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

Primary Purpose

Infertility Poly Cystic Ovary

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Letrozole

About this trial

This is an interventional treatment trial for Infertility Poly Cystic Ovary

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Step Up group

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Number of mature follicles

Secondary Outcome Measures

Pregnancy rate

Full Information

NCT ID

NCT03181919

First Posted

June 7, 2017

Last Updated

June 7, 2017

Sponsor

Benha University

1. Study Identification

Unique Protocol Identification Number

NCT03181919

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

January 1, 2016 (Actual)

Primary Completion Date

January 1, 2017 (Actual)

Study Completion Date

March 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Benha University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

Detailed Description

The current study was conducted in private outpatient clinic after being approved by the medical ethics committee. The study is a prospective randomized study consisting of 90 Egyptian patients diagnosed as having infertility with pcos . Sample size determination: Group sample sizes of 42 and 42 achieve 80% power based on study finding carried out by (Galal et al., 2014) to detect a difference of 0.7 between the null hypothesis that both group means are 2.2 and the alternative hypothesis that the mean of group 2 is 1.5 with known group standard deviations of 1.5 and 0.6 and with a significance level (alpha) of 0.05000 using a two-sided Mann-Whitney test assuming that the actual distribution is uniform. Sample size was calculated by PASS 11 Computer program for sample size calculation. Taking into consideration 10% drop out rate, the sample size will be increased to 45 patients in group I and another 45 patients in group II. Patients were divided into two groups with randomization sheet: Group (I): includes 45 females taking Letrozole (old regimen). Group (II): includes 45 females taking Letrozole 5 mg tab in a step-up protocol (new regimen).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility Poly Cystic Ovary

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Step Up group

Arm Type

Experimental

Arm Description

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.

Arm Title

Control group

Arm Type

No Intervention

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Letrozole

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of mature follicles

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

Pregnancy rate

Time Frame

one month

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Publish a manuscript

Learn more about this trial

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

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