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Comparison Between Letrozole and Urinary Purified FSH in Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome. (FSH)

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ClinicalTrials.gov Identifier: NCT02304107
Recruitment Status : Completed
First Posted : December 1, 2014
Last Update Posted : July 6, 2016
Sponsor:
Information provided by (Responsible Party):
AbdelGany Hassan, Cairo University

Brief Summary:
210 women with clomiphene resistant PCOS will be randomly divided into 3 equal groups using computer generated random numbers. Group 1 will receive FSH, group 2 will have Letrozole and group 3 will act as the control group with no intervention.

Condition or disease Intervention/treatment Phase
Infertility Drug: FSH Drug: Letrozole Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Between Letrozole and Urinary Purified FSH in Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome: A Randomised Controlled Trial
Study Start Date : May 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: FSH
70 women will receive urinary purified FSH (Fostimon® IBSA, Switzerland) 75IU daily for 7 days starting from the 3rd day of menstruation or progesterone withdrawal bleeding. If the follicle does not exceed 9 mm the dose will be increased by 37.5 IU every 7 days.
Drug: FSH
75IU daily for 7 days starting from the 3rd day of menstruation or progesterone withdrawal bleeding. If the follicle does not exceed 9mm the dose will be increased by 37.5IU every 7 days

Active Comparator: Letrozole
70 women will receive Letrozole (Femara®, Novartis, Switzerland) 2.5mg twice daily for 5 days starting from the 3rd day of menstruation or progesterone withdrawal bleeding.
Drug: Letrozole
70 women will receive Letrozole (Femara®, Novartis, Switzerland) 2.5mg twice daily for 5 days starting from the 3rd day of menstruation or progesterone withdrawal bleeding.




Primary Outcome Measures :
  1. Ovulation [ Time Frame: 6 weeks after starting the intervention ]
    Regular vaginal ultrasounds will be done starting from the 8th day of starting the drug.


Secondary Outcome Measures :
  1. Pregnancy [ Time Frame: 6 months after starting the intervention ]


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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clomiphene resistant PCOS.

Exclusion Criteria:

  • Other causes of infertility.
  • Hyperprolactinaemia.
  • Allergy to Letrozole or FSH.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02304107


Locations
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Egypt
BeniSuef University hospitals
BeniSuef, Egypt
Cairo University Hospitals
Cairo, Egypt
Sponsors and Collaborators
Cairo University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AbdelGany Hassan, Lecturer of Gynecology and Obstetrics, Cairo University
ClinicalTrials.gov Identifier: NCT02304107     History of Changes
Other Study ID Numbers: Sub 6
First Posted: December 1, 2014    Key Record Dates
Last Update Posted: July 6, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
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Infertility
Polycystic Ovary Syndrome
Genital Diseases, Male
Genital Diseases, Female
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Citric Acid
Progesterone
Letrozole
Clomiphene
Enclomiphene
Zuclomiphene
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors