Effect of Chromium Supplementation on Intracytoplasmatic Sperm Injection (ICSI) Outcomes in Polycystic Ovary Syndrome Ladies
Condition: PCOS
MeSH terms: Polycystic Ovary Syndrome
Study type: Interventional

Summary: 
      This study is a prospective, double-blind, randomized controlled trial . It included 60
      infertile obese patients with polycystic ovary syndrome (PCOS), who are scheduled for
      intracytoplasmatic sperm injection (ICSI) cycle. The patients will be randomly allocated into
      two equal groups; Group (A): patients receive chromium supplementation as capsules of 200
      micrograms of chromium picolinate (Arab company for pharmaceuticals and medicinal plants),
      Group (B): no chromium supplementation. Both patients and outcome assessors are blinded to
      allocated group. All 100 participants underwent similar ICSI cycles. Primary outcome is
      clinical pregnancy rate per cycle. Secondary outcomes include Body mass index (BMI) and
      waist/hip ratio (WHR), fasting insulin , fasting plasma glucose, Homeostatic model assessment
      (HOMA) index, lipid profile ( Triglycerides (TGs), total cholesterol, High density
      Lipoprotein (HDL), Low density Lipoprotein (LDL), free and total testosterone , Sex Hormone
      Binding Globulin (SHBG), Free Androgen index (FAI), AntiMullerian Hormone (AMH), Basal
      Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH), Estradiol (E2, Days of
      stimulation , dose of gonadotrophins, number of M II oocytes retrieved, number of grade1and 2
      embryos, number of frozen embryos, freeze all cyles, Ovarian Hyperstimulation syndrome
      (OHSS), Chemical pregnancy rate, clinical pregnancy, twins and abortion.
    

Detailed description: 
      This study is a prospective, randomized controlled trial that is blinded to investigator and
      outcome assessors. Ethical committee approval is obtained. The study includes infertile obese
      patients with PCOS diagnosed according to Rotterdam criteria, who are scheduled for ICSI
      cycle. Patients with body mass index (BMI) 30-35kg/m2 are included.

      Women with diabetes, thyroid disorder or other endocrine dysfunctions, uterine abnormalities
      are excluded.

      All patients receive detailed information about the study and informed consent is given by
      those who accepted to participate in the study. Each patient is subjected to history taking
      about obstetric history, medical and surgical history and demographic distribution. Full
      physical examination and 2D transvaginal sonography (TVS) are done on day 2 to 5 of menses to
      assess antral follicle count (AFC), uterus and adnexa .

      All 100 participants are scheduled for ICSI cycles. Randomization is done by withdrawing
      closed envelopes for each patient into group A and group B . Group (A): patients receive
      chromium supplementation as capsules of 200 micrograms of chromium picolinate (Arab company
      for pharmaceuticals and medicinal plants) for 2 months, Group (B): no chromium
      supplementation.

      Antagonist protocol is followed. Gonadotropins as Intramuscular (I.M.) injections of 150-300
      (International units) I.U. of highly purified Human Menopausal Gonadotropins daily (Merional,
      75 I.U. /vial, IBSA). and Urofollitropin or highly purified human follicle stimulating
      hormone(Fostimon®, 75 I.U. /vial, IBSA) are give in a ratio of 1:1.The dose is adjusted
      according to the age, BMI, Antral follicle count (AFC), serum levels of AMH, FSH and ovarian
      response.

      On the sixth day of stimulation , a visit is scheduled to assess the ovarian response (
      folliculometry) by TVS. Gonadotrophin releasing hormone antagonist (GnRH antagonist) which is
      Cetrorelix 0.25mg ( Cetrotide®, 0.25 mg/ vial, Merck Serono, is filled and mixed with diluent
      from a prefilled syringe with a 20 gauge needle) is given subcutaneously (S.C.) by 27-gauge
      needle starting from the 6th day of stimulation (fixed antagonist protocol).

      Next visits are every other day for follow up using the TVS. The trigger by Human Chorionic
      Gonadotrophin (HCG)10000 I.U., I.M. ( Pregnyl, Organon) is given when at least 3 follicles
      reach 18mm in mean diameter or more and E2 level is less than 2500 pg/ml. Ovum retrieval is
      done 34 hours after HCG injection and embryo transfer using Wallace catheter on day 2 to 3.
      Luteal support includes natural Progesterone 400 mg 1x2 as rectal suppository, Folic acid 0.5
      mg orally once daily, Amoxicillin-Clavulanic Acid 1gm 1x2x7 orally, Progesterone 100 I.M.
      injections daily for 10 days, Acetylsalicylic Acid (75 mg) orally once daily, metformin
      500-1000 mg orally daily .

      Quantitative ß- HCG in serum after is done after 14 days of embryo transfer.TVS is performed
      to detect clinical pregnancy at 6-7 weeks of gestation.

      Primary outcome is clinical pregnancy rate per cycle. Secondary outcomes include Body mass
      index (BMI) and waist/hip ratio (WHR), fasting insulin , fasting plasma glucose, Homeostatic
      model assessment (HOMA) index, lipid profile ( Triglycerides (TGs), total cholesterol, High
      density Lipoprotein (HDL), Low density Lipoprotein (LDL), free and total testosterone , Sex
      Hormone Binding Globulin (SHBG), Free Androgen index (FAI), AntiMullerian Hormone (AMH),
      Basal Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH), Estradiol (E2, Days of
      stimulation , dose of gonadotrophins, number of M II oocytes retrieved, number of grade1and 2
      embryos, number of frozen embryos, freeze all cyles, Ovarian Hyperstimulation syndrome
      (OHSS), Chemical pregnancy rate, clinical pregnancy, twins and abortion.
    

Intervention name(s): Chromium
Intervention type(s): Dietary Supplement
Intervention description(s): chromium supplementation as capsules of 200 micrograms of chromium picolinte (Arab company for pharmaceuticals and medicinal plants) daily for 2 months before ICSI cycle
Intervention MeSH terms: Chromium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment