Clinical trial NCT03018314: Serum Kisspeptin Levels in Infertile Women
Official title: Serum Kisspeptin Levels in Infertile Women Due to Anovulatory Cycles, Unexplained Infertility or Male Subfertility: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility, Female
Unexplained Infertility
Anovulation
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2017-01-12
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 90 infertile female women those with infertile couples due to anovulation,male sub fertility and unexplained infertility.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The relation of Kisspeptin levels and female infertility
timeFrame: 1 year
Secondary outcomes:
measure: The relation of Kisspeptin levels and follicular growth
timeFrame: 1 year
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology
Study officials:
affiliation: Bakırkoy Dr. Sadi Konuk Training and Research Hospital
name: Cihan Kaya, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.