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

Primary Purpose

Infertility

Status

Unknown status

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

tamoxifen

clomiphene citrate

About this trial

This is an interventional treatment trial for Infertility focused on measuring infertility, ovulation dysfunction, endometrium, tamoxifen, clomiphene citrate

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Shaare-Zedek Medical CenterRecruiting

Outcomes

Primary Outcome Measures

Pregnancy rate

delivery rate

Secondary Outcome Measures

endometrium thickness

percentage of ovulation

number of follicles

Full Information

NCT ID

NCT00449514

First Posted

March 18, 2007

Last Updated

September 19, 2007

Sponsor

Shaare Zedek Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00449514

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2007

Overall Recruitment Status

Unknown status

Study Start Date

May 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Shaare Zedek Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility

Keywords

infertility, ovulation dysfunction, endometrium, tamoxifen, clomiphene citrate

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

tamoxifen

Intervention Type

Drug

Intervention Name(s)

clomiphene citrate

Primary Outcome Measure Information:

Title

Pregnancy rate

Title

delivery rate

Secondary Outcome Measure Information:

Title

endometrium thickness

Title

percentage of ovulation

Title

number of follicles

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Avi Tsafrir, MD

Phone

972-508573805

avits@scmz.org.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Avi Tsafrir, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shaare-Zedek Medical Center

City

Jerusalem

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Avi Tsafrir, MD

Phone

+972-508573805

avits@szmc.org.il

First Name & Middle Initial & Last Name & Degree

Avi Tsafrir, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

15845599

Citation

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. doi: 10.1093/humrep/deh840. Epub 2005 Apr 21.

Results Reference

background

Learn more about this trial

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

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