Skip to main content
Clinical Trials/NCT05823194
NCT05823194
Recruiting
Not Applicable

The Evaluation of Infertility and Pregnancy Outcomes, as Well as the Assessment of Quality of Life Using WHOQoL and FertiQoL, in Cases of Gynecological Malignancies That Have Undergone Fertility-sparing Surgery(FSS)

Acibadem University1 site in 1 country50 target enrollmentDecember 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fertility Disorders
Sponsor
Acibadem University
Enrollment
50
Locations
1
Primary Endpoint
Incidence of pregnancy of patients received FSS
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

FSS which aims to preserve a woman's fertility while still effectively treating the cancer, has become an increasingly popular option for young women diagnosed with these types of cancers. It is important to assess how FSS affects a woman's reproductive health, sexual function, psychological well-being, and overall quality of life. This research aims to provide valuable insights into the long-term effects of FSS on a woman's life, and can help healthcare providers make informed decisions about the best treatment options for their patients.

Detailed Description

This is a prospective cohort study that aims to evaluate the infertility and pregnancy outcomes, as well as the quality of life of women who underwent fertility-sparing surgery for gynecological malignancies. The study included a comprehensive evaluation of the participants' medical history, surgical procedures, oncological treatment, and fertility preservation methods. Participants recruited from a tertiary care hospital, and women diagnosed with gynecological malignancies (e.g. cervical, ovarian, endometrial cancer) who underwent fertility-sparing surgery between 2010 and 2022. Women who have undergone total hysterectomy, bilateral salpingo-oophorectomy, or adjuvant oncological treatment were excluded from the study. Participants were contacted by phone and asked to complete questionnaires to assess their quality of life using the WHOQoL-BREF and FertiQoL scales.

Registry
clinicaltrials.gov
Start Date
December 1, 2022
End Date
June 1, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
Acibadem University
Responsible Party
Principal Investigator
Principal Investigator

Nazli Albayrak

PGY-4 Ob/Gyn resident, MD

Acibadem University

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of gynecologic cancer, and being fertile in the meantime
  • Applying directly to gynecologic oncology department
  • Demand of preserving the fertility

Exclusion Criteria

  • Having hysterectomy prior to the diagnosis
  • Having bilateral ooferectomy prior to the diagnosis
  • Being in menopause
  • Not accepting to fill the survey
  • High stage disease which is not able to have FSS

Outcomes

Primary Outcomes

Incidence of pregnancy of patients received FSS

Time Frame: In 12 years after FSS

Incidence and rate of patients getting pregnant after FSS

Rate of pregnancy after FSS of patients seeking fertility by applying to IVF clinics

Time Frame: In 12 years after FSS

Rate of patients referring to IVF clinic after FSS

Secondary Outcomes

  • Satisfaction assesed by WHO-QoL Bref and decision-regret scale after FSS(12 years)

Study Sites (1)

Loading locations...

Similar Trials