NCT01008046

Brief Summary

The purpose of this study is to compare and determine the efficacy of combined N-acetyl cysteine and clomiphene citrate(CC)with combined metformin and CC in infertile women with Polycystic ovary syndrome(PCOS)not responding to treatment with Clomiphene alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2007

Typical duration 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

Study Start

First participant enrolled

April 1, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2009

Completed
Last Updated

November 5, 2009

Status Verified

November 1, 2009

Enrollment Period

2.2 years

First QC Date

November 4, 2009

Last Update Submit

November 4, 2009

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic ovary syndromeclomiphene resistancemetforminN-acetyl cysteine

Outcome Measures

Primary Outcomes (1)

  • Ovulation rate

Secondary Outcomes (1)

  • pregnancy rate

Study Arms (2)

combined N-acetyl cysteine - CC

EXPERIMENTAL

N-acetyl cysteine(1.8 g orally daily)for 5-6 weeks from the 1st day of spontaneous or induced menstruation followed by 100 mg CC for 5 days from day 3 of spontaneous or induced menstruation. With persistent anovulation,CC increased by 50 mg for the next cycle. Treatment continued for three successive cycles

Drug: combined N-acetyl cysteine -CC

combined metformin-CC

ACTIVE COMPARATOR

Patients received metformin HCl (1500 mg daily) for 5-6 weeks from the 1st day of spontaneous or induced menstruation, followed by 100 mg CC for 5 days starting from day 3 of spontaneous or induced menstruation. With persistent anovulation,CC increased by 50 mg for the next cycle. Treatment continued for three successive cycles.

Drug: combined metformin-CC

Interventions

combined N-acetyl cysteine -CCDRUG

N-acetyl cysteine(1.8 g orally daily)for 5-6 weeks from the 1st day of spontaneous or induced menstruation followed by 100 mg CC for 5 days from day 3 of spontaneous or induced menstruation. With persistent anovulation,CC increased by 50 mg for the next cycle. Treatment continued for three successive cycles

combined N-acetyl cysteine - CC
combined metformin-CCDRUG

Patients received metformin HCl (1500 mg daily) for 5-6 weeks from the 1st day of spontaneous or induced menstruation, followed by 100 mg CC for 5 days starting from day 3 of spontaneous or induced menstruation. With persistent anovulation,CC increased by 50 mg for the next cycle. Treatment continued for three successive cycles

combined metformin-CC

Eligibility Criteria

Age20 Years - 36 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • CC resistant PCOS

You may not qualify if:

  • Congenital adrenal hyperplasia
  • Cushing syndrome
  • Androgen secreting tumors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University Hospitals,OB/GYN department

Al Mansurah, Dakahlia Governorate, Egypt

Location

Related Publications (3)

  • Elnashar A, Fahmy M, Mansour A, Ibrahim K. N-acetyl cysteine vs. metformin in treatment of clomiphene citrate-resistant polycystic ovary syndrome: a prospective randomized controlled study. Fertil Steril. 2007 Aug;88(2):406-9. doi: 10.1016/j.fertnstert.2006.11.173. Epub 2007 Mar 1.

    PMID: 17335818BACKGROUND

  • Rizk AY, Bedaiwy MA, Al-Inany HG. N-acetyl-cysteine is a novel adjuvant to clomiphene citrate in clomiphene citrate-resistant patients with polycystic ovary syndrome. Fertil Steril. 2005 Feb;83(2):367-70. doi: 10.1016/j.fertnstert.2004.07.960.

    PMID: 15705376BACKGROUND

  • Siebert TI, Kruger TF, Steyn DW, Nosarka S. Is the addition of metformin efficacious in the treatment of clomiphene citrate-resistant patients with polycystic ovary syndrome? A structured literature review. Fertil Steril. 2006 Nov;86(5):1432-7. doi: 10.1016/j.fertnstert.2006.06.014. Epub 2006 Sep 27.

    PMID: 17007847BACKGROUND

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

  • Hatem Abu Hashim, MD. MRCOG

    Mansoura University Hospital

    PRINCIPAL INVESTIGATOR

  • Kamal Anwar, MD

    Mansoura University Hospital

    STUDY CHAIR

  • Rafat Abd El-Fatah, MD

    Mansoura University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 4, 2009

First Posted

November 5, 2009

Study Start

April 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

November 5, 2009

Record last verified: 2009-11

Locations

EG(1)