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Infertility and Pregnancy Outcomes of Fertility Spared Gynecological Oncology Patients

Primary Purpose

Fertility Disorders, Gynecologic Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Fertility sparing surgery
Sponsored by
Acibadem University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fertility Disorders focused on measuring fertility sparing, gynecologic malignancy, quality of life, infertility

Eligibility Criteria

20 Years - 49 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Acibadem Maslak HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Fertility spared gynecologic cancer diagnosed women

Arm Description

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.

Outcomes

Primary Outcome Measures

Incidence of pregnancy of patients received FSS
Incidence and rate of patients getting pregnant after FSS
Rate of pregnancy after FSS of patients seeking fertility by applying to IVF clinics
Rate of patients referring to IVF clinic after FSS

Secondary Outcome Measures

Satisfaction assesed by WHO-QoL Bref and decision-regret scale after FSS
% of patients' satisfaction via Quality of life after the surgery, and decision-regret analysis regarding to fertility sparing by the validated questionnaires

Full Information

First Posted
March 18, 2023
Last Updated
April 9, 2023
Sponsor
Acibadem University
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1. Study Identification

Unique Protocol Identification Number
NCT05823194
Brief Title
Infertility and Pregnancy Outcomes of Fertility Spared Gynecological Oncology Patients
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Acibadem University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fertility Disorders, Gynecologic Cancer
Keywords
fertility sparing, gynecologic malignancy, quality of life, infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The study included a comprehensive evaluation of the participants' medical history, surgical procedures, oncological treatment, and fertility preservation methods.
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fertility spared gynecologic cancer diagnosed women
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Fertility sparing surgery
Intervention Description
Sparing the uterus and/or ovaries of the patients suffering from gynecologic malignancies to keep the patients' fertility
Primary Outcome Measure Information:
Title
Incidence of pregnancy of patients received FSS
Description
Incidence and rate of patients getting pregnant after FSS
Time Frame
In 12 years after FSS
Title
Rate of pregnancy after FSS of patients seeking fertility by applying to IVF clinics
Description
Rate of patients referring to IVF clinic after FSS
Time Frame
In 12 years after FSS
Secondary Outcome Measure Information:
Title
Satisfaction assesed by WHO-QoL Bref and decision-regret scale after FSS
Description
% of patients' satisfaction via Quality of life after the surgery, and decision-regret analysis regarding to fertility sparing by the validated questionnaires
Time Frame
12 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
NAZLI ALBAYRAK, MD
Phone
00905054111626
Email
albayraknazli@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
NAZLI ALBAYRAK, MD
Organizational Affiliation
Acibdem University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Acibadem Maslak Hospital
City
Istanbul
ZIP/Postal Code
34303
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
NAZLI ALBAYRAK, MD
Phone
00905054111626
Email
albayraknazli@gmail.com
First Name & Middle Initial & Last Name & Degree
NAZLI ALBAYRAK, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12926578
Citation
Brehaut JC, O'Connor AM, Wood TJ, Hack TF, Siminoff L, Gordon E, Feldman-Stewart D. Validation of a decision regret scale. Med Decis Making. 2003 Jul-Aug;23(4):281-92. doi: 10.1177/0272989X03256005.
Results Reference
result
PubMed Identifier
31115262
Citation
Wang A, Cui G, Jin C, Wang Y, Tian X. Multicenter research on tumor and pregnancy outcomes in patients with early-stage cervical cancer after fertility-sparing surgery. J Int Med Res. 2019 Jul;47(7):2881-2889. doi: 10.1177/0300060519845974. Epub 2019 May 22.
Results Reference
result
PubMed Identifier
34769256
Citation
Gullo G, Etrusco A, Cucinella G, Perino A, Chiantera V, Lagana AS, Tomaiuolo R, Vitagliano A, Giampaolino P, Noventa M, Andrisani A, Buzzaccarini G. Fertility-Sparing Approach in Women Affected by Stage I and Low-Grade Endometrial Carcinoma: An Updated Overview. Int J Mol Sci. 2021 Oct 31;22(21):11825. doi: 10.3390/ijms222111825.
Results Reference
result
PubMed Identifier
25489139
Citation
Kovacs P. Fertility preservation in reproductive age women with cancer. J Obstet Gynaecol India. 2014 Dec;64(6):381-7. doi: 10.1007/s13224-014-0626-0. Epub 2014 Oct 30.
Results Reference
result
PubMed Identifier
25649243
Citation
Levine JM, Kelvin JF, Quinn GP, Gracia CR. Infertility in reproductive-age female cancer survivors. Cancer. 2015 May 15;121(10):1532-9. doi: 10.1002/cncr.29181. Epub 2015 Feb 3.
Results Reference
result

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Infertility and Pregnancy Outcomes of Fertility Spared Gynecological Oncology Patients

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