| Original Study ID : tamoxi vs clomiphene.CTIL |
| NCT ID : 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 |
| 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. |
| Source : Shaare Zedek Medical Center |
| Overall Status : Recruiting |
| Start Date : May 2007 |
| Official Title : N/A |
| Phase : Interventional |
| Study Design : Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
| Enrollment : 100 |
| Verification Date : May 2007 |
| First Received Date : March 18, 2007 |
| Trial 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 |
| Gender : Female |
| Minimum Age : 18 Years |
| Maximum Age : 35 Years |
| Healthy Volunteers : No |
| Facilities |
| Facility Name : Shaare-Zedek Medical Center |
| Status : Recruiting |
| City : Jerusalem |
| Country : Israel |
| Refferances |
| PMID : 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. Epub 2005 Apr 21. |
| OutComes |
| Primary OutComes |
| Secondary OutComes |
| Measure : endometrium thickness |
| Measure : percentage of ovulation |
| Measure : number of follicles |
| Interventions |
| Type : Drug |
| Name : tamoxifen |
| Type : Drug |
| Name : clomiphene citrate |
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