CONUTA&PPCOS: Congenital Uterine Anomalies & Pregnancy in Polycystic Ovarian Syndrome

Sponsor

Uludag University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04776915

Collaborator

(none)

100

Enrollment

Location

15.6

Anticipated Duration (Months)

6.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Mullerian Anomaly of Uterus, Nec	Diagnostic Test: Ultrasound and Hysterosalpingography

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

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

Actual Study Start Date :

Oct 14, 2020

Anticipated Primary Completion Date :

Jan 1, 2022

Anticipated Study Completion Date :

Feb 1, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Study Group

Infertile patients due to polycystic ovarian syndrome

Diagnostic Test: Ultrasound and Hysterosalpingography

Ultrasound and Hysterosalpingography

Control Group

Infertile patients due to unexplained infertility

Diagnostic Test: Ultrasound and Hysterosalpingography

Ultrasound and Hysterosalpingography

Outcome Measures

Primary Outcome Measures

The rate of Mullerian Abnormality [One year]
ESHRE&ESGE uterine abnormality classification

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Uludag University ART Center	Bursa		Turkey

Sponsors and Collaborators

Uludag University

Investigators

Principal Investigator: Özge Albayrak, M.D, Bursa Uludag University School of Medicine ART Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

GÜRKAN UNCU,PROF. MD, Prof. Dr., Uludag University

ClinicalTrials.gov Identifier:

NCT04776915

Other Study ID Numbers:

2020-18/17

First Posted:

Mar 2, 2021

Last Update Posted:

Mar 2, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by GÜRKAN UNCU,PROF. MD, Prof. Dr., Uludag University

mullerian anomaly, PCOS, antimullerian hormone

Additional relevant MeSH terms:

Polycystic Ovary Syndrome

Congenital Abnormalities

Study Results

No Results Posted as of Mar 2, 2021