N-acetyl Cysteine for Ovulation Induction in Clomiphene Citrate Resistant Polycystic Ovary Syndrome

September 11, 2014 updated by: esraa yousef badran, Assiut University

N-acetyl Cysteine as an Adjuvant Therapy to Laparoscopic Ovarian Drilling in Clomiphene Citrate Resistant Polycystic Ovary Syndrome

Polycystic ovary syndrome is a major endocrinological disorder affecting 5-8% of reproductive aged women. Anovulation is a major feature of the syndrome, managed primarily by clomiphene citrate. Failure to respond to clomiphene citrate is termed clomiphene resistance and second line treatment is either laparoscopic ovarian drilling or gonadotrophin ovulation induction. Although laparoscopic drilling is effective in restoring ovulation and achieving pregnancy, some women still remain anovulatory and infertile after the procedure. N-acetyl cysteine has emerged as a novel therapeutic adjuvant to laparoscopic drilling to improve ovulation and pregnancy rate.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Resistance to ovulation induction therapy with clomiphene citrate (CC) is a significant problem affecting as many as 25% of patients. Laparoscopic ovarian drilling is an accepted second line treatment option, achieving ovulation in 75-90% and pregnancy in 50-69% of the CC resistant patients.

Adjuvants to laparoscopic drilling have been explored by researchers some studies have shown evidence of improved outcome with the use of N-Acetyl cystiene (NAC), a long used mucolytic drug which has been used for various other indications including detoxification and cancer chemoprotection. Several studies have addressed the possibility of using NAC as adjuvant therapy to Clomiphene citrate for induction of ovulation in resistant patients with some showing encouraging results. The use of NAC as adjuvant to laparoscopic ovarian drilling was addressed in a single pilot study showing good results with improved ovulation and pregnancy rates compared to the non users.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • PCOS patients according to Rotterdam criteria who failed to respond to 6 month ovulation induction therapy with clomiphene citrate,
  • normal semen analysis of partner
  • normal tubo-peritoneal anatomy as assessed by laparoscopy

Exclusion Criteria:

  • patients who have other causes of infertility
  • patients receiving gonadotrophin ovulation induction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: N-Acetyl cysteine
Laparoscopic ovarian drilling followed by NAC 1200mg daily in two divided doses for five days starting cycle day 2 for 6 month
Drug: N-Acetyl cysteine
Other Names:
  • NAC
  • Acetyl cysteine
Procedure: laparoscopic ovarian drilling
Active Comparator: laparoscopic drilling group
laparoscopic drilling only will be done
Procedure: laparoscopic ovarian drilling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ovulation rate
Time Frame: 6 month
ovulation will be assessed by serial transvaginal ultrasound monitoring when feasible or day 21 serum progesterone
6 month

Secondary Outcome Measures

Outcome Measure
Time Frame
pregnancy rate
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

September 4, 2014

First Submitted That Met QC Criteria

September 11, 2014

First Posted (Estimate)

September 12, 2014

Study Record Updates

Last Update Posted (Estimate)

September 12, 2014

Last Update Submitted That Met QC Criteria

September 11, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • n-acetyl cysteine PCOS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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