Clinical trial NCT02775877: Letrozole and Sequential Clomiphene to Improve the Outcome of Embryo Transfer
Official title: Letrozole and Sequential Clomiphene to Improve the Outcome of Embryo Transfer in Polycystic Ovary Syndrome (PCOS) Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Female Infertility Due to Nonimplantation of Ovum
Keywords: PCOS
letrozole
clomiphene
Lead sponsor: Navy General Hospital, Beijing
Sponsor class: OTHER
First posted: 2016-05-18
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: live birth rate
timeFrame: 3 years
Secondary outcomes:
measure: clinical pregnancy rate
timeFrame: 3 years
measure: multiple pregnancies
timeFrame: 3 years
measure: miscarriage
timeFrame: 3 years
measure: mature follic
timeFrame: 1 month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Obstetrics and Gynecology, Navy General Hospital.
state: Beijing
Study officials:
affiliation: Navy General Hospital, Beijing
name: Aiming Wang, Dr
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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. No abstract available.