Infertility and Pregnancy Outcomes of Fertility Spared Gynecological Oncology Patients

Not Applicable

Recruiting

• Conditions: Fertility Disorders; Gynecologic Cancer
• Interventions: Procedure: Fertility sparing surgery

• Registration Number: NCT05823194
• Lead Sponsor: Acibadem University

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.

Study Timeline

• Study Start: 2022-12-01
• Study First Submitted: 2023-03-18
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-09
• Last Update Submitted: 2023-04-09
• Study First Posted: 2023-04-21
• Last Update Posted: 2023-04-21
• Primary Completion: 2023-05-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fertility spared gynecologic cancer diagnosed women	Fertility sparing surgery	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Acibadem Maslak Hospital; 🇹🇷 Istanbul, Turkey