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Ovarian NeoplasmsNCT06777147

Reproductive Health Outcomes Among Young Women With Ovarian Neoplasms Following Surgery

An observational study of Ovarian Neoplasms and Reproductive System Neoplasm, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This retrospective study aims to assess reproductive health outcomes including menstrual function, fertility potential, menopausal symptoms, sexual function, and quality of life in young women following surgical treatment for ovarian neoplasms. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
How many people
120 participants
Where
No sites listed yet
Study dates
20 Oct 2026to 1 May 2028
Phase
Observational
Are there results?
Not yet: the study is under way

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 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Study population: Women aged 18 to 45 years with ovarian neoplasms who underwent surgical treatment at Women's Health Hospital, Assiut University.

Who may be able to join

  • Women aged 18 to 45 years at the time of diagnosis and surgery
  • At least 3 months after surgical treatment
  • Written informed consent

Who cannot join

  • Refusal to participate
  • Natural menopause before surgery
  • Patients treated with chemotherapy only without surgery
  • Severe psychiatric illness

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Raed A Selim contact

0201010608466

raed.16266374@med.aun.edu.eg

About this study

Official title: Reproductive Health Outcomes Among Young Women With Ovarian Neoplasms Following Surgical Treatment: A Retrospective Study

This retrospective study aims to assess reproductive health outcomes including menstrual function, fertility potential, menopausal symptoms, sexual function, and quality of life in young women following surgical treatment for ovarian neoplasms.

Read the detailed description

Ovarian neoplasms in young women can significantly impact reproductive health due to the disease itself and surgical treatment. Fertility-sparing surgery is often considered, but outcomes regarding menstrual function, sexual health, and quality of life need evaluation.

This retrospective observational study will review medical records and administer validated questionnaires to women aged 18 to 45 years who underwent surgical treatment for ovarian neoplasms at Women's Health Hospital, Assiut University.

Keywords
Ovarian neoplasms, Assiut, Reproductive health, Menstrual function, Fertility potential, Menopausal symptoms, Sexual function, Quality of life, EORTC QLQ-C30
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06777147
Study groupRoleWhat they receive
Young Women with Ovarian NeoplasmsWomen aged 18 to 45 years who underwent surgical treatment for ovarian neoplasms.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Female Sexual Function Index score

    Mean Female Sexual Function Index (FSFI) total score (range 2 to 36, higher scores indicate better sexual function).

    Measured: Baseline

Secondary outcomes (4)

  1. Reproductive Concerns After Cancer Scale score

    Mean Reproductive Concerns After Cancer (RCAC) total score (higher scores indicate greater reproductive concerns).

    Measured: Baseline

  2. Menopause Rating Scale score

    Mean Menopause Rating Scale (MRS) total score (range 0 to 44, higher scores indicate more severe menopausal symptoms).

    Measured: Baseline

  3. EORTC QLQ-C30 global health status score

    Mean EORTC QLQ-C30 global health status / quality of life score (range 0 to 100, higher scores indicate better quality of life).

    Measured: Baseline

  4. Frequency of menstrual irregularities

    Percentage of women reporting menstrual irregularities after surgery.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2025
  2. Study start20 Oct 2026 (estimated)
  3. Primary completion25 Oct 2027 (estimated)
  4. Study completion1 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06777147
Sponsor's protocol ID
Ovarian-Neoplasms-Reproductive
Status last verified
Oct 2026
First submitted
22 Dec 2024
Last updated
16 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bhopal RS, Bansal N, Steiner M, Brewster DH; Scottish Health and Ethnicity Linkage Study. Does the 'Scottish effect' apply to all ethnic groups? All-cancer, lung, colorectal, breast and prostate cancer in the Scottish Health and Ethnicity Linkage Cohort Study. BMJ Open. 2012 Sep 25;2(5):e001957. doi: 10.1136/bmjopen-2012-001957. Print 2012.

    PubMed 23012329

  • Derlatka P, Sienko J, Grabowska-Derlatka L, Palczewski P, Danska-Bidzinska A, Bidzinski M, Czajkowski K. Results of optimal debulking surgery with bowel resection in patients with advanced ovarian cancer. World J Surg Oncol. 2016 Feb 29;14:58. doi: 10.1186/s12957-016-0800-1.

    PubMed 26923029

  • Chi DS, Eisenhauer EL, Lang J, Huh J, Haddad L, Abu-Rustum NR, Sonoda Y, Levine DA, Hensley M, Barakat RR. What is the optimal goal of primary cytoreductive surgery for bulky stage IIIC epithelial ovarian carcinoma (EOC)? Gynecol Oncol. 2006 Nov;103(2):559-64. doi: 10.1016/j.ygyno.2006.03.051. Epub 2006 May 22.

    PubMed 16714056

  • van de Laar R, IntHout J, Van Gorp T, Verdonschot S, van Altena AM, Gerestein CG, Massuger LF, Zusterzeel PL, Kruitwagen RF. External validation of three prognostic models for overall survival in patients with advanced-stage epithelial ovarian cancer. Br J Cancer. 2014 Jan 7;110(1):42-8. doi: 10.1038/bjc.2013.717. Epub 2013 Nov 19.

    PubMed 24253502

  • Patankar S, Burke WM, Hou JY, Tergas AI, Huang Y, Ananth CV, Neugut AI, Hershman DL, Wright JD. Risk stratification and outcomes of women undergoing surgery for ovarian cancer. Gynecol Oncol. 2015 Jul;138(1):62-9. doi: 10.1016/j.ygyno.2015.04.037. Epub 2015 May 11.

    PubMed 25976399

  • Chiva L, Lapuente F, Castellanos T, Alonso S, Gonzalez-Martin A. What Should We Expect After a Complete Cytoreduction at the Time of Interval or Primary Debulking Surgery in Advanced Ovarian Cancer? Ann Surg Oncol. 2016 May;23(5):1666-73. doi: 10.1245/s10434-015-5051-9. Epub 2015 Dec 29.

    PubMed 26714955

  • Rutten MJ, Boldingh JH, Schuit E, Trum H, van Driel W, Mol BW, Kenter GG, Buist MR. Development and internal validation of a prognostic model for survival after debulking surgery for epithelial ovarian cancer. Gynecol Oncol. 2014 Oct;135(1):13-8. doi: 10.1016/j.ygyno.2014.07.099. Epub 2014 Aug 2.

    PubMed 25093289

Questions about this trial

What is this clinical trial studying?

An observational study of Ovarian Neoplasms and Reproductive System Neoplasm, run by Assiut University.

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 4 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: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Raed A Selim (0201010608466, raed.16266374@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Female Sexual Function Index score (time frame: Baseline). 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 NCT06777147, which also lists 7 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 16 Oct 2026.

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