Letrozole and Sequential Clomiphene to Improve the Outcome of Embryo Transfer

June 21, 2017 updated by: Yunhai Chuai, Navy General Hospital, Beijing

Letrozole and Sequential Clomiphene to Improve the Outcome of Embryo Transfer in Polycystic Ovary Syndrome (PCOS) Patients

The purpose of this study is to study the effects of letrozole and sequential clomiphene in ovulation and pregnancy in PCOS patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

To evaluate the efficacy of letrozole and clomiphene in PCOS patients is important,especially in resistent PCOS patients. Although most medications prove the effectiveness of letrozole and clomiphene,the subjects of letrozole and sequential clomiphene in PCOS patients are rarely.The trial may provide further basis for this medication in PCOS patients in ovulation. If the medication demonstrates efficacy, the method would help the patients with PCOS to deal with the problem of infertility.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100048
        • Recruiting
        • Department of Obstetrics and Gynecology, Navy General Hospital.
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 38 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women with PCOS

Exclusion Criteria:

  • •Women more than 38 years or less than 20 years

    • With infectious diseases or endocrine diseases
    • Who refuse to participate in the experiment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: letrozole and clomiphene
Letrozole 5 mg tablet orally from 3-7 day of once a day menstrual cycle and clomiphene100 mg tablet orally once a day from 11-15 day of menstrual cycle.
Drug: Letrozole
Drug: clomiphene
Active Comparator: Letrozole and human menopausal gonadotropin (HMG)
Letrozole 5 mg tablet orally from 3-7 day of once a day menstrual cycle and HMG 75u once a day by intramuscular injection from 11-15day of menstrual cycle
Drug: Letrozole
Drug: HMG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
live birth rate
Time Frame: 3 years
The event that a FETUS is born alive with heartbeats or RESPIRATION
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
miscarriage
Time Frame: 3 years
Expulsion of the product of FERTILIZATION before completing the term of GESTATION and without deliberate interference.
3 years
clinical pregnancy rate
Time Frame: 3 years
The ratio of the number of conceptions (CONCEPTION) including Live BIRTH; STILLBIRTH; and fetal losses, to the mean number of females of reproductive age in a population during a set time period.
3 years
multiple pregnancies
Time Frame: 3 years
The condition of carrying two or more FETUSES.
3 years
mature follic
Time Frame: 1 month
The diameter of follic more than 18mm is the mature follic
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Navy General Hospital, Beijing

Investigators

  • Principal Investigator: Aiming Wang, Dr, Navy General Hospital, Beijing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

June 1, 2019

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

December 29, 2015

First Submitted That Met QC Criteria

May 15, 2016

First Posted (Estimate)

May 18, 2016

Study Record Updates

Last Update Posted (Actual)

June 23, 2017

Last Update Submitted That Met QC Criteria

June 21, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HL2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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