Back to resultsLetrozole and Sequential Clomiphene to Improve the Outcome of Embryo Transfer
Primary Purpose
Female Infertility Due to Nonimplantation of Ovum
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Letrozole
clomiphene
HMG
Sponsored by
About this trial
This is an interventional treatment trial for Female Infertility Due to Nonimplantation of Ovum focused on measuring PCOS, letrozole, clomiphene
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
Sites / Locations
- Department of Obstetrics and Gynecology, Navy General Hospital.Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
letrozole and clomiphene
Letrozole and human menopausal gonadotropin (HMG)
Arm Description
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 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
Outcomes
Primary Outcome Measures
live birth rate
The event that a FETUS is born alive with heartbeats or RESPIRATION
Secondary Outcome Measures
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.
multiple pregnancies
The condition of carrying two or more FETUSES.
miscarriage
Expulsion of the product of FERTILIZATION before completing the term of GESTATION and without deliberate interference.
mature follic
The diameter of follic more than 18mm is the mature follic
Full Information
NCT ID
NCT02775877
First Posted
December 29, 2015
Last Updated
June 21, 2017
Sponsor
Navy General Hospital, Beijing
1. Study Identification
Unique Protocol Identification Number
NCT02775877
Brief Title
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
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
January 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Navy General Hospital, Beijing
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Infertility Due to Nonimplantation of Ovum
Keywords
PCOS, letrozole, clomiphene
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
letrozole and clomiphene
Arm Type
Experimental
Arm Description
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.
Arm Title
Letrozole and human menopausal gonadotropin (HMG)
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Letrozole
Intervention Type
Drug
Intervention Name(s)
clomiphene
Intervention Type
Drug
Intervention Name(s)
HMG
Primary Outcome Measure Information:
Title
live birth rate
Description
The event that a FETUS is born alive with heartbeats or RESPIRATION
Time Frame
3 years
Secondary Outcome Measure Information:
Title
clinical pregnancy rate
Description
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.
Time Frame
3 years
Title
multiple pregnancies
Description
The condition of carrying two or more FETUSES.
Time Frame
3 years
Title
miscarriage
Description
Expulsion of the product of FERTILIZATION before completing the term of GESTATION and without deliberate interference.
Time Frame
3 years
Title
mature follic
Description
The diameter of follic more than 18mm is the mature follic
Time Frame
1 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li He
Phone
17710379833
Email
qiufengyi0505@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aiming Wang, Dr
Organizational Affiliation
Navy General Hospital, Beijing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Obstetrics and Gynecology, Navy General Hospital.
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100048
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunhai Chuai, Dr
Phone
+8618810892004
Email
wangyh85@foxmail.com
First Name & Middle Initial & Last Name & Degree
Aiming Wang, Dr
Phone
+8618600310258
Email
one_army@sina.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
21693034
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.
Results Reference
background
PubMed Identifier
22265923
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.
Results Reference
background
PubMed Identifier
24348019
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. Erratum In: Drug Des Devel Ther. 2017 Apr 28;11:1367.
Results Reference
result
PubMed Identifier
25295506
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.
Results Reference
result
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Letrozole and Sequential Clomiphene to Improve the Outcome of Embryo Transfer
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