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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by Shaare Zedek Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT00449514
First received: March 18, 2007
Last updated: September 19, 2007
Last verified: May 2007
History of Changes
  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

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:
  • Pregnancy rate
  • delivery rate

Secondary Outcome Measures:
  • endometrium thickness
  • percentage of ovulation
  • number of follicles

Estimated Enrollment: 100
Study Start Date: May 2007
  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

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

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
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

ClinicalTrials.gov processed this record on June 17, 2013