NCT04170439

Brief Summary

PCO is one of the factors associated with delayed conception

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

November 16, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

November 20, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2020

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2020

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

5 months

First QC Date

November 16, 2019

Last Update Submit

April 26, 2021

Conditions

PCO

Outcome Measures

Primary Outcomes (1)

  • The number of women who will have mature follicles wih their size and number of mqture follicles The number of women who will have mature follicles

    Assessment of women in both groups for size and number of follicles

    within 2 weeks

Study Arms (3)

clomiphene plus metformin plus N acetyle cysteine

OTHER

Women who will receive clomiphene citrate plus metformin plus n acetyle cysteine

Drug: Clomiphene plus metformin plus N acetyle cysteine in arm number 1

clomiphene plus metformin plus chromium

OTHER

Women who will receive clomiphene plus metformin plus chromium

Drug: Clomiphene citrate plus metformin with chromium

clomiphen citrate plus metformin

OTHER

Women who will receive clomiphene plus metformin

Drug: clomiphene citrate plus metformin

Interventions

Clomiphene plus metformin plus N acetyle cysteine in arm number 1DRUG

oral adminstration of clomiphene citrate plus metformin plus N acetyl cysteine or chromium

clomiphene plus metformin plus N acetyle cysteine
Clomiphene citrate plus metformin with chromiumDRUG

oral adminstration of clomiphene citrate plus metformin and chromium

clomiphene plus metformin plus chromium
clomiphene citrate plus metforminDRUG

oral adminstration of clomiphene citrate plus metformin

clomiphen citrate plus metformin

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen with PCO
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • women with PCO

You may not qualify if:

  • women who donot have PCO

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Algazeerah and Kasralainy hospital

Giza, Egypt

Location

Algazeerah

Giza, Egypt

Location

MeSH Terms

Interventions

ClomipheneMetforminChromium

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBiguanidesGuanidinesAmidinesMetals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • Mahmoud Alalfy, PhD

    Algezeera

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Women who will receive clomiphe citrate plus N acetyle cysteine rally in arm number 1 And women who will receive clomiphene citrate and chromoum in arm number 22
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in national research crntre and Algezzera hospital ,egypt

Study Record Dates

First Submitted

November 16, 2019

First Posted

November 20, 2019

Study Start

November 20, 2019

Primary Completion

May 2, 2020

Study Completion

May 15, 2020

Last Updated

April 28, 2021

Record last verified: 2021-04

Locations

EG(2)