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

NCT02304107 | Completed Phase 3 DMC

• 1 other identifier: Sub 6
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• Ovulation

  Regular vaginal ultrasounds will be done starting from the 8th day of starting the drug.

  6 weeks after starting the intervention

Secondary Outcomes (1)

• Pregnancy

  6 months after starting the intervention

Study Arms (2)

FSH

ACTIVE COMPARATOR

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

Letrozole

ACTIVE COMPARATOR

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

Interventions

FSH DRUG

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

FSH

Letrozole DRUG

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.

Letrozole

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clomiphene resistant PCOS.

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

BeniSuef University hospitals

BeniSuef, Egypt

Location

Cairo University Hospitals

Cairo, Egypt

Location

Related Publications (3)

• Kar S. Clomiphene citrate or letrozole as first-line ovulation induction drug in infertile PCOS women: A prospective randomized trial. J Hum Reprod Sci. 2012 Sep;5(3):262-5. doi: 10.4103/0974-1208.106338.

  PMID: 23531705 BACKGROUND

• Vendola K, Zhou J, Wang J, Famuyiwa OA, Bievre M, Bondy CA. Androgens promote oocyte insulin-like growth factor I expression and initiation of follicle development in the primate ovary. Biol Reprod. 1999 Aug;61(2):353-7. doi: 10.1095/biolreprod61.2.353.

  PMID: 10411511 BACKGROUND

• Hassan A, Shehata N, Wahba A. Cost effectiveness of letrozole and purified urinary FSH in treating women with clomiphene citrate-resistant polycystic ovarian syndrome: a randomized controlled trial. Hum Fertil (Camb). 2017 Apr;20(1):37-42. doi: 10.1080/14647273.2016.1242783. Epub 2016 Nov 8.

  PMID: 27825272 DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Letrozole

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Gynecology and Obstetrics

Study Record Dates

• First Submitted: November 26, 2014
• First Posted: December 1, 2014
• Study Start: May 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: July 6, 2016

Record last verified: 2016-07

Locations

EG (2)