NCT02127944

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

December 7, 2018

Status Verified

December 1, 2018

Enrollment Period

1.2 years

First QC Date

April 15, 2014

Last Update Submit

December 6, 2018

Conditions

InfertilityInfertility, Female

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • ULTRASONOGRAPHIC ASSESSMENT OF OVARIAN RESERVE MARKERS

    ONE DAY

Study Arms (2)

FERTILE GROUP

WOMEN HAVE NO INFERTILITY PROBLEMS AND HAVE AT LEAST ONE CHILD

UNEXPLAINED INFERTILE GROUP

WOMEN WITH INFERTILITY PROBLEMS,NO HISTORY OF PREGNANCY AND HAVE NO CHILDREN

Eligibility Criteria

Age21 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

ALL STUDY PARTICIPANTS SHOULD BE LESS THAN 35 YEARS OLD, MARRIED , SHOULD HAVE REGULAR MENSES AND SHOULD HAVE AT LEAST A YEAR OF UNPROTECTED SEX.

You may qualify if:

  • LESS THAN 35 YEARS OLD,
  • MARRIED WOMEN
  • SHOULD HAVE REGULAR MENSES
  • SHOULD HAVE AT LEAST A YEAR OF UNPROTECTED SEX.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ktu Farabi Hospital

Trabzon, 61080, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

SERUM SAMPLES OF PATIENTS WILL BE STORED .THE SERUM SAMPLES DO NOT CONTAIN DNA.

MeSH Terms

Conditions

InfertilityInfertility, Female

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy Complications

Study Officials

  • SULEYMAN GUVEN

    KARADENIZ TECHNICAL UNIVERSITY -MEDICAL FACULTY

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assıstant. Professor.

Study Record Dates

First Submitted

April 15, 2014

First Posted

May 1, 2014

Study Start

April 1, 2014

Primary Completion

June 1, 2015

Study Completion

July 1, 2015

Last Updated

December 7, 2018

Record last verified: 2018-12

Locations

TU(1)