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

Condition(s) targeted: Infertility

Intervention: tamoxifen (Drug); clomiphene citrate (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Shaare Zedek Medical Center

Official(s) and/or principal investigator(s):
Avi Tsafrir, MD, Principal Investigator, Affiliation: Department of Obstetrics and Gynecology, Shaare-Zedek Medical Center, Jerusalem, Israel

Overall contact:
Avi Tsafrir, MD, Phone: 972-508573805, Email: avits@scmz.org.il

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.

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

Primary outcome:

Pregnancy rate

delivery rate

Secondary outcome:

endometrium thickness

percentage of ovulation

number of follicles

Minimum age: 18 Years. Maximum age: 35 Years. Gender(s): Female.

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

Avi Tsafrir, MD, Phone: 972-508573805, Email: avits@scmz.org.il

Shaare-Zedek Medical Center, Jerusalem, Israel; Recruiting
Avi Tsafrir, MD, Phone: +972-508573805, Email: avits@szmc.org.il
Avi Tsafrir, MD, Principal Investigator

Related 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.

Starting date: May 2007
Last updated: September 19, 2007