Infertility and Pregnancy Outcomes of Fertility Spared Gynecological Oncology Patients

NCT05823194 | Unknown

• 1 other identifier: 2022-17/10
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Fertility Disorders; Gynecologic Cancer

Keywords

fertility sparing; gynecologic malignancy; quality of life; infertility

Outcome Measures

Primary Outcomes (2)

• Incidence of pregnancy of patients received FSS

  Incidence and rate of patients getting pregnant after FSS

  In 12 years 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

  In 12 years after FSS

Secondary Outcomes (1)

• Satisfaction assesed by WHO-QoL Bref and decision-regret scale after FSS

  12 years

Study Arms (1)

Fertility spared gynecologic cancer diagnosed women

OTHER

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

Interventions

Fertility sparing surgery PROCEDURE

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

Fertility spared gynecologic cancer diagnosed women

Eligibility Criteria

• Age: 20 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of gynecologic cancer, and being fertile in the meantime
• Applying directly to gynecologic oncology department
• Demand of preserving the fertility

You may not qualify if:

• 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

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Acibadem Maslak Hospital

Istanbul, 34303, Turkey (Türkiye)

RECRUITING

Related 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.

  PMID: 12926578 RESULT

• 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.

  PMID: 31115262 RESULT

• 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.

  PMID: 34769256 RESULT

• 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.

  PMID: 25489139 RESULT

• 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.

  PMID: 25649243 RESULT

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• NAZLI ALBAYRAK, MD

  Acibdem University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

NAZLI ALBAYRAK, MD

CONTACT

00905054111626; albayraknazli@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PGY-4 Ob/Gyn resident, MD

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

Study Record Dates

• First Submitted: March 18, 2023
• First Posted: April 21, 2023
• Study Start: December 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: June 1, 2023
• Last Updated: April 21, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)