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Trial Title:
Infertility and Pregnancy Outcomes of Fertility Spared Gynecological Oncology Patients
NCT ID:
NCT05823194
Condition:
Fertility Disorders
Gynecologic Cancer
Conditions: Official terms:
Infertility
Conditions: Keywords:
fertility sparing
gynecologic malignancy
quality of life
infertility
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
The study included a comprehensive evaluation of the participants' medical history,
surgical procedures, oncological treatment, and fertility preservation methods.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Fertility sparing surgery
Description:
Sparing the uterus and/or ovaries of the patients suffering from gynecologic malignancies
to keep the patients' fertility
Arm group label:
Fertility spared gynecologic cancer diagnosed women
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.
Criteria for 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
Gender:
Female
Minimum age:
20 Years
Maximum age:
49 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Acibadem Maslak Hospital
Address:
City:
Istanbul
Zip:
34303
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
NAZLI ALBAYRAK, MD
Phone:
00905054111626
Email:
albayraknazli@gmail.com
Investigator:
Last name:
NAZLI ALBAYRAK, MD
Email:
Principal Investigator
Start date:
December 1, 2022
Completion date:
June 1, 2023
Lead sponsor:
Agency:
Acibadem University
Agency class:
Other
Source:
Acibadem University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05823194
