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CompletedNCT03018314Updated Aug 28, 2017

Serum Kisspeptin Levels in Infertile Women

An observational study in Infertility, Female, Unexplained Infertility and Anovulation, sponsored by Bakirkoy Dr. Sadi Konuk Research and Training Hospital. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 38 Years. Per ClinicalTrials.gov, last updated 2017-08-28.

Sponsored by Bakirkoy Dr. Sadi Konuk Research and Training Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
90
Ages
18 Years to 38 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Infertility, Female
  • Unexplained Infertility
  • Anovulation
03

Who can participate

Ages eligible
18 Years to 38 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
90 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherBlood sample

    Serum analysis

    Also known as: Serum Kisspeptin levels

05

What researchers measure

Primary outcomes

  1. The relation of Kisspeptin levels and female infertility

    Time frame: 1 year

Secondary outcomes

  1. The relation of Kisspeptin levels and follicular growth

    Time frame: 1 year

06

Study locations

1 site
  • Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology
    Istanbul, 34250, Turkey
07

References and documents

Publications

  • 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. PubMed 24615662 ↗
  • 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. PubMed 30328739 ↗

Related links

Individual participant data

Plan to share: Yes — After study completed

08

Registry details

Key details

Study ID
NCT03018314
Lead sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Responsible party
Sponsor
First posted
Jan 12, 2017
Start date
Jun 2016
Primary completion
Jun 2017
Completion
Aug 2017
Last update
Aug 28, 2017

Study contacts

Cihan Kaya, M.D.
principal investigator · Bakırkoy Dr. Sadi Konuk Training and Research Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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