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

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ClinicalTrials.gov Identifier: NCT03241472
Recruitment Status : Completed
First Posted : August 7, 2017
Last Update Posted : August 7, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohamed Abbas, Assiut University

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Infertility Drug: Letrozole Drug: Clomiphene Citrate plus N acetyl cystine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Induction of Ovulation Using Clomiphene Citrate and N-acetyl Cysteine Versus Letrozole
Actual Study Start Date : February 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

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




Primary Outcome Measures :
  1. rate of ovulation [ Time Frame: 3 months ]
    ultrasound evaluation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

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Responsible Party: Ahmed Mohamed Abbas, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03241472     History of Changes
Other Study ID Numbers: NACLET
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: August 7, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female
Citric Acid
Sodium Citrate
Letrozole
Clomiphene
Enclomiphene
Zuclomiphene
Acetylcysteine
N-monoacetylcystine
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Antiviral Agents