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Completed

NCT Number: NCT03018314

Serum Kisspeptin Levels in Infertile Women

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.

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Key information

Age range

18 year–38 year

Sex eligibility

Female

Study type

Observational

Primary location

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

Istanbul, 34250, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood sample

Other

Serum analysis

Other names: Serum Kisspeptin levels

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

Sponsors and collaborators

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 12, 2017
Registry last updated
Aug 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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