Induction of Ovulation Using Clomiphene Citrate and N-acetyl Cysteine Versus Letrozole

Infertility is defined as a couple's inability to become pregnant after one year of unprotected intercourse in women 35 years old and younger, and for six months in women over age 35 years. In any given year, about 15 percent of couples in North America and Europe who are trying to conceive are infertile

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Drug: Letrozole; Drug: Clomiphene Citrate plus N acetyl cystine

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• All primary and secondary. Infertility due to anovulation

Exclusion Criteria:

• Male factor infertility, tubal factor.
• Endocrineopathy
• Hypothyrodism
• Morbid obesity
• Under weight
• Patient with previous surgery including drilling of ovary, Clomiphene Citrate resistant to ovulation.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lertozole; oral tablets 5 mg start from third day cycle for 5 days	Drug: Letrozole; oral tablets 5 mg
Active Comparator: clomiphene plus N- acetyl cystiene; clomiphene 100 mg plus N-acetyl cystiene 600 mg start from third day cycle for 5 days	Drug: Clomiphene Citrate plus N acetyl cystine; Clomiphene Citrate 100 mg oral tablets+ N acetyl cystiene 600 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of ovulation	ultrasound evaluation	3 months

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: August 3, 2017
• First Submitted That Met QC Criteria: August 3, 2017
• First Posted (Actual): August 7, 2017

Study Record Updates

• Last Update Posted (Actual): August 7, 2017
• Last Update Submitted That Met QC Criteria: August 3, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Reproductive Control Agents; Fertility Agents, Female; Fertility Agents; Selective Estrogen Receptor Modulators; Estrogen Receptor Modulators; Letrozole; Clomiphene; Enclomiphene; Zuclomiphene
• Other Study ID Numbers: NACLET

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No