NCT03503201

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 19, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

April 23, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2019

Completed
Last Updated

March 29, 2019

Status Verified

March 1, 2019

Enrollment Period

10 months

First QC Date

April 2, 2018

Last Update Submit

March 27, 2019

Conditions

PCOS

Outcome Measures

Primary Outcomes (1)

  • clinical pregnancy rate per cycle

    detection of gestational sac, embryonal pole and fetal pulsations by ultrasonography per cycle

    14 weeks

Secondary Outcomes (15)

  • Body mass index

    8 weeks

  • Concentration of fasting insulin

    8 weeks

  • Concentration of free testosterone

    8 weeks

  • Number of days of stimulation with gonadotrophins

    10 weeks

  • Number of ampoules of gonadotrophins

    10 weeks

  • +10 more secondary outcomes

Study Arms (2)

treatment

ACTIVE COMPARATOR

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

Dietary Supplement: Chromium

No treatment

NO INTERVENTION

patients will not receive chromium supplementation before Intracytoplasmic sperm injection cycle

Interventions

ChromiumDIETARY_SUPPLEMENT

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

treatment

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • infertile obese patients with PCOS diagnosed according to Rotterdam criteria scheduled for ICSI cycle
  • patients with BMI 30-35kg/m2

You may not qualify if:

  • Women with diabetes, thyroid disorder or other endocrine dysfunctions
  • Women with uterine abnormalities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KasrELAiniH

Cairo, Egypt

Location

MeSH Terms

Interventions

Chromium

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • Amira S Dieb, MD

    KasrAlainiH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ob/Gyn Lecturer

Study Record Dates

First Submitted

April 2, 2018

First Posted

April 19, 2018

Study Start

April 23, 2018

Primary Completion

February 21, 2019

Study Completion

February 21, 2019

Last Updated

March 29, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)