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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02127944
Other study ID # MS1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 2014
Est. completion date July 2015

Study information

Verified date December 2018
Source Karadeniz Technical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

IN UNEXPLAINED INFERTILITY IN WOMEN ,OVARY RESERVE IS BORDERLINE IF ASSESSED USING HIGH-SENSITIVE TESTS.


Description:

IN UNEXPLAINED INFERTILITY OVARIAN RESERVE TESTS WERE ASSESSED.

IN THIS STUDY, A COMPARISON IS DONE BETWEEN 35 WOMEN WITH UNEXPLAINED FERTILITY(THE PATIENT) AND 35 WOMEN WHO DON'T HAVE ANY FERTILITY PROBLEMS AND HAVE AT LEAST A CHILD (THE CONTROL GROUP).

THE STUDY PARTICIPANTS SHOULD HAVE THE FOLLOWING CRITERIA

Inclusion Criteria:

LESS THAN 35 YEARS OLD, MARRIED WOMEN SHOULD HAVE REGULAR MENSES SHOULD HAVE AT LEAST A YEAR OF UNPROTECTED SEX. THE HUSBAND'S SPERMOGRAM SHOULD HAVE NO ABNORMALITIES THE SUBJECT SHOULD HAVE A NORMAL HYSTEROSALPHINGOGRAPHY

Exclusion Criteria:

HAVING ANY SYSTEMIC DISEASE. LONG HISTORY OF ANY DRUG USAGE.

FOR THE CONTROL GROUP

Inclusion Criteria:

LESS THAN 35 YEARS OLD, MARRIED WOMEN SHOULD HAVE REGULAR MENSES AT LEAST HAVE A CHILD THE HUSBAND'S SPERMOGRAM SHOULD HAVE NO ABNORMALITIES THE SUBJECT SHOULD HAVE A NORMAL HYSTEROSALPHINGOGRAPHY

Exclusion Criteria:

HAVING ANY SYSTEMIC DISEASE. LONG HISTORY OF ANY DRUG USAGE.

THE STUDY INCLUDES THE FOLLOWING TESTS BEING DONE ON THE PATIENTS:

THE FOLLOWING HORMONES' LEVELS WERE STUDIED:AMH (ANTI-MULLERIAN HORMONE),FSH (FOLLICULAR STIMULATING HORMONE) , E2 (ESTRADIOL) AND INHIBIN B.THE FORMER THREE HORMONE LEVELS SHOULD BE ASSESSED ON THE THIRD DAY OF MENSES IN THE STUDY,TRANSVAGINAL ULTRASONOGRAPHIC OVARIAN VOLUME ,OVARIAN ANTRAL FOLLICULE NUMBER,OVARIAN STROMAL BLOODFLOW AND OVARIAN ARTERIAL RESISTANCE WAS MEASURED USING DOPPLER ULTRASONOGRAM.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date July 2015
Est. primary completion date June 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 21 Years to 35 Years
Eligibility Inclusion Criteria:

- LESS THAN 35 YEARS OLD,

- MARRIED WOMEN

- SHOULD HAVE REGULAR MENSES

- SHOULD HAVE AT LEAST A YEAR OF UNPROTECTED SEX.

Exclusion Criteria:

- HAVING ANY SYSTEMIC DISEASE.

- LONG HISTORY OF ANY DRUG USAGE.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Ktu Farabi Hospital Trabzon

Sponsors (1)

Lead Sponsor Collaborator
Karadeniz Technical University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary LEVELS OF OVARIAN RESERVE MARKERS IN THE SERUM AMH (ANTI-MULLERIAN HORMONE),FSH (FOLLICLE STIMULATING HORMONE),E2 (ESTRADIOL)AND INHIBIN -B LEVELS WILL BE TESTED ONE DAY
Secondary ULTRASONOGRAPHIC ASSESSMENT OF OVARIAN RESERVE MARKERS OVARIAN ANTRAL FOLLICULE COUNT ,OVARIAN VOLUME MEASUREMENT,OVARIAN DOPPLER -ULTRASONOGRAPHIC ASSESSMENT ONE DAY
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