NCT03164421

Brief Summary

N-Acetylcysteine and L-carnitine were used in pcos patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
164

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2017

Shorter than P25 for phase_2

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

January 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

September 18, 2018

Status Verified

June 1, 2017

Enrollment Period

1.4 years

First QC Date

May 21, 2017

Last Update Submit

September 16, 2018

Conditions

PCOS

Outcome Measures

Primary Outcomes (1)

  • pregnancy rate

    number of women with clinical pregnancy

    3 momths

Secondary Outcomes (2)

  • ovulation rate

    3 momths

  • abortion rate

    3 momths

Study Arms (2)

N-Acetylcysteine

EXPERIMENTAL

N-Acetylcysteine used by clomiphene resistant pcos women

Drug: N-Acetylcysteine

L-carnitine

ACTIVE COMPARATOR

L-carnitine used by clomiphene resistant pcos women

Drug: L-carnitine

Interventions

N-AcetylcysteineDRUG

N-Acetylcysteine in clomiphene resistant pcos women

N-Acetylcysteine
L-carnitineDRUG

L-carnitine in clomiphene resistant pcos women

Also known as: motova plus
L-carnitine

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • pco
  • infertile

You may not qualify if:

  • no medical disorders
  • no hormonal treatment in the previous 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zagazig University

Zagazig, Egypt

Location

Related Publications (1)

  • El Sharkwy IA, Abd El Aziz WM. Randomized controlled trial of N-acetylcysteine versus l-carnitine among women with clomiphene-citrate-resistant polycystic ovary syndrome. Int J Gynaecol Obstet. 2019 Oct;147(1):59-64. doi: 10.1002/ijgo.12902. Epub 2019 Jul 17.

    PMID: 31273783DERIVED

MeSH Terms

Interventions

AcetylcysteineCarnitine

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsTrimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAmines

Study Officials

  • ibrahim A EL sharkwy, MD

    FACULTY OF MEDICINE ,ZAGAZIG UNIVERSITY

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

May 21, 2017

First Posted

May 23, 2017

Study Start

January 1, 2017

Primary Completion

June 1, 2018

Study Completion

July 1, 2018

Last Updated

September 18, 2018

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will share

the collected data willbe available within 6 months

Locations

EG(1)