Clinical Trials Logo

Clinical Trial Summary

Among the causes of ovulation disorders (group II of anovulation according to the World Health Organization classification), the dominant one is polycystic ovary syndrome (PCOS), and the remaining cases are classified as Hypothalamic-Pituitary-Ovarian Axis Dysfunction (HPOD). The exact etiology of both entities is unknown. To diagnose PCOS, the Rotterdam criteria must be met and other conditions that may cause hyperandrogenism or ovulation disorders must be excluded. PCOS is more often accompanied by other endocrine and metabolic disorders, such as obesity, dyslipidemia, hyperandrogenism, insulin resistance, diabetes, hyperprolactinemia and thyroid diseases, as well as infertility due to ovulation defect. These conditions not only significantly reduce quality of life (QoL), but also lead to an increased risk of cardiovascular disease, metabolic syndrome, adverse obstetric outcomes and an increased risk of endometrial cancer, further impairing QoL.


Clinical Trial Description

A prospective questionnaire study will be conducted regarding the quality of life among women undergoing hormonal diagnostics due to anovulation. The study will include women aged 18-45 with ovulation disorders: PCOS (arm 1) and HPOD (arm 2). The quality of life will be assessed using the self-assessment method using the SF-36 questionnaire (Short Form Health Survey). The questionnaire is intended for a subjective assessment of health status. It consists of 11 questions containing 36 statements that allow you to determine eight quality of life indicators, i.e.: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, general health, health change. The percentage score on a scale of 0-100% in each of the 8 life domains will be compared between both arms of the study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06208995
Study type Observational
Source Jagiellonian University
Contact Iwona Gawron, PhD, MD
Phone +48 12 4248551
Email iwona.gawron@uj.edu.pl
Status Recruiting
Phase
Start date July 1, 2023
Completion date December 30, 2024

See also
  Status Clinical Trial Phase
Completed NCT01653743 - Trial to Assess the Clinical Efficacy and Safety of MSJ-0011 in Inducing Ovulation in Anovulatory or Oligo-ovulatory Japanese Women Phase 3
Completed NCT00327366 - Effect of Bright Light on Sex Hormones and Ovulation in Humans N/A
Not yet recruiting NCT02551367 - Letrozole Versus Clomiphene Citrate for Ovulation Induction in Women With Poly Cystic Ovary Syndrome ( PCOS ) Phase 2
Completed NCT01923194 - Evaluation of Efficacy and Safety of Highly Purified Urofollitropin for Ovulation Induction in Chinese Females Phase 3
Completed NCT01008319 - Traditional Clomiphene Citrate Administration vs. Stair-step Approach Phase 3
Completed NCT00239603 - Efficacy Study of the OV-Watchâ„¢ Personal Fertility Monitor for Women Using Clomiphene Citrate. Phase 4
Recruiting NCT02309047 - The Cycle Disturbances, OLigomenorrhea and Amenorrhea (COLA) Study & Biobank
Completed NCT03252223 - Ovarian Response to Recombinant Follicle Stimulating Hormone in Women With PCOS Phase 4
Completed NCT00492882 - Study of Mechanisms of Anovulation in Polycystic Ovary Syndrome Phase 4
Completed NCT02335879 - Phase III Clinical Study of Domestic Recombinant Human Follitropin for Injection to Treat WHO Class II Anovulation Phase 3
Completed NCT00471523 - Treatment of Anovulatory Infertility in PCOS Patients Phase 4
Completed NCT02703649 - Administration of Single High Dose Letrozole for Ovulation Induction Phase 4
Completed NCT00213148 - Comparison of Anastrozole Verses Clomiphene Citrate in Stimulating Follicular Growth and Ovulation in Infertile Women With Ovulatory Dysfunction Phase 2
Completed NCT03018314 - Serum Kisspeptin Levels in Infertile Women N/A
Completed NCT02710981 - Sildenafil Vaginal Gel Co-treatment With Clomiphene Citrate in Infertile Women With Thin Endometrium N/A
Recruiting NCT02186782 - Concomitant CC and E2 Versus CC Alone in Ovulation Induction Phase 4
Not yet recruiting NCT00665171 - Whole Genome Analysis for the Detection of Key Genes in the Polycystic Ovary Syndrome N/A
Withdrawn NCT03155828 - Using CPAP to Improve Menstruation in Women With Polycystic Ovarian Syndrome and Obstructive Sleep Apnea
Withdrawn NCT00453219 - FHA: Characterization of Metabolic Status, Brain Circuitry, and Stress-Reactivity N/A
Completed NCT00920634 - Protocol for Drug Use Investigation of Follistim Injection (Study P06132)(COMPLETED)