Fertility DisordersNCT05823194
Infertility and Pregnancy Outcomes of Fertility Spared Gynecological Oncology Patients
A study testing Fertility sparing surgery in people with Fertility Disorders and Gynecologic Cancer, run by Acibadem University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 20 to 49 years, women only
- Conditions the study is for
- Fertility Disorders, Gynecologic Cancer
- What is being tested?
- Fertility sparing surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2022to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of gynecologic cancer, and being fertile in the meantime
- Applying directly to gynecologic oncology department
- Demand of preserving the fertility
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Acibadem Maslak Hospital
Istanbul, 34303
NAZLI ALBAYRAK, MD, 00905054111626, albayraknazli@gmail.com
NAZLI ALBAYRAK, MD
About this study
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)
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.
Read the 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.
- Conditions
- Fertility Disorders, Gynecologic Cancer
- Being tested
- Fertility sparing surgery
- Keywords
- fertility sparing, gynecologic malignancy, quality of life, infertility
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fertility sparing surgeryProcedure or surgery
Sparing the uterus and/or ovaries of the patients suffering from gynecologic malignancies to keep the patients' fertility
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Fertility sparing surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pregnancy of patients received FSS
Incidence and rate of patients getting pregnant after FSS
Measured: 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
Measured: In 12 years after FSS
Secondary outcomes (1)
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
Measured: 12 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start1 Dec 2022
- Primary completion1 May 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Fertility DisordersStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study included a comprehensive evaluation of the participants' medical history, surgical procedures, oncological treatment, and fertility preservation methods.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazli Albayrak, Acibadem University
- Investigators
- NAZLI ALBAYRAK, MD, Principal investigator, Acibdem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823194
- Sponsor's protocol ID
- 2022-17/10
- Status last verified
- Apr 2023
- First submitted
- 18 Mar 2023
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12926578Wang 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.
PubMed 31115262Gullo 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.
PubMed 34769256Kovacs 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.
PubMed 25489139Levine 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.
PubMed 25649243
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05823194
- Acronym / sponsor ID
- 2022-17/10
- Conditions
- Fertility Disorders, Gynecologic Cancer
- Keywords
- fertility sparing, gynecologic malignancy, quality of life, infertility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 21 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study included a comprehensive evaluation of the participants' medical history, surgical procedures, oncological treatment, and fertility preservation methods.
| Arm | Type | Receives |
|---|---|---|
| Fertility spared gynecologic cancer diagnosed women | Other | Procedure: Fertility sparing surgeryParticipants 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. |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosis of gynecologic cancer, and being fertile in the meantime
- Applying directly to gynecologic oncology department
- Demand of preserving the fertility
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fertility sparing surgerySparing the uterus and/or ovaries of the patients suffering from gynecologic malignancies to keep the patients' fertility | Procedure or surgery | Fertility spared gynecologic cancer diagnosed women |
Primary outcome
Incidence of pregnancy of patients received FSS
Time frame: 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
Time frame: In 12 years after FSS
Rate of patients referring to IVF clinic after FSS
1 secondary outcome
Satisfaction assesed by WHO-QoL Bref and decision-regret scale after FSS
Time frame: 12 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Results publication: PubMed 12926578Brehaut 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.
- Results publication: PubMed 31115262Wang 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.
- Results publication: PubMed 34769256Gullo 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.
- Results publication: PubMed 25489139Kovacs 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.
- Results publication: PubMed 25649243Levine 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.
- Individual participant dataSharing planned: No
Related trials for Fertility Disorders
Active, not recruiting
Ovarian Tissue Cryopreservation in Children
Cancer
Not yet recruiting
Sperm, Exposure and Endocrine Disruptors
Fertility, Male Fertility
Recruiting
Dietary Intervention to Improve Fertility in Women With Endometriosis Undergoing IVF
Endometriosis
RecruitingObservational study
Gonadal Tissue Freezing for Fertility Preservation in Individuals at Risk for Ovarian Dysfunction, Premature Ovarian Insufficiency and Clinically Indicated Gonadectomy
Turner Syndrome, Post-menarcheal Adolescents
Active, not recruitingObservational study
Factors Influencing Fertility or Pregnancy Health
Menstrual Cycles, Conception
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
NAZLI ALBAYRAK, MD principal investigator
Acibdem University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fertility sparing surgery in people with Fertility Disorders and Gynecologic Cancer, run by Acibadem University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact NAZLI ALBAYRAK, MD (00905054111626, albayraknazli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of pregnancy of patients received FSS (time frame: In 12 years after FSS). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05823194, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.