/ intracytoplasmic sperm injection embryo transfer outcomes in patients with poor ovarian response diagnosis: A randomized controlled trial 2018-04-21 anticipated 60 Complete https://irct.ir/trial/35081 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization method was designed by epidemiologist using STATA software version 13 and the number of blocks considered is 6. The random allocation list for patients was solely available to the epidemiologist. In order to hide the random allocation process, a total of 60 envelopes were 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 was selected based on the type of group mentioned in the envelope. N/A Poor ovarian response during controlled ovary stimulation in in vitro fertilization cycles. Intervention 1: Intervention group: acupuncture is done twice a week during the preceding cycle and the ovarian stimulation is performed by “gonadotropin releasing hormone (GnRH) agonist stopped protocol. All patients will receive acupuncture by the same physician (Dr.Salimi). In experimental groups, acupuncture will be applied for 30 minutes in each session and will be started from the month prior to onset of ovarian stimulation (two sessions of a weekly), and during the ovarian stimulation cycle (two sessions of a weekly), totally 7 acupuncture sessions will be carried out. Acupuncture will be performed using sterile needle on specific points (CV 3 (Zhongji), CV 4 (Guanyuan), ST 25 (Tianshu), ST 28 (Shuidao), ST 29 (Guilai), and LR 3 (Taichong), BL 23 (Shenshu), BL 32 (Ciliao), GV 20 (Baihui), GV 24 (Shenting), GB 13 (Benshen), ST 36 (Zusanli), SP 6 Sanyinjiao), SP 8, SP 10 and KI 3 (Taixi)). The needles were inserted to a depth of 15–30 mm, depending on the region of the body. Intervention 2: Control group: ovarian stimulation was performed by” GnRH agonist stopped protocol” without any other intervention. Yes - There is a plan to make this available What will be shared: Specific participant data sets are to be shared (e.g., all collected deidentified IPD, IPD collected for the primary outcome measure only, etc). When: starting 6 months after publication To whom: The study data only available for people working in academic institutions. Conditions: Data will be sent to the study in the case of correspondence between the research centers and the written request, if registered and referenced Where to obtain: Applicants must contact the scientific responsible through a contact number or email. How to obtain: After completing the correspondence with the academic officer and ensuring that the study data will be used by considering the right of authorship and reference, data will be sent within one to two weeks. Comments:
public Arezoo Arabipoor
Number 12, East Hafez Avenue, Bani Hashem Street, Resalat Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 16656-59911 +98 21 2356 2642 arezoo.arabipoor@gmail.com Royan Institute scientific Tayebeh Salimi
Number 12, East Hafez Avenue, Bani Hashem Street, Resalat Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 16656-59911. +98 21 2356 2218 tayebehsalimi@yahoo.com Royan Institute Iran (Islamic Republic of) Diagnosis of Poor ovarian response (POR), according to POSSEIDON group criteria (Group 3): Young patients (<35 years) with poor ovarian reserve pre-stimulation parameters (antral follicle count (AFC) <5, anti-Müllerian hormone <1.2 ng/mL). no limit 35 years Female Premature ovarian failure diagnosis Endometriosis grade III or IV Any contraindications to ovarian stimulation treatment Uterine infertility factor Previous history of ovarian surgery N98.2 Complications of attempted introduction of fertilized ovum following in vitro fertilization Treatment - Other Treatment - Other Intervention group: acupuncture is done twice a week during the preceding cycle and the ovarian stimulation is performed by “gonadotropin releasing hormone (GnRH) agonist stopped protocol. All patients will receive acupuncture by the same physician (Dr.Salimi). In experimental groups, acupuncture will be applied for 30 minutes in each session and will be started from the month prior to onset of ovarian stimulation (two sessions of a weekly), and during the ovarian stimulation cycle (two sessions of a weekly), totally 7 acupuncture sessions will be carried out. Acupuncture will be performed using sterile needle on specific points (CV 3 (Zhongji), CV 4 (Guanyuan), ST 25 (Tianshu), ST 28 (Shuidao), ST 29 (Guilai), and LR 3 (Taichong), BL 23 (Shenshu), BL 32 (Ciliao), GV 20 (Baihui), GV 24 (Shenting), GB 13 (Benshen), ST 36 (Zusanli), SP 6 Sanyinjiao), SP 8, SP 10 and KI 3 (Taixi)). The needles were inserted to a depth of 15–30 mm, depending on the region of the body. Control group: ovarian stimulation was performed by” GnRH agonist stopped protocol” without any other intervention. Total number of retrieved oocytes. Timepoint: 34–36 hours after final oocyte triggering. Method of measurement: The number of oocytes counted by an embryologist. Total number of MII oocytes. Timepoint: 34–36 hours final oocyte triggering. Method of measurement: The number of metaphase II oocytes counted by an embryologist. Implantation rate. Timepoint: 4-6 weeks after embryo transfer. Method of measurement: By dividing the number of gestational sacs by the number of embryos transferred. Clinical pregnancy rate. Timepoint: 5-7 weeks after embryo transfer. Method of measurement: By detection of fetal heart beat in vaginal sonography 5 - 7 weeks after transfer. Royan Institute Approved 2016-01-12 Ethics committee of Royan infertility institute Number 12, East Hafez Avenue, Bani Hashem Street, Resalat Highway, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)