Letrozole and Sequential Clomiphene to Improve the Outcome of Embryo Transfer

Female Infertility Due to Nonimplantation of Ovum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02775877
• Other study ID #: HL2015
• Status: Recruiting
• Phase: N/A
• First received: December 29, 2015
• Last updated: June 21, 2017
• Start date: May 2016
• Est. completion date: January 2020

Study information

• Verified date: June 2017
• Source: Navy General Hospital, Beijing
• Contact: Li He
• Phone: 17710379833
• Email: qiufengyi0505[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2020
• Est. primary completion date: June 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 38 Years

Eligibility

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

Related Conditions & MeSH terms

• Female Infertility Due to Nonimplantation of Ovum
• Infertility
• Infertility, Female

Intervention

Drug:
• Letrozole

• clomiphene

• HMG

Locations

Country	Name	City	State
China	Department of Obstetrics and Gynecology, Navy General Hospital.	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Navy General Hospital, Beijing

Country where clinical trial is conducted

China, 

References & Publications (4)

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: 1 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	live birth rate	The event that a FETUS is born alive with heartbeats or RESPIRATION	3 years
Secondary	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
Secondary	multiple pregnancies	The condition of carrying two or more FETUSES.	3 years
Secondary	miscarriage	Expulsion of the product of FERTILIZATION before completing the term of GESTATION and without deliberate interference.	3 years
Secondary	mature follic	The diameter of follic more than 18mm is the mature follic	1 month