Tamoxifen Compared With Clomiphene Citrate for Women Who Had Thin Endometrium Women Under Clomiphene in a Previous Cycle
Prospective Randomized Study of Ovulation Induction Using Either Tamoxifen or Clomiphene Citrate for Women Who Had Thin Endometrium During Previous Treatment With Clomiphene Citrate
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
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participants targeted
Target at P50-P75 for not_applicable
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2007
CompletedFirst Posted
Study publicly available on registry
March 20, 2007
CompletedStudy Start
First participant enrolled
May 1, 2007
CompletedSeptember 20, 2007
May 1, 2007
March 18, 2007
September 19, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Pregnancy rate
delivery rate
Secondary Outcomes (3)
endometrium thickness
percentage of ovulation
number of follicles
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Serious adverse effects under clomiphene citrate or known sensitivity to either tamoxifen or clomiphene citrate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shaare-Zedek Medical Center
Jerusalem, Israel
Related Publications (1)
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. doi: 10.1093/humrep/deh840. Epub 2005 Apr 21.
PMID: 15845599BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Avi Tsafrir, MD
Department of Obstetrics and Gynecology, Shaare-Zedek Medical Center, Jerusalem, Israel
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 18, 2007
First Posted
March 20, 2007
Study Start
May 1, 2007
Last Updated
September 20, 2007
Record last verified: 2007-05