Infertility and Pregnancy Outcomes of Fertility Spared Gynecological Oncology Patients

Gynecologic Cancer Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05823194
• Other study ID #: 2022-17/10
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: April 2023
• Source: Acibadem University
• Contact: NAZLI ALBAYRAK, MD
• Phone: 00905054111626
• Email: albayraknazli[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Fertility Disorders
• Gynecologic Cancer
• Infertility

Intervention

Procedure:
• Fertility sparing surgery
Sparing the uterus and/or ovaries of the patients suffering from gynecologic malignancies to keep the patients' fertility

Locations

Country	Name	City	State
Turkey	Acibadem Maslak Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View 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 Ov — View 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. — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of pregnancy of patients received FSS	Incidence and rate of patients getting pregnant after FSS	In 12 years after FSS
Primary	Rate of pregnancy after FSS of patients seeking fertility by applying to IVF clinics	Rate of patients referring to IVF clinic after FSS	In 12 years after FSS
Secondary	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	12 years