Letrozole and Sequential Clomiphene to Improve the Outcome of Embryo Transfer

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

Detailed Description
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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.

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

Conditions
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Female Infertility Due to Nonimplantation of Ovum

Intervention / Treatment
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* Drug: Letrozole
* Drug: clomiphene
* Drug: HMG


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: letrozole and clomiphene<br>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<br> <br> Drug: clomiphene<br> <br> |
| Active Comparator: Letrozole and human menopausal gonadotropin (HMG)<br>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<br> <br> Drug: HMG<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy rate | 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 | The condition of carrying two or more FETUSES. | 3 years | 
| miscarriage | Expulsion of the product of FERTILIZATION before completing the term of GESTATION and without deliberate interference. | 3 years | 
| mature follic | The diameter of follic more than 18mm is the mature follic | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCOS, letrozole, clomiphene