The Value of Chromium Supplementation on Cycles Characteristics of Patients With Polycystic Ovary Syndrome Undergoing Intracytoplasmic Sperm Injection (ICSI).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- clinical pregnancy rate per cycle
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •infertile obese patients with PCOS diagnosed according to Rotterdam criteria scheduled for ICSI cycle
- •patients with BMI 30-35kg/m2
排除标准
- •Women with diabetes, thyroid disorder or other endocrine dysfunctions
- •Women with uterine abnormalities.
研究组 & 干预措施
No treatment
patients will not receive chromium supplementation before Intracytoplasmic sperm injection cycle
treatment
patients receive chromium supplementation as capsules of 200 micrograms of chromium picolinte (Arab company for pharmaceuticals and medicinal plants) for 2 months before Intracytoplasmic sperm injection cycle
干预措施: Chromium (Dietary Supplement)
结局指标
主要结局
clinical pregnancy rate per cycle
时间窗: 14 weeks
detection of gestational sac, embryonal pole and fetal pulsations by ultrasonography per cycle
次要结局
- Number of frozen embryos(10 to 11weeks)
- Body mass index(8 weeks)
- Concentration of free testosterone(8 weeks)
- Number of days of stimulation with gonadotrophins(10 weeks)
- twins rate per cycle(14 weeks)
- Concentration of fasting insulin(8 weeks)
- number of MII oocytes retrieved per cycle(10 weeks)
- fertilization rate per cycle(10 weeks)
- grades of embryo quality(11 weeks)
- Number of ampoules of gonadotrophins(10 weeks)
- number of embryos(14 weeks)
- chemical pregnancy rate per cycle(12 weeks)
- miscarriage rate per cycle(28 weeks)
- Number of freeze all cycles(10 to 11weeks)
- Number of cases with Ovarian Hyperstimulation Syndrome(12 to 14 weeks)
研究者
Amira S Dieb
Ob/Gyn Lecturer
Kasr El Aini Hospital