The Four Methods of Ovarian Stimulation in Patients With Polycystic Ovarian Syndrome
Condition: Polycystic Ovary Syndrome; Ovarian Hyperstimulation Syndrome
MeSH terms: Polycystic Ovary Syndrome; Ovarian Hyperstimulation Syndrome; Syndrome
Study type: Interventional

Summary: 
      This study is a randomized controlled clinical trial to compare the pregnancy outcomes of
      mild and minimal stimulation in infertile women with polycystic ovarian syndrome. The study
      population consisted of all infertile women with polycystic ovary syndrome based on Rotterdam
      criteria who have not succeed to achieve fertility despite multiple treatments such as drug
      therapy, laparoscopic surgery, and the frequent failure of induction therapy using
      gonadotropins and are now candidate for in vitro fertilization (IVF) or intra cytoplasmic
      sperm injection (ICSI) in Reproductive Biomedicine Research Center, Royan institute, Tehran
      Iran.
    

Detailed description: 
      An overview of the history of assisted reproductive technologies such as IVF and ICSI that
      are based on the process of ovulation stimulation, suggests that although this process was
      initially welcomed with the aim of achieving a large number of oocytes and embryos,
      consequences such as low quality of obtained oocytes and embryos, failure in achieving the
      desired results in fertility of treated patients, and the incidence of adverse effects such
      as ovarian hyper stimulation syndrome have made researchers re-examine the process of
      ovulation stimulation. Hence, mild ovulation stimulation method has been introduced to the
      field of assisted reproductive techniques (ART) in recent years. This method includes the
      prescription of low doses of gonadotropins or shorter duration of its administration in the
      ovulation stimulation cycle. Mild ovulation method has advantages such as reduction of the
      physical, mental, and financial risks of treatment which can improve the quality assisted
      reproductive services provided for infertile couples.

      Several studies have confirmed the efficiency of this method of ovulation stimulation as a
      way for improving the quality of the ovulation process and achieving desirable results in
      fertility. However, the important and interesting point in studies conducted in this area,
      particularly on IVF and ICSI cycles, is that the application of this method has been mostly
      investigated in normal populations and, after the approval of its efficiency, it has been
      recommended to be used in patients with poor or high ovarian response. It should be also
      mentioned that efficiency of this method in patients with poor ovarian response has been
      evaluated in a few studies, while in patients with high ovarian response such as those
      suffering from polycystic ovary syndrome, only few studies have been conducted in patients
      with a history of ovarian hyper stimulation syndrome. On the other hand, in many cases, the
      efficiency of mild ovulation stimulation, in which lower doses or shorter durations of
      gonadotropin administration are desired, has been investigated, and the application of
      minimal ovulation stimulation method, in which the use of clomiphene citrate is also included
      besides lower doses or shorter durations of gonadotropin administration, has been studied in
      a few cases.

      In addition to the dose and duration of gonadotropin administration, another important point
      in achieving the desired results of treatment using the ovulation stimulation cycles is the
      type of gonadotropin. The studies conducted on the comparison of recombinant-FSH (rec-FSH)
      and Human Menopausal Gonadotropin (HMG) types of gonadotropin indicate the superiority of HMG
      gonadotropins, as the results show that the administration of HMG gonadotropins will lead to
      achieving fewer but high quality oocytes and embryos. By contrast, rec-FSH application puts
      the patients at increased risk of ovarian hyper stimulation syndrome. However, the
      interesting and important point in most of these studies is that this comparison has been
      drawn in long-term treatment cycles, while few studies have been conducted on antagonist
      treatment cycles which do not fully corroborate the results obtained from long-term cycles.

      According to what mentioned above, the present research aims to study the efficiency of
      minimal ovulation stimulation method in the treatment of infertile patients with poly cystic
      ovarian syndrome (PCOS) and also the effect of gonadotropin type on treatment cycles with
      antagonist gonadotropin-releasing hormone (GnRH). It is hoped that the findings of the
      present research provide solutions for improving the quality of infertility treatment in PCOS
      patients, who currently undergo IVF or ICSI as a last resort.
    

Intervention name(s): Minimal ovarian stimulation
Intervention type(s): Other
Intervention description(s): After obtaining informed consent to participate in the study, the subjects will be randomly divided into the following 4 groups: The group of minimal ovarian stimulation with rec-FSH or HMG. The group of mild ovarian stimulation with rec-FSH or HMG. In all 4 experimental groups, after reaching at least three follicles the size of 12 millimeters (mm), daily administration of 0.25 milligram (mg) Cetrotide (antagonist GnRH) will be started and after reaching at least three follicles the size of 17 mm, 500 microgram Ovitrelle (recombinant Human curionic gonadotropin) will be prescribed. 36 hours later, ovulation process will be done. On the day of Ovitrelle administration, serum levels of estradiol and progesterone will be also evaluated. Based on the patient's condition and the quality of obtained oocytes and embryos, 2 embryos will be transferred.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment