Serum Kisspeptin Levels in Infertile Women

Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03018314
Collaborator
(none)
90
1
14
6.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Blood sample

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 Design

Study Type:
Observational
Actual Enrollment :
90 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Serum Kisspeptin Levels in Infertile Women Due to Anovulatory Cycles, Unexplained Infertility or Male Subfertility: A Prospective Observational Study
Study Start Date :
Jun 1, 2016
Actual Primary Completion Date :
Jun 1, 2017
Actual Study Completion Date :
Aug 1, 2017

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. The relation of Kisspeptin levels and female infertility [1 year]

    Secondary Outcome Measures

    1. The relation of Kisspeptin levels and follicular growth [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 38 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology Istanbul Turkey 34250

    Sponsors and Collaborators

    • Bakirkoy Dr. Sadi Konuk Research and Training Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Bakirkoy Dr. Sadi Konuk Research and Training Hospital
    ClinicalTrials.gov Identifier:
    NCT03018314
    Other Study ID Numbers:
    • 2016/165
    First Posted:
    Jan 12, 2017
    Last Update Posted:
    Aug 28, 2017
    Last Verified:
    Aug 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 28, 2017