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...
Date First Received: March 18, 2007
Last Updated: September 19, 2007
Verified by: Shaare Zedek Medical Center, May 2007
Clinical Trial Phase: N/A | Start Date: May 2007
Overall Status: Recruiting
Estimated Enrollment: 100
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: tamoxifen
- Drug: clomiphene citrate
Outcome Measures for this Clinical Trial
Primary Measures
- Pregnancy rate
- delivery rate
Secondary Measures
- endometrium thickness
- percentage of ovulation
- number of follicles
Criteria for Participation in this Clinical Trial
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 Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 35 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Shaare Zedek Medical Center
Overall Clinical Trial Officials and Contacts
Avi Tsafrir, MD Principal Investigator Department of Obstetrics and Gynecology, Shaare-Zedek Medical Center, Jerusalem, Israel
Overall Contact: Avi Tsafrir, MD 972-508573805 avits@scmz.org.il
Related Publications
References
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.
Additional Information
Information obtained from ClinicalTrials.gov on November 20, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00449514
Study ID Number: tamoxi vs clomiphene.CTIL
ClinicalTrials.gov Identifier: NCT00449514
Health Authority: Israel: Ministry of Health
Clinical Trials Authorship and Review
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