Colorectal (Colon or Rectal) CancerUOT WPXRTNCT07419490
Utero-ovarian Transposition in Patients With Pelvic Malignancies Undergoing Whole Pelvic Radiotherapy
A study testing Uteroovarian transposition in people with Colorectal (Colon or Rectal) Cancer and Pelvic Malignancies, run by University of South Florida at 1 site in United States.
Trial summary
This study is designed as a Phase I clinical trial enrolling female patients aged 18-40 years who have been diagnosed with pelvic malignancies requiring whole pelvic external radiation therapy (WPXRT) and who express interest in preserving fertility and ovarian function. Read more about this study
- Who is it for?
- Ages 18 to 40 months, women only
- Conditions the study is for
- Colorectal (Colon or Rectal) Cancer, Pelvic Malignancies, Oncofertility
- What is being tested?
- Uteroovarian transposition
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to Jun 2031
- Phase
- Interventional
- 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 40 months
- Women only
- No healthy volunteers
- Child
Who may be able to join
- Age: Women 18 - 40 years of age who wish to preserve their fertility.
- Malignancy: Diagnosis of pelvic malignancies that require radiotherapy, including:
- Colon and rectal cancer with tumors.
- Anal cancer.
- Other pelvic malignancies that require administration of WPXRT.
- Desire for Fertility Preservation: The patient expresses a clear desire to preserve fertility and the ability to carry a pregnancy in the future.
Show all 14Show fewer
- Preoperative Ovarian Function: The patient must have normal ovarian function, demonstrated by specific hormonal values, including:
- Follicle-Stimulating Hormone (FSH): <10 IU/L
- Luteinizing Hormone (LH): within normal reference range for reproductive age (typically 1.5-8 IU/L in the early follicular phase).
- Anti-Müllerian Hormone (AMH): >1 ng/mL
- Estradiol (E2): within the normal range for the follicular phase (usually 30-120 pg/mL).
- No Distant Metastasis: Absence of metastatic disease confirmed by imaging (CT, MRI, or PET scans).
- Body Mass Index (BMI) < 35.
- Signed Informed Consent.
Who cannot join
- Advanced Cancer Stage: Patients with locally advanced or metastatic disease.
- Significant Uterine Pathology: Presence of large uterine fibroids, adenomyosis, or other intrauterine pathologies that would complicate the procedure or future pregnancy.
- Poor General Health or Comorbidities: Severe medical conditions that contraindicate surgical intervention, that include but not limited to:
- Cardiovascular Disease:
- Recent (within 6 months) myocardial infarction (MI).
- Ejection fraction (EF): EF <30%.
Show all 35Show fewer
- Uncontrolled hypertension: Systolic BP >180 mmHg or Diastolic BP >110 mmHg prior to surgery.
- Severe aortic stenosis: Valve area <1 cm² with symptomatic status.
- Uncontrolled Diabetes Mellitus:
- Hemoglobin A1c (HbA1c) > 9%
- Persistent fasting glucose >250 mg/dL preoperatively despite optimization.
- Severe Respiratory Diseases:
- Forced expiratory volume (FEV1): <50%.
- Oxygen saturation: Resting SpO₂ <88% on room air without supplemental oxygen.
- CO2 retention: PaCO₂ >50 mmHg.
- Connective Tissue Disorders:
- Severe systemic lupus erythematosus (SLE): Active lupus nephritis with GFR <30 mL/min.
- Scleroderma with severe pulmonary hypertension or FVC <50% predicted.
- Rheumatoid arthritis with severe cervical spine instability (atlantoaxial subluxation).
- Severe Inflammatory Bowel Disease (IBD):
- Severe Crohn's or ulcerative colitis flares with C-reactive protein (CRP) >10 mg/L and hypoalbuminemia (Albumin <2.5 g/dL).
- Severe malnutrition: BMI <18.5 kg/m² or Prealbumin <10 mg/dL
- Steroid dependency:
- Chronic steroid use (>20 mg prednisone daily) with no feasible taper pre-surgery.
- Prior Pelvic Radiotherapy.
- Prior history of systemic chemotherapy and immunotherapy that resulted in significant toxicity and residual deficit.
- Pregnancy: Patients who are currently pregnant are excluded from consideration for uterine transposition.
- Unsuitable for Ovarian Function Preservation: Women with signs of poor ovarian reserve, including:
- FSH: >10 IU/L
- AMH: <1 ng/mL
- Estradiol: outside normal range.
- Non-Candidate for Fertility: Patients with contraindications to future pregnancy, such as severe uterine abnormalities or significant risk for pregnancy-related complications.
- Body Mass Index (BMI) ≥35.
- Absence of One of the Gonadal Vessels.
- Other unlisted conditions or diagnoses that, in the opinion of the primary investigator, render the patient an unsuitable candidate for uteroovarian transposition.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Tampa General Hospital
Tampa, Florida, 33606
Jennifer Childress, RN, CCRP, 813-844-1053, jchildress@tgh.org
Vaagn Andikyan, MD, 813-844-4554, andikyan@usf.edu
About this study
Official title: A Phase I Assessment of Utero-ovarian Transposition (UOT) for Fertility Preservation in Patients With Pelvic Malignancies Undergoing Whole Pelvic Radiotherapy (WPXRT)
This study is designed as a Phase I clinical trial enrolling female patients aged 18-40 years who have been diagnosed with pelvic malignancies requiring whole pelvic external radiation therapy (WPXRT) and who express interest in preserving fertility and ovarian function.
The trial's primary objective is to assess the feasibility and safety of uterine and ovarian transposition (UOT). Premenopausal women under the age of 40 will undergo UOT using a novel minimally invasive approach.
Read more
Feasibility and safety will be evaluated through standardized postoperative assessments, including:
(A) success in mobilizing and repositioning the uterus, ovaries, and fallopian tubes while maintaining vascular integrity; (B) documentation of surgical complications; (C) monitoring the timeliness and adherence to planned WPXRT.
To enhance safety and optimize outcomes, intraoperative imaging with indocyanine green fluorescence and Doppler ultrasonography will be employed.
Short-term success will be defined by technical success in repositioning the uterus and ovaries with preserved vascular integrity, absence of major surgical complications, and timely initiation and completion of WPXRT.
Long-term success will be evaluated by the preservation of fertility.
The study's primary objective is also to evaluate surgical, reproductive, and quality-of-life outcomes following UOT. This objective will determine the procedure's efficacy in preserving ovarian and menstrual function and its potential to support future pregnancies.
Endpoints include:
(A) maintenance of normal premenopausal levels of FSH, LH, AMH, and estradiol at defined postoperative intervals; (B) assessment of menstrual timing, regularity, and characteristics to document return of ovulatory cycles; (C) evaluation of uterine integrity and reproductive potential using pelvic ultrasonography; (D) comprehensive evaluation of patient quality of life encompassing physical, emotional, sexual, and reproductive well-being.
These measures will inform optimization of surgical techniques and provide a foundation for scaling the procedure to a broader population in future studies.
Read the detailed description
This is a phase I study aimed to evaluate feasibility and safety of utero-ovarian transposition (UOT) in young women undergoing whole pelvic radiation therapy (WPXRT) for treatment of a colorectal or other cancers localized to the pelvis. By comprehensively evaluating real-world outcomes for women undergoing this procedure, the proposed work will lay the groundwork necessary to establish UOT as a viable option for fertility preservation and survivorship for this unique patient population. Rigorous inclusion and exclusion criteria will ensure the selection of appropriate candidates, who will undergo a minimally invasive transposition of their cervix, uterus, tube and ovaries outside the planned radiation fields, thus sparing transposed organs from radiation exposure. Following a brief recovery, the radiation oncology team will proceed with WPXRT to treat each patient's cancer. If chemotherapy is indicated, it will be completed at this time, prior to the second procedure. After completing radiation therapy and/or chemotherapy, the uterus and adnexa will be surgically returned to their normal anatomical position.
This study will assess surgical outcomes for enrolled subjects undergoing this care plan, assess quality of life and the preservation of fertility and uterine receptivity by multiple objective measures.
Throughout the study, patients will be closely monitored for perioperative outcomes, including surgical complications, hospital stay, and quality of life. Patterns of menstruation, as well as levels of key hormones routinely used to assess fertility (FSH, LH, AMH, and estradiol) will be measured at key time points.
Successful UOT will be defined as the ability to complete the procedure and successfully restore a viable uterus and adnexa capable of supporting normal menstruation and fertility post-radiation therapy.
The resumption of menstrual cycles for six months following the procedure will be evaluated. Quality of life will be evaluated at multiple steps as women undergo the proposed procedures as well as throughout the planned 6 months follow up window.
Data generated by this pilot study will provide critical insights into the feasibility, safety, and potential benefits of UOT as a fertility-preserving and ovarian function-conserving option for patients with pelvic malignancies undergoing WPXRT. Moving forward, data from this study will be used not only to build out the programmatic and clinical infrastructure needed to further evaluate the efficacy of UOT, but also to overcome roadblocks to its successful clinical implementation in the future.
- Being tested
- Uteroovarian transposition
- Keywords
- uterine transposition, utero-ovarian transposition, oncofertility, pelvic radiation, pelvic malignancies, rectal cancer, colorectal malignancies, fertility preservation
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uteroovarian transpositionProcedure or surgery
Also called uterine transposition
Uteroovarian transposition involves temporarily relocating the uterus, both ovaries and fallopian tubes outside the planned radiation field. Once WPXRT is complete, a second surgery is performed to return these organs to their natural position in the patient's pelvis.
| Study group | Role | What they receive |
|---|---|---|
| Uteroovarian transposition arm | Experimental | Our study population includes premenopausal women 18-40 years old who are diagnosed with pelvic malignancies, such as rectal, colorectal cancer, and other pelvic malignancies that require radiotherapy and wish to preserve fertility and ovarian function. Subjects will be interested in improving their quality of life and reproductive outcomes without the need to undergo additional reproductive endocrinology interventions. Eligible patients will undergo UOT using a novel minimally invasive approach. Receives: Procedure: Uteroovarian transposition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of uterine transposition
Success of uterine transposition (feasibility) will be defined as the percentage of cases in which the uterus, ovaries, and fallopian tubes are successfully mobilized and repositioned as planned without the need for intraoperative conversion.
Unit of Measure: Percentage of participants (%) Time Frame: up 30 days postsurgery.
Measured: From enrollment to completion of surveillance/monitoring at 52 weeks
Secondary outcomes (8)
Postoperative Complications
Postoperative complications will be monitored. All complications will be graded according to the Clavien-Dindo classification system.
Unit of Measure: Number of participants with complications.
Measured: From enrollment to 4 weeks postsurgery
Menstrual Function
Menstrual function will be evaluated by assessing the return of menses, cycle regularity, and ovulatory characteristics through a standardized postoperative questionnaire.
Unit of Measure:
Percentage of participants (%)
Measured: From enrollment then at 4, 8, 12 weeks and 52 weeks after surgery
Hormonal Function: Follicle-Stimulating Hormone (FSH)
Hormonal Function will be evaluated by measuring serum levels of FSH
Unit of Measure:
Hormone concentration: IU/L
Measured: From enrollment then at 4, 8, 12 weeks and 52 weeks after surgery
Hormonal Function: Luteinizing Hormone (LH)
Hormonal Function will be evaluated by measuring serum levels of LH.
Unit of Measure:
Hormone concentration: IU/L.
Measured: From enrollment then at 4, 8, 12 weeks and 52 weeks after surgery
Hormonal Function: Anti-Mullerian Hormone (AMH)
Hormonal Function will be evaluated by measuring serum levels of AMH.
Unit of Measure:
Hormone concentration: IU/L.
Measured: From enrollment then at 4, 8, 12 weeks and 52 weeks after surgery
Hormonal Function: Estradiol
Hormonal Function will be evaluated by measuring serum levels of estradiol.
Unit of Measure:
Hormone concentration: ng/mL.
Measured: From enrollment then at 4, 8, 12 weeks and 52 weeks after surgery
Quality of Life: FSFI survey
Quality of life will be measured using the FSFI survey.
Unit of Measure:
FSFI total score.
Measured: At enrollment then at 12 weeks and 52 weeks after surgery
Quality of Life: EORTC QLC-C30
Quality of life will be measured using the EORTC QLQ-C30.
Unit of Measure:
EORTC QLQ-C30 score.
Measured: At enrollment then at 12 weeks and 52 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start1 Apr 2026
- Primary completionJun 2030 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colorectal (Colon or Rectal) CancerStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe 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
- This is a phase I study evaluating feasibility and safety of utero-ovarian transposition (UOT) in young women undergoing whole pelvic radiation therapy (WPXRT) for treatment of rectal or other cancers localized to the pelvis. Rigorous inclusion and exclusion criteria will ensure the selection of appropriate candidates, who will undergo a minimally invasive transposition of their cervix, uterus, tube and ovaries outside the planned radiation fields. Following a brief recovery, the radiation oncology team will proceed with WPXRT to treat each patient's cancer. After completing radiation therapy and systemic chemotherapy, the uterus and adnexa will be surgically returned to their normal anatomical position. Throughout the study, patients will be closely monitored for perioperative outcomes, including surgical complications, hospital stay, reproductive metrics and quality of life.
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vaagn Andikyan, University of South Florida
- Investigators
- Vaagn Andikyan, Principal investigator, USF Health Morsani College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419490
- Sponsor's protocol ID
- STUDY008615
- Acronym
- UOT WPXRT
- Status last verified
- Nov 2025
- First submitted
- 24 Nov 2025
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon reasonable request, deidentified clinical data generated during the study will be available from the principal investigator, Dr. Vaagn Andikyan.
Publications
Apelian S, Vest A, Yasukawa M, Wellcome J, Kohut A, Imudia AN, Tuli R, Anderson ML, Rutherford T, Andikyan V. Uterine Transposition for Fertility Preservation and Ovarian Conservation in Patients Undergoing Pelvic Radiotherapy. Obstet Gynecol. 2025 Nov 1;146(5):679-689. doi: 10.1097/AOG.0000000000005954. Epub 2025 Jul 3.
PubMed 40609092Ribeiro R, Baiocchi G, Moretti-Marques R, Linhares JC, Costa CN, Pareja R. Uterine transposition for fertility and ovarian function preservation after radiotherapy. Int J Gynecol Cancer. 2023 Dec 4;33(12):1837-1842. doi: 10.1136/ijgc-2023-004723.
PubMed 37898483Ribeiro R, Rebolho JC, Tsumanuma FK, Brandalize GG, Trippia CH, Saab KA. Uterine transposition: technique and a case report. Fertil Steril. 2017 Aug;108(2):320-324.e1. doi: 10.1016/j.fertnstert.2017.06.016. Epub 2017 Jul 8.
PubMed 28697913
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Assessment of Utero-ovarian Transposition (UOT) for Fertility Preservation in Patients With Pelvic Malignancies Undergoing Whole Pelvic Radiotherapy (WPXRT)
- ClinicalTrials.gov ID
- NCT07419490
- Acronym / sponsor ID
- UOT WPXRT / STUDY008615
- Keywords
- uterine transposition, utero-ovarian transposition, oncofertility, pelvic radiation, pelvic malignancies, rectal cancer, colorectal malignancies, fertility preservation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 19 Feb 2026 (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.
This study is designed as a Phase I clinical trial enrolling female patients aged 18-40 years who have been diagnosed with pelvic malignancies requiring whole pelvic external radiation therapy (WPXRT) and who express interest in preserving fertility and ovarian function.
The trial's primary objective is to assess the feasibility and safety of uterine and ovarian transposition (UOT). Premenopausal women under the age of 40 will undergo UOT using a novel minimally invasive approach.
Feasibility and safety will be evaluated through standardized postoperative assessments, including:
(A) success in mobilizing and repositioning the uterus, ovaries, and fallopian tubes while maintaining vascular integrity; (B) documentation of surgical complications; (C) monitoring the timeliness and adherence to planned WPXRT.
To enhance safety and optimize outcomes, intraoperative imaging with indocyanine green fluorescence and Doppler ultrasonography will be employed.
Short-term success will be defined by technical success in repositioning the uterus and ovaries with preserved vascular integrity, absence of major surgical complications, and timely initiation and completion of WPXRT.
Long-term success will be evaluated by the preservation of fertility.
The study's primary objective is also to evaluate surgical, reproductive, and quality-of-life outcomes following UOT. This objective will determine the procedure's efficacy in preserving ovarian and menstrual function and its potential to support future pregnancies.
Endpoints include:
(A) maintenance of normal premenopausal levels of FSH, LH, AMH, and estradiol at defined postoperative intervals; (B) assessment of menstrual timing, regularity, and characteristics to document return of ovulatory cycles; (C) evaluation of uterine integrity and reproductive potential using pelvic ultrasonography; (D) comprehensive evaluation of patient quality of life encompassing physical, emotional, sexual, and reproductive well-being.
These measures will inform optimization of surgical techniques and provide a foundation for scaling the procedure to a broader population in future studies.
Detailed description
This is a phase I study aimed to evaluate feasibility and safety of utero-ovarian transposition (UOT) in young women undergoing whole pelvic radiation therapy (WPXRT) for treatment of a colorectal or other cancers localized to the pelvis. By comprehensively evaluating real-world outcomes for women undergoing this procedure, the proposed work will lay the groundwork necessary to establish UOT as a viable option for fertility preservation and survivorship for this unique patient population. Rigorous inclusion and exclusion criteria will ensure the selection of appropriate candidates, who will undergo a minimally invasive transposition of their cervix, uterus, tube and ovaries outside the planned radiation fields, thus sparing transposed organs from radiation exposure. Following a brief recovery, the radiation oncology team will proceed with WPXRT to treat each patient's cancer. If chemotherapy is indicated, it will be completed at this time, prior to the second procedure. After completing radiation therapy and/or chemotherapy, the uterus and adnexa will be surgically returned to their normal anatomical position.
This study will assess surgical outcomes for enrolled subjects undergoing this care plan, assess quality of life and the preservation of fertility and uterine receptivity by multiple objective measures.
Throughout the study, patients will be closely monitored for perioperative outcomes, including surgical complications, hospital stay, and quality of life. Patterns of menstruation, as well as levels of key hormones routinely used to assess fertility (FSH, LH, AMH, and estradiol) will be measured at key time points.
Successful UOT will be defined as the ability to complete the procedure and successfully restore a viable uterus and adnexa capable of supporting normal menstruation and fertility post-radiation therapy.
The resumption of menstrual cycles for six months following the procedure will be evaluated. Quality of life will be evaluated at multiple steps as women undergo the proposed procedures as well as throughout the planned 6 months follow up window.
Data generated by this pilot study will provide critical insights into the feasibility, safety, and potential benefits of UOT as a fertility-preserving and ovarian function-conserving option for patients with pelvic malignancies undergoing WPXRT. Moving forward, data from this study will be used not only to build out the programmatic and clinical infrastructure needed to further evaluate the efficacy of UOT, but also to overcome roadblocks to its successful clinical implementation in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a phase I study evaluating feasibility and safety of utero-ovarian transposition (UOT) in young women undergoing whole pelvic radiation therapy (WPXRT) for treatment of rectal or other cancers localized to the pelvis. Rigorous inclusion and exclusion criteria will ensure the selection of appropriate candidates, who will undergo a minimally invasive transposition of their cervix, uterus, tube and ovaries outside the planned radiation fields. Following a brief recovery, the radiation oncology team will proceed with WPXRT to treat each patient's cancer. After completing radiation therapy and systemic chemotherapy, the uterus and adnexa will be surgically returned to their normal anatomical position. Throughout the study, patients will be closely monitored for perioperative outcomes, including surgical complications, hospital stay, reproductive metrics and quality of life.
| Arm | Type | Receives |
|---|---|---|
| Uteroovarian transposition arm | Experimental | Procedure: Uteroovarian transpositionOur study population includes premenopausal women 18-40 years old who are diagnosed with pelvic malignancies, such as rectal, colorectal cancer, and other pelvic malignancies that require radiotherapy and wish to preserve fertility and ovarian function. Subjects will be interested in improving their quality of life and reproductive outcomes without the need to undergo additional reproductive endocrinology interventions. Eligible patients will undergo UOT using a novel minimally invasive approach. |
Who may qualify
- Ages
- 18 to 40 months
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- Age: Women 18 - 40 years of age who wish to preserve their fertility.
- Malignancy: Diagnosis of pelvic malignancies that require radiotherapy, including:
- Desire for Fertility Preservation: The patient expresses a clear desire to preserve fertility and the ability to carry a pregnancy in the future.
- Preoperative Ovarian Function: The patient must have normal ovarian function, demonstrated by specific hormonal values, including:
- No Distant Metastasis: Absence of metastatic disease confirmed by imaging (CT, MRI, or PET scans).
Key exclusion criteria (35 listed)
- Advanced Cancer Stage: Patients with locally advanced or metastatic disease.
- Significant Uterine Pathology: Presence of large uterine fibroids, adenomyosis, or other intrauterine pathologies that would complicate the procedure or future pregnancy.
- Poor General Health or Comorbidities: Severe medical conditions that contraindicate surgical intervention, that include but not limited to:
- Prior Pelvic Radiotherapy.
- Prior history of systemic chemotherapy and immunotherapy that resulted in significant toxicity and residual deficit.
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 |
|---|---|---|
| Uteroovarian transpositionAlso: uterine transpositionUteroovarian transposition involves temporarily relocating the uterus, both ovaries and fallopian tubes outside the planned radiation field. Once WPXRT is complete, a second surgery is performed to return these organs to their natural position in the patient's pelvis. | Procedure or surgery | Uteroovarian transposition arm |
Primary outcome
Success of uterine transposition
Time frame: From enrollment to completion of surveillance/monitoring at 52 weeks
Success of uterine transposition (feasibility) will be defined as the percentage of cases in which the uterus, ovaries, and fallopian tubes are successfully mobilized and repositioned as planned without the need for intraoperative conversion. Unit of Measure: Percentage of participants (%) Time Frame: up 30 days postsurgery.
8 secondary outcomes
Postoperative Complications
Time frame: From enrollment to 4 weeks postsurgery
Menstrual Function
Time frame: From enrollment then at 4, 8, 12 weeks and 52 weeks after surgery
Hormonal Function: Follicle-Stimulating Hormone (FSH)
Time frame: From enrollment then at 4, 8, 12 weeks and 52 weeks after surgery
Hormonal Function: Luteinizing Hormone (LH)
Time frame: From enrollment then at 4, 8, 12 weeks and 52 weeks after surgery
Hormonal Function: Anti-Mullerian Hormone (AMH)
Time frame: From enrollment then at 4, 8, 12 weeks and 52 weeks after surgery
Hormonal Function: Estradiol
Time frame: From enrollment then at 4, 8, 12 weeks and 52 weeks after surgery
Quality of Life: FSFI survey
Time frame: At enrollment then at 12 weeks and 52 weeks after surgery
Quality of Life: EORTC QLC-C30
Time frame: At enrollment then at 12 weeks and 52 weeks after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Background: PubMed 40609092Apelian S, Vest A, Yasukawa M, Wellcome J, Kohut A, Imudia AN, Tuli R, Anderson ML, Rutherford T, Andikyan V. Uterine Transposition for Fertility Preservation and Ovarian Conservation in Patients Undergoing Pelvic Radiotherapy. Obstet Gynecol. 2025 Nov 1;146(5):679-689. doi: 10.1097/AOG.0000000000005954. Epub 2025 Jul 3.
- Background: PubMed 37898483Ribeiro R, Baiocchi G, Moretti-Marques R, Linhares JC, Costa CN, Pareja R. Uterine transposition for fertility and ovarian function preservation after radiotherapy. Int J Gynecol Cancer. 2023 Dec 4;33(12):1837-1842. doi: 10.1136/ijgc-2023-004723.
- Background: PubMed 28697913Ribeiro R, Rebolho JC, Tsumanuma FK, Brandalize GG, Trippia CH, Saab KA. Uterine transposition: technique and a case report. Fertil Steril. 2017 Aug;108(2):320-324.e1. doi: 10.1016/j.fertnstert.2017.06.016. Epub 2017 Jul 8.
- Individual participant dataSharing planned: Yes. Upon reasonable request, deidentified clinical data generated during the study will be available from the principal investigator, Dr. Vaagn Andikyan.
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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.
Vaagn Andikyan principal investigator
USF Health Morsani College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uteroovarian transposition in people with Colorectal (Colon or Rectal) Cancer and Pelvic Malignancies, run by University of South Florida at 1 site in United States.
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 14 inclusion and 35 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: looking for participants now, as of the sponsor's last update on 24 Jun 2026. 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 United States. 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?
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 Brittani Powell, MPH, CCRP ((813) 974-5638, RSCH-IRB@usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of uterine transposition (time frame: From enrollment to completion of surveillance/monitoring at 52 weeks). 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 NCT07419490, which also lists 3 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 24 Jun 2026.