Acupuncture for Treatment of Patients With Poor Ovarian Response
Condition: Poor Ovarian Response; Accupuncture
Study type: Interventional

Summary: 
      This prospective randomized controlled trial is designed to investigate the effect of
      acupuncture on IVF/ICSI outcome in women with poor ovarian response. The study population
      consisted of all infertile women with a previous poor ovarian response who will undergo
      IVF/ICSI in Reproductive Biomedicine Research Center, Royan institute, Tehran Iran. To
      minimize the effect of ovarian stimulation protocol, a stratified randomization method
      according to ovarian stimulation protocols (GnRH agonist stopped and GnRH antagonist) is
      used.
    

Detailed description: 
      Poor ovarian response (POR) is a challenging issue in assisted reproduction treatment.
      Different controlled ovarian hyperstimulation protocols and strategies have been used in this
      group of women to improve reproductive outcome, but the success rate still remains low. The
      aim of this study was to determine the effect of acupuncture during ovulation induction on
      the results of IVF / ICSI cycles in patients with POR diagnosis. The study was approved by
      the institutional review board. Written, informed consent will be obtained from each
      participant. Infertile women with a diagnosis of POR, who undergoing the IVF / ICSI cycle are
      assigned to four groups by stratified randomization method according to ovarian stimulation
      protocol. Before the starting the treatment cycle, patients will be randomized with sealed
      randomization envelopes. The random allocation is concealed from the physician performing the
      IVF/ICSI treatment cycle. All patients will receive acupuncture by the same physician
      (Dr.Salimi). In experimental groups (A), 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. No sham acupuncture is considered in the control group for ethical and practical
      reasons. There is no intervention in the control groups (B).

      Controlled ovarian stimulation for patients in both groups will be performed according the
      long stopped protocol. GnRH agonist (Buserelin, 0.5 mg), beginning on day 18 of the previous
      cycle will be used for down regulation and then will be stopped on the starting ovarian
      stimulation. Ovarian stimulation will be done with recombinant FSH and hMG (225 IU
      recombinant FSH (Gonal-F®; Serono Laboratories Ltd., Geneva, Switzerland) and 75 IU hMG
      (Menopur®; Ferring). The doses of gonadotropins were adjusted as ovarian response in the
      ultrasound monitoring. Ovulation was triggered with hCG (10,000 IU) when at least three
      follicles have a diameter of 18 mm with an adequate serum E2 concentration.

      In both group, transvaginal oocyte retrieval will be performed under ultrasound guidance
      32-34 hours after hCG administration. Intracytoplasmic sperm injection will be performed for
      all metaphase II oocytes. Embryo transfer will be done under ultrasound guidance on day 3 for
      all patients.

      Primary consequences in this study are the total number of retrieved and MII oocytes and
      quality of the obtained embryos. Secondary outcomes are implantation and clinical pregnancy
      rates that confirmed by vaginal ultrasound (pregnancy sac and embryonic heart activity). The
      IVF/ICSI outcomes are compared in four groups. Data collection will be performed by using
      questionnaire to be filled as per the available records and laboratory results. Data analysis
      will be done through descriptive and perceptive statistical methods by using SPSS software
      version 20 for windows.
    

Intervention name(s): Accupuncture
Intervention type(s): Other
Intervention description(s): In experimental groups (A), 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. No sham acupuncture is considered in the control group for ethical and practical reasons
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment