NCT03018314

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2016

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

June 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

August 28, 2017

Status Verified

August 1, 2017

Enrollment Period

1 year

First QC Date

January 10, 2017

Last Update Submit

August 24, 2017

Conditions

Infertility, FemaleUnexplained InfertilityAnovulation

Outcome Measures

Primary Outcomes (1)

  • The relation of Kisspeptin levels and female infertility

    1 year

Secondary Outcomes (1)

  • The relation of Kisspeptin levels and follicular growth

    1 year

Study Arms (3)

Group 1

The first group will comprise of 30 women with polycystic ovaries in ultrasound examination or anovulatory cycles.

Other: Blood sample

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

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

Interventions

Blood sampleOTHER

Serum analysis

Also known as: Serum Kisspeptin levels
Group 1Group 2Group 3

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology

Istanbul, 34250, Turkey (Türkiye)

Location

Related Publications (2)

  • Skorupskaite K, George JT, Anderson RA. The kisspeptin-GnRH pathway in human reproductive health and disease. Hum Reprod Update. 2014 Jul-Aug;20(4):485-500. doi: 10.1093/humupd/dmu009. Epub 2014 Mar 9.

    PMID: 24615662BACKGROUND

  • Kaya C, Alay I, Babayeva G, Gedikbasi A, Ertas Kaya S, Ekin M, Yasar L. Serum Kisspeptin levels in unexplained infertility, polycystic ovary syndrome, and male factor infertility. Gynecol Endocrinol. 2019 Mar;35(3):228-232. doi: 10.1080/09513590.2018.1519792. Epub 2018 Oct 17.

    PMID: 30328739DERIVED

Related Links

MeSH Terms

Conditions

Infertility, FemaleAnovulation

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertilityOvarian DiseasesAdnexal DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Cihan Kaya, M.D.

    Bakırkoy Dr. Sadi Konuk Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2017

First Posted

January 12, 2017

Study Start

June 1, 2016

Primary Completion

June 1, 2017

Study Completion

August 1, 2017

Last Updated

August 28, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will share

After study completed

Locations

TU(1)