Letrozole Step-up Protocol for Ovulation Induction in Infertile Women With PCOS

NCT03181919 | Completed DMC

• 1 other identifier: letrozole step-up protocol
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

the aim of the study is to compare between the step-up and conventional protocols in ovulation induction in infertile women with PCOS

Conditions

Infertility Poly Cystic Ovary

Outcome Measures

Primary Outcomes (1)

• Number of mature follicles

  2 weeks

Secondary Outcomes (1)

• Pregnancy rate

  one month

Study Arms (2)

Step Up group

EXPERIMENTAL

includes females taking Letrozole 5 mg tablets in a step-up protocol 5 mg in day one, 7.5 in day 2, 10 mg in days 3, 12.5 mg in day 4 and 15 in day 5 started in day 3 to day 7 of menstrual cycle.

Drug: Letrozole

Control group

NO INTERVENTION

includes females taking Letrozole 5 mg tab orally once daily started in day 3 to day 7 of menstrual cycle.

Interventions

Letrozole DRUG

Letrozole is a third generation inhibitor that is emerging as a new oral agent for induction of ovulation.

Step Up group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 20 -37 years old.
• No conception for at least one year.
• Diagnosis of PCO as established by Rotterdam criteria, endometriosis diagnosed by laparoscope or unexplained infertility.

You may not qualify if:

• Age \< 20 and \> 35 years old.
• Uterine pathology e.g. fibroid or ovarian cyst.
• Hyperprolactinemia, hypo or hyperthyroidism.
• Impaired hepatic or renal function.
• History of hypersensitivity to study drugs.

Sponsors & Collaborators

• Benha University: lead

MeSH Terms

Interventions

Letrozole

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of obstetric and gynecology Benha University

Study Record Dates

• First Submitted: June 7, 2017
• First Posted: June 9, 2017
• Study Start: January 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: March 1, 2017
• Last Updated: June 9, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share