Serum Kisspeptin Levels in Infertile Women

Infertility, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03018314
• Other study ID #: 2016/165
• Status: Completed
• Phase: N/A
• First received: January 10, 2017
• Last updated: August 24, 2017
• Start date: June 2016
• Est. completion date: August 2017

Study information

• Verified date: August 2017
• Source: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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

Related Conditions & MeSH terms

• Anovulation
• Infertility
• Infertility, Female
• Unexplained Infertility

Intervention

Other:
• Blood sample
Serum analysis

Locations

Country	Name	City	State
Turkey	Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The relation of Kisspeptin levels and female infertility		1 year
Secondary	The relation of Kisspeptin levels and follicular growth		1 year

External Links

•   PUBMED