NCT05765305

Brief Summary

Combined letrozole with chromium versus letrozole only in induction of ovulation in polycystic ovary syndrome

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2018

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

Study Start

First participant enrolled

September 1, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 13, 2023

Completed
Last Updated

March 15, 2023

Status Verified

February 1, 2023

Enrollment Period

1.1 years

First QC Date

March 1, 2023

Last Update Submit

March 13, 2023

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

  • Efficacy of letrozole

    efficacy of letrozole with chromium in improving induction of ovulation

    12 months

Secondary Outcomes (1)

  • Miscarriage rate

    12 months

Study Arms (1)

Letrozole

Letrozole versus letrozole with chromium

Drug: Letrozole with chromium

Interventions

Letrozole with chromiumDRUG

Letrozole versus letrozole with chromium

Letrozole

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Female patients aged from 18 to 35 years

You may qualify if:

  • female patients aged from 18 to 35 years Anovulatory cycles Pcos

You may not qualify if:

  • female patients aged more than 35years Male factor of infertility Other factors of infertility than pcos

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine

Cairo, القاهره, Egypt

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

LetrozoleChromium

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMetals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

March 1, 2023

First Posted

March 13, 2023

Study Start

September 1, 2018

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

March 15, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Now no plan

Locations

EG(1)