Congenital Uterine Anomalies & Pregnancy in Polycystic Ovarian Syndrome

NCT ID: NCT04776915

Last Updated: 2021-03-02

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

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-14

Study Completion Date

2022-02-01

Brief Summary

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Prospective research in which patients who applied to UUTF Gynecology and Obstetrics ART center for the treatment of infertility (inability to conceive despite one year of unprotected sexual intercourse), who will undergo IVF due to PCOS and unexplained infertility

Detailed Description

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As of 01/10/2020, IVF cycles of patients with PCOS (n = 105) and unexplained infertility (n = 105) who have applied to Bursa Uludag University Gynecology and Obstetrics Department, Reproductive Treatments Center, will be included in the study. Demographic data of all patients (age, BMI, smoking), presence of hyperandrogenism findings such as systemic diseases, hirsutism, alopecia, FSH, LH, LH/FSH ratio, estradiol levels, pregestational serum AMH levels, uterine anomalies detected by transvaginal USG or hysterosalpingography, controlled ovarian hyperstimulation protocols and doses; Besides, DHEA-S, Free Testosterone, 17-OH Progesterone levels will be recorded in patients diagnosed with PCOS. All these data are routine laboratory and imaging parameters of patients who underwent in vitro fertilization in our UYTE center. Pregnancy results of the patients (biochemical pregnancy, anembryonic pregnancy, abortion, clinical pregnancy, live birth), perinatal results and complications during clinical pregnancy, delivery ways, and newborn APGAR scores will be recorded. Results will be compared with patients in the control group diagnosed with unexplained infertility.

Conditions

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Mullerian Anomaly of Uterus, Nec

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Study Group

Infertile patients due to polycystic ovarian syndrome

Ultrasound and Hysterosalpingography

Intervention Type DIAGNOSTIC_TEST

Ultrasound and Hysterosalpingography

Control Group

Infertile patients due to unexplained infertility

Ultrasound and Hysterosalpingography

Intervention Type DIAGNOSTIC_TEST

Ultrasound and Hysterosalpingography

Interventions

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Ultrasound and Hysterosalpingography

Ultrasound and Hysterosalpingography

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Being in the age range of 20-40
* Need for an assisted reproductive method due to PCOS or unexplained infertility

Exclusion Criteria

* \<20 years or \>40 years
* Detecting a cause for infertility other than PCOS
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Uludag University

OTHER

Sponsor Role lead

Responsible Party

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GÜRKAN UNCU,PROF. MD

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Özge Albayrak, M.D

Role: PRINCIPAL_INVESTIGATOR

Bursa Uludag University School of Medicine ART Center

Locations

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Uludag University ART Center

Bursa, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Gürkan Uncu, Prof.

Role: CONTACT

+902242952541

Kiper Aslan, M.D.

Role: CONTACT

+902242952541

Facility Contacts

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Gürkan Uncu, Prof.

Role: primary

02242952541

Other Identifiers

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2020-18/17

Identifier Type: -

Identifier Source: org_study_id

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