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Clinical Trial Name - Tamoxifen Compared With Clomiphene Citrate for Women Who Had Thin Endometrium Women Under Clomiphe

 
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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