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Congenital Uterine Anomalies & Pregnancy in Polycystic Ovarian Syndrome (CONUTA&PPCOS)

B

Bursa Uludag University

Status

Unknown

Conditions

Mullerian Anomaly of Uterus, Nec

Treatments

Diagnostic Test: Ultrasound and Hysterosalpingography

Study type

Observational

Funder types

Other

Identifiers

NCT04776915
2020-18/17

Details and patient eligibility

About

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

Full description

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.

Enrollment

100 estimated patients

Sex

Female

Ages

20 to 40 years old

Volunteers

No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Study Group
Description:
Infertile patients due to polycystic ovarian syndrome
Treatment:
Diagnostic Test: Ultrasound and Hysterosalpingography
Control Group
Description:
Infertile patients due to unexplained infertility
Treatment:
Diagnostic Test: Ultrasound and Hysterosalpingography

Trial contacts and locations

1

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Central trial contact

Gürkan Uncu, Prof.; Kiper Aslan, M.D.

Data sourced from clinicaltrials.gov

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