Infertility and Pregnancy Outcomes of Fertility Spared Gynecological Oncology Patients

Sponsor

Acibadem University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05823194

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

8.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Fertility Disorders Gynecologic Cancer	Procedure: Fertility sparing surgery	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

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.The study included a comprehensive evaluation of the participants' medical history, surgical procedures, oncological treatment, and fertility preservation methods.

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Fertility spared gynecologic cancer diagnosed women 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.	Procedure: Fertility sparing surgery Sparing the uterus and/or ovaries of the patients suffering from gynecologic malignancies to keep the patients' fertility

Arm

Intervention/Treatment

Other: Fertility spared gynecologic cancer diagnosed women

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.

Procedure: Fertility sparing surgery

Sparing the uterus and/or ovaries of the patients suffering from gynecologic malignancies to keep the patients' fertility

Outcome Measures

Primary Outcome Measures

Incidence of pregnancy of patients received FSS [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 [In 12 years after FSS]
Rate of patients referring to IVF clinic after FSS

Secondary Outcome Measures

Satisfaction assesed by WHO-QoL Bref and decision-regret scale after FSS [12 years]
% of patients' satisfaction via Quality of life after the surgery, and decision-regret analysis regarding to fertility sparing by the validated questionnaires

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 49 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Acibadem Maslak Hospital	Istanbul		Turkey	34303

Sponsors and Collaborators

Acibadem University

Investigators

Principal Investigator: NAZLI ALBAYRAK, MD, Acibdem University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nazli Albayrak, PGY-4 Ob/Gyn resident, MD, Acibadem University

ClinicalTrials.gov Identifier:

NCT05823194

Other Study ID Numbers:

2022-17/10

First Posted:

Apr 21, 2023

Last Update Posted:

Apr 21, 2023

Last Verified:

Apr 1, 2023

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 Nazli Albayrak, PGY-4 Ob/Gyn resident, MD, Acibadem University

fertility sparing

gynecologic malignancy

quality of life

infertility

Additional relevant MeSH terms:

Infertility

Study Results

No Results Posted as of Apr 21, 2023