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| Sponsor: | Shaare Zedek Medical Center |
|---|---|
| Information provided by: | Shaare Zedek Medical Center |
| ClinicalTrials.gov Identifier: | NCT00449514 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Infertility |
Drug: tamoxifen Drug: clomiphene citrate |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Avi Tsafrir, MD | 972-508573805 | avits@scmz.org.il |
| Israel | |
| Shaare-Zedek Medical Center | Recruiting |
| Jerusalem, Israel | |
| Contact: Avi Tsafrir, MD +972-508573805 avits@szmc.org.il | |
| Principal Investigator: Avi Tsafrir, MD | |
| Principal Investigator: | Avi Tsafrir, MD | Department of Obstetrics and Gynecology, Shaare-Zedek Medical Center, Jerusalem, Israel |
More Information
| ClinicalTrials.gov Identifier: | NCT00449514 History of Changes |
| Other Study ID Numbers: | tamoxi vs clomiphene.CTIL |
| Study First Received: | March 18, 2007 |
| Last Updated: | September 19, 2007 |
| Health Authority: | Israel: Ministry of Health |
|
infertility ovulation dysfunction endometrium tamoxifen clomiphene citrate |
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Infertility Genital Diseases, Male Genital Diseases, Female Citric Acid Clomiphene Tamoxifen Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Chelating Agents Molecular Mechanisms of Pharmacological Action |
Estrogen Antagonists Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Fertility Agents, Female Fertility Agents Reproductive Control Agents Selective Estrogen Receptor Modulators Antineoplastic Agents, Hormonal Antineoplastic Agents Bone Density Conservation Agents |