N-acetyl Cysteine and Clomiphene Citrate or Metformin and Clomiphene Citrate for Women With CC Resistant Polycystic Ovary Syndrome (PCOS).

Polycystic Ovary Syndrome Clinical Trial

Official title:

N-acetyl Cysteine Plus Clomiphene Citrate Versus Metformin and Clomiphene Citrate in Treatment of Clomiphene-resistant Polycystic Ovary Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01008046
• Other study ID #: MU- 183
• Secondary ID: FMH-112-M
• Status: Completed
• Phase: N/A
• First received: November 4, 2009
• Last updated: November 4, 2009
• Start date: April 2007
• Est. completion date: June 2009

Study information

• Verified date: November 2009
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

In combined NAC-CC group group,patients received NAC (200 mg per sachet, SEDICO, Egypt) for 5-6 weeks from the 1st day of of spontaneous or induced menstruation (in a dose of 1.8 g orally in three divided doses, 3 sachets per dose). All patients in other group received metformin HCl (Cidophage®; Chemical Industries Development, Egypt), 500 mg thrice daily for 5-6 weeks from the 1st day of spontaneous or induced menstruation. Then after the end of this period, patients in either group received 100 mg CC (Clomid®; Global Napi Pharmaceuticals,Cairo, Egypt) for 5 days starting from day 3 of spontaneous or induced menstruation. With persistent anovulation, it was increased by 50 mg for the next cycle. Patients continued treatment for three successive cycles using the same protocol. NAC and metformin were stopped only when pregnancy was documented.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 36 Years

Eligibility

Inclusion Criteria:

• CC resistant PCOS

Exclusion Criteria:

• Congenital adrenal hyperplasia

• Cushing syndrome

• Androgen secreting tumors

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• combined N-acetyl cysteine -CC
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 metformin-CC
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

Locations

Country	Name	City	State
Egypt	Mansoura University Hospitals,OB/GYN department	Mansoura	Dakahlia Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

References & 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. Epub 2007 Mar 1. — View Citation

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. — View Citation

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. Epub 2006 Sep 27. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ovulation rate			No
Secondary	pregnancy rate			No