Serum Kisspeptin Levels in Infertile Women

NCT ID: NCT03018314

Last Updated: 2017-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-08-31

Brief Summary

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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

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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.

Conditions

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Infertility, Female Unexplained Infertility Anovulation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

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

Blood sample

Intervention Type OTHER

Serum analysis

Group 2

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

Blood sample

Intervention Type OTHER

Serum analysis

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%.

Blood sample

Intervention Type OTHER

Serum analysis

Interventions

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Blood sample

Serum analysis

Intervention Type OTHER

Other Intervention Names

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Serum Kisspeptin levels

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bakirkoy Dr. Sadi Konuk Research and Training Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cihan Kaya, M.D.

Role: PRINCIPAL_INVESTIGATOR

Bakırkoy Dr. Sadi Konuk Training and Research Hospital

Locations

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

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 24615662 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30328739 (View on PubMed)

Related Links

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Other Identifiers

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2016/165

Identifier Type: -

Identifier Source: org_study_id

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