Infertility and Pregnancy Outcomes of Fertility Spared Gynecological Oncology Patients

NCT ID: NCT05823194

Last Updated: 2023-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2023-06-01

Brief Summary

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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

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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.

Conditions

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Fertility Disorders Gynecologic Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Fertility sparing surgery

Intervention Type PROCEDURE

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

Interventions

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Fertility sparing surgery

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Acibadem University

OTHER

Sponsor Role lead

Responsible Party

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Nazli Albayrak

PGY-4 Ob/Gyn resident, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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NAZLI ALBAYRAK, MD

Role: PRINCIPAL_INVESTIGATOR

Acibdem University

Locations

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Acibadem Maslak Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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NAZLI ALBAYRAK, MD

Role: CONTACT

00905054111626

Facility Contacts

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NAZLI ALBAYRAK, MD

Role: primary

00905054111626

References

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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.

Reference Type RESULT
PMID: 12926578 (View on PubMed)

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.

Reference Type RESULT
PMID: 31115262 (View on PubMed)

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.

Reference Type RESULT
PMID: 34769256 (View on PubMed)

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.

Reference Type RESULT
PMID: 25489139 (View on PubMed)

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.

Reference Type RESULT
PMID: 25649243 (View on PubMed)

Other Identifiers

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2022-17/10

Identifier Type: -

Identifier Source: org_study_id

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