CompletedNot Applicable

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

Egypt100 participantsStarted 2018-04-23

Plain-language 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.

Who can participate

Age range

20 Years – 40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

clinical pregnancy rate per cycle

Timeframe: 14 weeks

Trial details

NCT IDNCT03503201

SponsorKasr El Aini Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-02-21

View on ClinicalTrials.gov More PCOS trials