Tamoxifen Compared With Clomiphene Citrate for Women Who Had Thin Endometrium Women Under Clomiphene in a Previous Cycle - Tabular View

Tracking Information

First Received Date ^ICMJE

March 18, 2007

Last Updated Date

September 19, 2007

Start Date ^ICMJE

May 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Pregnancy rate
delivery rate

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00449514 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

endometrium thickness
percentage of ovulation
number of follicles

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Tamoxifen Compared With Clomiphene Citrate for Women Who Had Thin Endometrium Women Under Clomiphene in a Previous Cycle

Official Title ^ICMJE

Prospective Randomized Study of Ovulation Induction Using Either Tamoxifen or Clomiphene Citrate for Women Who Had Thin Endometrium During Previous Treatment With Clomiphene Citrate

Brief Summary

About 10-15% of all couples attempting to conceive will not become pregnant within one year. Among those, the majority will have ovulatory dysfunction, mild male infertility or unexplained infertility. The traditional first line therapy for those couples is ovulation induction or superovulation using clomiphene citrate. Probably due to anti-estrogenic effects of this agent will, some patients will have a thin endometrium as measured by sonography at the time of ovulation. This phenomenon may be associated with a lower chance to conceive. Tamoxifen is a similar molecule that has been used to clomiphene citrate that has been shown to be equally effective to clomiphene in ovulation induction. Preliminary observations showed that tamoxifen does not cause a negative effect on the endometrium as compared with clomiphene, and may increase the chance to conceive in those patients who have a thin endometrium under clomiphene.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Infertility

Intervention ^ICMJE

Drug: tamoxifen
Drug: clomiphene citrate

Study Arms / Comparison Groups

Publications *

Steiner AZ, Terplan M, Paulson RJ. Comparison of tamoxifen and clomiphene citrate for ovulation induction: a meta-analysis. Hum Reprod. 2005 Jun;20(6):1511-5. Epub 2005 Apr 21.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

100

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Primary or secondary infertility due to:
Ovulatory dysfunction
Mild male infertility
Unexplained infertility
Endometrium < 6 mm at time of hCG during previous treatment with clomiphene citrate
Age 18-35

Exclusion Criteria:

Serious adverse effects under clomiphene citrate or known sensitivity to either tamoxifen or clomiphene citrate

Gender

Female

Ages

18 Years to 35 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Avi Tsafrir, MD

972-508573805

avits@scmz.org.il

Location Countries ^ICMJE

Israel

Administrative Information

NCT ID ^ICMJE

NCT00449514

Responsible Party

Study ID Numbers ^ICMJE

tamoxi vs clomiphene.CTIL

Study Sponsor ^ICMJE

Shaare Zedek Medical Center

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Avi Tsafrir, MD

Department of Obstetrics and Gynecology, Shaare-Zedek Medical Center, Jerusalem, Israel

Information Provided By

Shaare Zedek Medical Center

Verification Date

May 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP