Letrozole and Sequential Clomiphene to Improve the Outcome of Embryo Transfer

Not Applicable

• Conditions: Female Infertility Due to Nonimplantation of Ovum
• Interventions: Drug: Letrozole; Drug: clomiphene; Drug: HMG

• Registration Number: NCT02775877
• Lead Sponsor: Navy General Hospital, Beijing

Brief Summary

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

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 Timeline

• Study First Submitted: 2015-12-29
• Study Start: 2016-05
• Study First Submitted QC: 2016-05-15
• Study First Posted: 2016-05-18
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-21
• Last Update Posted: 2017-06-23
• Primary Completion: 2019-06
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
letrozole and clomiphene	Letrozole	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.
letrozole and clomiphene	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.
Letrozole and human menopausal gonadotropin (HMG)	Letrozole	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
Letrozole and human menopausal gonadotropin (HMG)	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

Primary Outcome Measures

Name	Time	Method
live birth rate	3 years	The event that a FETUS is born alive with heartbeats or RESPIRATION

Secondary Outcome Measures

Name	Time	Method
mature follic	1 month	The diameter of follic more than 18mm is the mature follic
miscarriage	3 years	Expulsion of the product of FERTILIZATION before completing the term of GESTATION and without deliberate interference.
clinical pregnancy rate	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.
multiple pregnancies	3 years	The condition of carrying two or more FETUSES.

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Navy General Hospital.; 🇨🇳 Beijing, Beijing, China