Serum Kisspeptin Levels in Infertile Women

Bakirkoy Dr. Sadi Konuk Training and Research Hospital

Status: Completed

Conditions: Unexplained Infertility; Anovulation; Infertility, Female

Treatments: Other: Blood sample

Study type: Observational

Funder types: Other

Identifiers

NCT03018314

2016/165

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: No Healthy Volunteers

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

Trial design

90 participants in 3 patient groups

Group 1

Description:

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

Treatment:

Other: Blood sample

Group 2

Description:

The second group will comprise of 30 women with diagnosis of unexplained infertility, normal menstrual periods and without known male factor infertility.

Treatment:

Other: Blood sample

Group 3

Description:

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%.

Treatment:

Other: Blood sample