Oncological DiseaseNCT07546123
Ovarian Tissue Cryopreservation Combined With Oocyte Cryopreservation Versus Oocyte Cryopreservation Alone
An observational study of Oncological Disease and Fertility Preservation, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
Fertility preservation is a crucial aspect of care for oncological patients undergoing gonadotoxic treatments such as chemotherapy, radiotherapy, or surgery, which can significantly reduce ovarian reserve and cause infertility or premature menopause. Read more about this study
- Who is it for?
- Ages 18 to 46 years, women only
- Conditions the study is for
- Oncological Disease, Fertility Preservation
- How many people
- 127 participants
- Where
- 1 siteItaly
- Study dates
- 25 Aug 2025to Sep 2029
- 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 46 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients diagnosed with oncological disease attending the UO Gynecology and Human Reproduction Pathophysiology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di S. Orsola, for fertility preservation through ovarian tissue cryopreservation and/or oocyte cryopreservation.
Who may be able to join
- Patient with oncological disease eligible for potentially gonadotoxic therapy
- BMI ≥ 17.5 kg/m² and ≤ 32 kg/m²
- Age ≥ 18 years and ≤ 46 years
Who cannot join
- Hypersensitivity to one or more of the active substances used during ovarian stimulation treatment
- Positive for HBV, HCV, HIV, or Treponema pallidum
- Lack of oncological clearance
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
Diego Raimondo, MD, +393290636618, die.raimondo@gmail.com
About this study
Official title: Ovarian Tissue Cryopreservation Combined With Oocyte Cryopreservation Versus Oocyte Cryopreservation Alone: an Observational Study in Oncology Patients
Fertility preservation is a crucial aspect of care for oncological patients undergoing gonadotoxic treatments such as chemotherapy, radiotherapy, or surgery, which can significantly reduce ovarian reserve and cause infertility or premature menopause. Among available techniques, oocyte cryopreservation is well-established with high survival rates but requires controlled ovarian stimulation and may not be suitable for prepubertal patients or those needing urgent cancer therapy. Ovarian tissue cryopreservation offers advantages by preserving a larger number of primordial follicles, can be performed anytime in the menstrual cycle regardless of age, and also helps restore ovarian endocrine function.
Combining ovarian tissue cryopreservation followed by oocyte cryopreservation may maximize fertility preservation by safeguarding more follicles and ensuring availability of mature oocytes.
Read more
This study will collect data from two patient groups:
Group 1: patients undergoing ovarian tissue cryopreservation followed by oocyte cryopreservation (combined treatment)
Group 2: patients undergoing oocyte cryopreservation alone.
Group assignment is based on planned gonadotoxic therapy and available time before treatment initiation, according to clinical practice.
The study aims to compare the number of oocytes retrieved per ovarian stimulation cycle between the two groups, along with the oocyte retrieval rate (number of oocytes retrieved/number of aspirated follicles), number of mature oocytes (metaphase II), incidence of moderate ovarian hyperstimulation syndrome within 7 days post-retrieval, and correlations between serum estradiol and luteinizing hormone levels on trigger day and oocyte yield.
Approximately 127 patients aged 18 to 46 will be consecutively enrolled at the UO Gynecology and Human Reproduction Pathophysiology, IRCCS AOUBO Policlinico di Sant'Orsola. This is a cross-sectional, single-center, observational study with both retrospective and prospective enrollment. The retrospective period considered is from January 1, 2022, to the study start date. The study duration is 4 years and 3 months.
- Conditions
- Oncological Disease, Fertility Preservation
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the number of oocytes retrieved per stimulation cycle in oncology patients undergoing fertility preservation before gonadotoxic therapy: ovarian tissue cryopreservation followed by oocyte cryopreservation vs. oocyte cryopreservation alone
Count of oocytes retrieved
Measured: 2 hours after oocyte retrieval
Secondary outcomes (5)
To compare the oocyte retrieval rate (number of oocytes retrieved / number of aspirated follicles) between the two previously described patient groups.
Number of oocytes retrieved / number of aspirated follicles
Measured: 2 hours after oocyte retrieval
To compare the number of mature oocytes retrieved (defined as the number of metaphase II oocytes) between the two groups.
Count of retrieved metaphase II oocytes
Measured: 2 hours after oocyte retrieval
To compare the number of patients who develop moderate ovarian hyperstimulation syndrome (OHSS) (defined by presence of ascites, maximum ovarian diameter ≥ 8 cm, hematocrit ≥ 45%, symptoms such as abdominal pain, abdominal distension, or dyspne
Number of patients presenting with moderate or severe ovarian hyperstimulation syndrome (OHSS) (defined by the presence of ascites, maximum ovarian diameter ≥ 8 cm, hematocrit ≥ 45%, symptoms including abdominal pain, abdominal distension, and dyspnea)
Measured: Within 7 days after oocyte retrieval.
To assess whether increasing serum levels of estradiol (E2) (pg/mL) and luteinizing hormone (LH), measured on the day of ovulation trigger, correspond to a higher number of oocytes retrieved in the two previously described patient groups.
Estradiol (E2) measured in pg/mL / number of oocytes retrieved
Measured: 2 hours after oocyte retrieval]
To compare the number of patients who develop hemoperitoneum and/or pelvic infections between the two groups.
Development of hemoperitoneum and/or pelvic infections
Measured: Within 7 days after oocyte retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start25 Aug 2025
- Primary completionJul 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oncological DiseaseStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 127 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07546123
- Sponsor's protocol ID
- COMBINGLE
- Status last verified
- Apr 2026
- First submitted
- 26 Nov 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ovarian Tissue Cryopreservation Combined With Oocyte Cryopreservation Versus Oocyte Cryopreservation Alone: an Observational Study in Oncology Patients
- ClinicalTrials.gov ID
- NCT07546123
- Acronym / sponsor ID
- COMBINGLE
- Conditions
- Oncological Disease, Fertility Preservation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 127 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 22 Apr 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.
Fertility preservation is a crucial aspect of care for oncological patients undergoing gonadotoxic treatments such as chemotherapy, radiotherapy, or surgery, which can significantly reduce ovarian reserve and cause infertility or premature menopause. Among available techniques, oocyte cryopreservation is well-established with high survival rates but requires controlled ovarian stimulation and may not be suitable for prepubertal patients or those needing urgent cancer therapy. Ovarian tissue cryopreservation offers advantages by preserving a larger number of primordial follicles, can be performed anytime in the menstrual cycle regardless of age, and also helps restore ovarian endocrine function.
Combining ovarian tissue cryopreservation followed by oocyte cryopreservation may maximize fertility preservation by safeguarding more follicles and ensuring availability of mature oocytes.
This study will collect data from two patient groups:
Group 1: patients undergoing ovarian tissue cryopreservation followed by oocyte cryopreservation (combined treatment)
Group 2: patients undergoing oocyte cryopreservation alone.
Group assignment is based on planned gonadotoxic therapy and available time before treatment initiation, according to clinical practice.
The study aims to compare the number of oocytes retrieved per ovarian stimulation cycle between the two groups, along with the oocyte retrieval rate (number of oocytes retrieved/number of aspirated follicles), number of mature oocytes (metaphase II), incidence of moderate ovarian hyperstimulation syndrome within 7 days post-retrieval, and correlations between serum estradiol and luteinizing hormone levels on trigger day and oocyte yield.
Approximately 127 patients aged 18 to 46 will be consecutively enrolled at the UO Gynecology and Human Reproduction Pathophysiology, IRCCS AOUBO Policlinico di Sant'Orsola. This is a cross-sectional, single-center, observational study with both retrospective and prospective enrollment. The retrospective period considered is from January 1, 2022, to the study start date. The study duration is 4 years and 3 months.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 46 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients diagnosed with oncological disease attending the UO Gynecology and Human Reproduction Pathophysiology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di S. Orsola, for fertility preservation through ovarian tissue cryopreservation and/or oocyte cryopreservation.
Key inclusion criteria (3 listed)
- Patient with oncological disease eligible for potentially gonadotoxic therapy
- BMI ≥ 17.5 kg/m² and ≤ 32 kg/m²
- Age ≥ 18 years and ≤ 46 years
Key exclusion criteria (3 listed)
- Hypersensitivity to one or more of the active substances used during ovarian stimulation treatment
- Positive for HBV, HCV, HIV, or Treponema pallidum
- Lack of oncological clearance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of the number of oocytes retrieved per stimulation cycle in oncology patients undergoing fertility preservation before gonadotoxic therapy: ovarian tissue cryopreservation followed by oocyte cryopreservation vs. oocyte cryopreservation alone
Time frame: 2 hours after oocyte retrieval
Count of oocytes retrieved
5 secondary outcomes
To compare the oocyte retrieval rate (number of oocytes retrieved / number of aspirated follicles) between the two previously described patient groups.
Time frame: 2 hours after oocyte retrieval
To compare the number of mature oocytes retrieved (defined as the number of metaphase II oocytes) between the two groups.
Time frame: 2 hours after oocyte retrieval
To compare the number of patients who develop moderate ovarian hyperstimulation syndrome (OHSS) (defined by presence of ascites, maximum ovarian diameter ≥ 8 cm, hematocrit ≥ 45%, symptoms such as abdominal pain, abdominal distension, or dyspne
Time frame: Within 7 days after oocyte retrieval.
To assess whether increasing serum levels of estradiol (E2) (pg/mL) and luteinizing hormone (LH), measured on the day of ovulation trigger, correspond to a higher number of oocytes retrieved in the two previously described patient groups.
Time frame: 2 hours after oocyte retrieval]
To compare the number of patients who develop hemoperitoneum and/or pelvic infections between the two groups.
Time frame: Within 7 days after oocyte retrieval
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 22 Apr 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oncological Disease and Fertility Preservation, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 3 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 22 Apr 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 Italy. 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 Diego Raimondo, MD (+393290636618, die.raimondo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the number of oocytes retrieved per stimulation cycle in oncology patients undergoing fertility preservation before gonadotoxic therapy: ovarian tissue cryopreservation followed by oocyte cryopreservation vs. oocyte cryopreservation alone (time frame: 2 hours after oocyte retrieval). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2026.