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

Infertility Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00449514
• Other study ID #: tamoxi vs clomiphene.CTIL
• Status: Recruiting
• Phase: N/A
• First received: March 18, 2007
• Last updated: September 19, 2007
• Start date: May 2007

Study information

• Verified date: May 2007
• Source: Shaare Zedek Medical Center
• Contact: Avi Tsafrir, MD
• Phone: 972-508573805
• Email: avits[@]scmz.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• tamoxifen

• clomiphene citrate

Locations

Country	Name	City	State
Israel	Shaare-Zedek Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy rate
Primary	delivery rate
Secondary	endometrium thickness
Secondary	percentage of ovulation
Secondary	number of follicles