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

Not Applicable

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: combined metformin-CC; Drug: combined N-acetyl cysteine -CC

• Registration Number: NCT01008046
• Lead Sponsor: Mansoura University

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.

Detailed 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.

Study Timeline

• Study Start: 2007-04
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2009-11
• Study First Submitted: 2009-11-04
• Study First Submitted QC: 2009-11-04
• Last Update Submitted: 2009-11-04
• Study First Posted: 2009-11-05
• Last Update Posted: 2009-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 192

Inclusion Criteria

• CC resistant PCOS

Exclusion Criteria

• Congenital adrenal hyperplasia
• Cushing syndrome
• Androgen secreting tumors

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
combined metformin-CC	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.
combined N-acetyl cysteine - CC	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

Primary Outcome Measures

Name	Time	Method
Ovulation rate

Secondary Outcome Measures

Name	Time	Method
pregnancy rate

Trial Locations

Locations (1)

Mansoura University Hospitals,OB/GYN department; 🇪🇬 Mansoura, Dakahlia Governorate, Egypt