Congenital Uterine Anomalies & Pregnancy in Polycystic Ovarian Syndrome

Mullerian Anomaly of Uterus, Nec Clinical Trial

— CONUTA&PPCOS  

Official title:

Investigation of the Effect of Serum Androgen and Anti-Mullerian Hormone Levels on the Frequency of Müllerian Anomalies and Pregnancy Outcomes in Patients With Polycystic Ovarian Syndrome Undergoing Invitro Fertilization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04776915
• Other study ID #: 2020-18/17
• Status: Recruiting
• Start date: October 14, 2020
• Est. completion date: February 1, 2022

Study information

• Verified date: February 2021
• Source: Uludag University
• Contact: Gürkan Uncu, Prof.
• Phone: +902242952541
• Email: guncu[@]gurkanuncu.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Mullerian Anomaly of Uterus, Nec
• Polycystic Ovary Syndrome

Intervention

Diagnostic Test:
• Ultrasound and Hysterosalpingography
Ultrasound and Hysterosalpingography

Locations

Country	Name	City	State
Turkey	Uludag University ART Center	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Uludag University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of Mullerian Abnormality	ESHRE&ESGE uterine abnormality classification	One year