Serum Kisspeptin Levels in Infertile Women

August 24, 2017 updated by: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Serum Kisspeptin Levels in Infertile Women Due to Anovulatory Cycles, Unexplained Infertility or Male Subfertility: A Prospective Observational Study

The study population is comprise of 90 women those age varies between 18-38 year-old. The first group will comprise of 30 women with polycystic ovaries or anovulatory cycles, the second group will comprise of 30 women with diagnosis of unexplained infertility and the third group will comprise of 30 women those partners with male subfertility. A 2 cc blood sample for Kisspeptin analysis will be drawn from the antecubital vein from each participants. The patients will receive 50 mg clomiphene citrate at the fifth day of the menstrual period and follicular development will be measured with serial ultrasound follow up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study population is comprise of 90 women those age varies between 18-38 year-old with wish of baby for at least one year despite of unprotected sexual intercourse, patent tubes confirmed in hysterosalpingography , follicle stimulating hormone levels <12 IU. The first group will comprise of 30 women with polycystic ovaries in ultrasound examination or anovulatory cycles, the second group will comprise of 30 women with diagnosis of unexplained infertility, normal menstrual periods and without known male factor infertility and the third group will comprise of 30 women those partners with sperm count between 5x106 -15x106 /mL, type A + type B motility <%32 and Kruger morphology <4%. A 2 cc blood sample for Kisspeptin analysis will be drawn from the antecubital vein from each participants and centrifuged and sera will be kept in -80 C till recruitment has been completed. Kisspeptin, E2, Progesterone, anti-mullerian hormone levels will be measured with ELISA method. The patients will receive 50 mg clomiphene citrate at the fifth day of the menstrual period and follicular development will be measured with serial ultrasound follow up.

Study Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34250
        • Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

90 infertile female women those with infertile couples due to anovulation,male sub fertility and unexplained infertility.

Description

Inclusion Criteria:

  • ages varying between 18-38 year-old with wish of baby for at least one year despite of unprotected sexual intercourse
  • patent tubes confirmed in hysterosalpingography
  • follicle stimulating hormone levels <12 IU
  • no other relevant medical history

Exclusion Criteria:

  • ages other than 18-38 year-old with wish of baby for least than one year despite of unprotected sexual intercourse
  • obstructed tubes confirmed in hysterosalpingography
  • follicle stimulating hormone levels >12 IU
  • history thyroid disease
  • increased prolactin levels
  • history of chemo/radiation therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
The first group will comprise of 30 women with polycystic ovaries in ultrasound examination or anovulatory cycles.
Other: Blood sample
Serum analysis
Other Names:
  • Serum Kisspeptin levels
Group 2
The second group will comprise of 30 women with diagnosis of unexplained infertility, normal menstrual periods and without known male factor infertility.
Other: Blood sample
Serum analysis
Other Names:
  • Serum Kisspeptin levels
Group 3
The third group will comprise of 30 women those partners with sperm count between 5x106 -15x106 /mL, type A + type B motility <%32 and Kruger morphology <4%.
Other: Blood sample
Serum analysis
Other Names:
  • Serum Kisspeptin levels

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The relation of Kisspeptin levels and female infertility
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
The relation of Kisspeptin levels and follicular growth
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Investigators

  • Principal Investigator: Cihan Kaya, M.D., Bakırköy Dr. Sadi Konuk Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

January 10, 2017

First Submitted That Met QC Criteria

January 11, 2017

First Posted (Estimate)

January 12, 2017

Study Record Updates

Last Update Posted (Actual)

August 28, 2017

Last Update Submitted That Met QC Criteria

August 24, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/165

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After study completed

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infertility, Female

Clinical Trials on Blood sample

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Georgia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe