Effect of Chromium Supplementation on Intracytoplasmatic Sperm Injection (ICSI) Outcomes in Polycystic Ovary Syndrome Ladies

PCOS Clinical Trial

Official title:

The Value of Chromium Supplementation on Cycles Characteristics of Patients With Polycystic Ovary Syndrome Undergoing Intracytoplasmic Sperm Injection (ICSI).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03503201
• Other study ID #: 1198900
• Status: Completed
• Phase: N/A
• Start date: April 23, 2018
• Est. completion date: February 21, 2019

Study information

• Verified date: March 2019
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 21, 2019
• Est. primary completion date: February 21, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• infertile obese patients with PCOS diagnosed according to Rotterdam criteria scheduled for ICSI cycle

• patients with BMI 30-35kg/m2

Exclusion Criteria:

• Women with diabetes, thyroid disorder or other endocrine dysfunctions

• Women with uterine abnormalities.

Related Conditions & MeSH terms

• PCOS
• Polycystic Ovary Syndrome

Intervention

Dietary Supplement:
• Chromium
chromium supplementation as capsules of 200 micrograms of chromium picolinte (Arab company for pharmaceuticals and medicinal plants) daily for 2 months before ICSI cycle

Locations

Country	Name	City	State
Egypt	KasrELAiniH	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical pregnancy rate per cycle	detection of gestational sac, embryonal pole and fetal pulsations by ultrasonography per cycle	14 weeks
Secondary	Body mass index	The weight in kilograms divided by the squared height in meters	8 weeks
Secondary	Concentration of fasting insulin	Insulin level in serum after fasting for 8 hours measured as mIU/ml	8 weeks
Secondary	Concentration of free testosterone	Free testosterone level in serum measured as ng/dL	8 weeks
Secondary	Number of days of stimulation with gonadotrophins	Days of stimulation with gonadotrophins	10 weeks
Secondary	Number of ampoules of gonadotrophins	total number of ampoules of gonadotrophins	10 weeks
Secondary	number of MII oocytes retrieved per cycle	number of MII oocytes retrieved per cycle	10 weeks
Secondary	fertilization rate per cycle	fertilization rate per cycle	10 weeks
Secondary	number of embryos	number of embryos	14 weeks
Secondary	grades of embryo quality	embryo quality graded as grade I,II,III,IV	11 weeks
Secondary	chemical pregnancy rate per cycle	chemical pregnancy rate per cycle	12 weeks
Secondary	twins rate per cycle	twins rate per cycle	14 weeks
Secondary	miscarriage rate per cycle	miscarriage rate per cycle	28 weeks
Secondary	Number of frozen embryos	Number of frozen embryos	10 to 11weeks
Secondary	Number of freeze all cycles	total number of freeze all cycles	10 to 11weeks
Secondary	Number of cases with Ovarian Hyperstimulation Syndrome	number of cases diagnosed with Ovarian Hyperstimulation Syndrome	12 to 14 weeks