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Tamoxifen Compared With Clomiphene Citrate for Women Who Had Thin Endometrium Women Under Clomiphene in a Previous Cycle

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ClinicalTrials.gov Identifier: NCT00449514
Recruitment Status : Unknown
Verified May 2007 by Shaare Zedek Medical Center.
Recruitment status was:  Recruiting
First Posted : March 20, 2007
Last Update Posted : September 20, 2007
Sponsor:
Information provided by:
Shaare Zedek Medical Center

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.

Condition or disease Intervention/treatment Phase
Infertility Drug: tamoxifen Drug: clomiphene citrate Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility
U.S. FDA Resources




Primary Outcome Measures :
  1. Pregnancy rate
  2. delivery rate

Secondary Outcome Measures :
  1. endometrium thickness
  2. percentage of ovulation
  3. number of follicles


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00449514


Contacts
Contact: Avi Tsafrir, MD 972-508573805 avits@scmz.org.il

Locations
Israel
Shaare-Zedek Medical Center Recruiting
Jerusalem, Israel
Contact: Avi Tsafrir, MD    +972-508573805    avits@szmc.org.il   
Principal Investigator: Avi Tsafrir, MD         
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Principal Investigator: Avi Tsafrir, MD Department of Obstetrics and Gynecology, Shaare-Zedek Medical Center, Jerusalem, Israel

Publications:
ClinicalTrials.gov Identifier: NCT00449514     History of Changes
Other Study ID Numbers: tamoxi vs clomiphene.CTIL
First Posted: March 20, 2007    Key Record Dates
Last Update Posted: September 20, 2007
Last Verified: May 2007

Keywords provided by Shaare Zedek Medical Center:
infertility
ovulation dysfunction
endometrium
tamoxifen
clomiphene citrate

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Citric Acid
Tamoxifen
Clomiphene
Enclomiphene
Zuclomiphene
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents