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

NCT ID: NCT00449514

Last Updated: 2007-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Infertility

Keywords

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infertility ovulation dysfunction endometrium tamoxifen clomiphene citrate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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tamoxifen

Intervention Type DRUG

clomiphene citrate

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shaare Zedek Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Avi Tsafrir, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Obstetrics and Gynecology, Shaare-Zedek Medical Center, Jerusalem, Israel

Locations

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Shaare-Zedek Medical Center

Jerusalem, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Avi Tsafrir, MD

Role: CONTACT

Phone: 972-508573805

Email: [email protected]

Facility Contacts

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Avi Tsafrir, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 15845599 (View on PubMed)

Other Identifiers

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tamoxi vs clomiphene.CTIL

Identifier Type: -

Identifier Source: org_study_id