InfertilityNCT02127944
Assessment of Ovarian Reserve Tests in Unexplained Infertile Women
An observational study of Infertility and Infertility, Female, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
IN UNEXPLAINED INFERTILITY IN WOMEN ,OVARY RESERVE IS BORDERLINE IF ASSESSED USING HIGH-SENSITIVE TESTS. Read more about this study
- Who is it for?
- Ages 21 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Infertility, Female
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2014to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- LESS THAN 35 YEARS OLD,
- MARRIED WOMEN
- SHOULD HAVE REGULAR MENSES
- SHOULD HAVE AT LEAST A YEAR OF UNPROTECTED SEX.
Who cannot join
- HAVING ANY SYSTEMIC DISEASE.
- LONG HISTORY OF ANY DRUG USAGE.
Trial locations and contacts
1 site in 1 country.
About this study
IN UNEXPLAINED INFERTILITY IN WOMEN ,OVARY RESERVE IS BORDERLINE IF ASSESSED USING HIGH-SENSITIVE TESTS.
Read the detailed 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.
- Conditions
- Infertility, Infertility, Female
- Medical subject headings
- Infertility, Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: ONE DAY
Secondary outcomes (1)
ULTRASONOGRAPHIC ASSESSMENT OF OVARIAN RESERVE MARKERS
OVARIAN ANTRAL FOLLICULE COUNT ,OVARIAN VOLUME MEASUREMENT,OVARIAN DOPPLER -ULTRASONOGRAPHIC ASSESSMENT
Measured: ONE DAY
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suleyman Guven, Karadeniz Technical University
- Investigators
- SULEYMAN GUVEN, Principal investigator, KARADENIZ TECHNICAL UNIVERSITY -MEDICAL FACULTY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127944
- Sponsor's protocol ID
- MS1
- Status last verified
- Dec 2018
- First submitted
- 15 Apr 2014
- Last updated
- 7 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Ovarian Reserve Tests in Unexplained Infertile Women
- ClinicalTrials.gov ID
- NCT02127944
- Acronym / sponsor ID
- MS1
- Conditions
- Infertility, Infertility, Female
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 1 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
IN UNEXPLAINED INFERTILITY IN WOMEN ,OVARY RESERVE IS BORDERLINE IF ASSESSED USING HIGH-SENSITIVE TESTS.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- LESS THAN 35 YEARS OLD,
- MARRIED WOMEN
- SHOULD HAVE REGULAR MENSES
- SHOULD HAVE AT LEAST A YEAR OF UNPROTECTED SEX.
Key exclusion criteria (2 listed)
- HAVING ANY SYSTEMIC DISEASE.
- LONG HISTORY OF ANY DRUG USAGE.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
LEVELS OF OVARIAN RESERVE MARKERS IN THE SERUM
Time frame: ONE DAY
AMH (ANTI-MULLERIAN HORMONE),FSH (FOLLICLE STIMULATING HORMONE),E2 (ESTRADIOL)AND INHIBIN -B LEVELS WILL BE TESTED
1 secondary outcome
ULTRASONOGRAPHIC ASSESSMENT OF OVARIAN RESERVE MARKERS
Time frame: ONE DAY
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SULEYMAN GUVEN principal investigator
KARADENIZ TECHNICAL UNIVERSITY -MEDICAL FACULTY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility and Infertility, Female, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LEVELS OF OVARIAN RESERVE MARKERS IN THE SERUM (time frame: ONE DAY). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2018; AzTrials last refreshed its copy on 8 Nov 2026.