Letrozole and Sequential Clomiphene to Improve the Outcome of Embryo Transfer

NCT ID: NCT02775877

Last Updated: 2017-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2020-01-31

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.

Conditions

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Female Infertility Due to Nonimplantation of Ovum

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Letrozole

Intervention Type DRUG

clomiphene

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Letrozole

Intervention Type DRUG

HMG

Intervention Type DRUG

Interventions

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Letrozole

Intervention Type DRUG

clomiphene

Intervention Type DRUG

HMG

Intervention Type DRUG

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Navy General Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Yunhai Chuai

Department of Obstetrics and Gynecology, Navy General Hospital, Beijing

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aiming Wang, Dr

Role: PRINCIPAL_INVESTIGATOR

Navy General Hospital, Beijing

Locations

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Department of Obstetrics and Gynecology, Navy General Hospital.

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Li He

Role: CONTACT

17710379833

Facility Contacts

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Yunhai Chuai, Dr

Role: primary

+8618810892004

Aiming Wang, Dr

Role: backup

+8618600310258

References

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Kamath MS, George K. Letrozole or clomiphene citrate as first line for anovulatory infertility: a debate. Reprod Biol Endocrinol. 2011 Jun 21;9:86. doi: 10.1186/1477-7827-9-86.

Reference Type BACKGROUND
PMID: 21693034 (View on PubMed)

Legro RS, Kunselman AR, Brzyski RG, Casson PR, Diamond MP, Schlaff WD, Christman GM, Coutifaris C, Taylor HS, Eisenberg E, Santoro N, Zhang H; NICHD Reproductive Medicine Network. The Pregnancy in Polycystic Ovary Syndrome II (PPCOS II) trial: rationale and design of a double-blind randomized trial of clomiphene citrate and letrozole for the treatment of infertility in women with polycystic ovary syndrome. Contemp Clin Trials. 2012 May;33(3):470-81. doi: 10.1016/j.cct.2011.12.005. Epub 2012 Jan 13.

Reference Type BACKGROUND
PMID: 22265923 (View on PubMed)

Hajishafiha M, Dehghan M, Kiarang N, Sadegh-Asadi N, Shayegh SN, Ghasemi-Rad M. Combined letrozole and clomiphene versus letrozole and clomiphene alone in infertile patients with polycystic ovary syndrome. Drug Des Devel Ther. 2013 Dec 3;7:1427-31. doi: 10.2147/DDDT.S50972. eCollection 2013.

Reference Type RESULT
PMID: 24348019 (View on PubMed)

Legro RS, Zhang H; Eunice Kennedy Shriver NICHD Reproductive Medicine Network. Letrozole or clomiphene for infertility in the polycystic ovary syndrome. N Engl J Med. 2014 Oct 9;371(15):1463-4. doi: 10.1056/NEJMc1409550. No abstract available.

Reference Type RESULT
PMID: 25295506 (View on PubMed)

Other Identifiers

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HL2015

Identifier Type: -

Identifier Source: org_study_id

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