Ovarian Tissue Cryopreservation Combined With Oocyte Cryopreservation Versus Oocyte Cryopreservation Alone

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.

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 Overview

• Status: Recruiting
• Conditions: Fertility Preservation; Oncological Disease

• Study Type: Observational
• Enrollment (Estimated): 127

Contacts and Locations

• Study Contact: Name: Diego Raimondo, MD; Phone Number: +393290636618; Email: die.raimondo@gmail.com

Study Locations

• Italy
  • Bologna
    • Bologna, Bologna, Italy, 40138
      • Recruiting
      • IRCCS Azienda Ospedaliero-Universitaria di Bologna
      • Contact: Diego Raimondo, MD; Phone Number: +393290636618; Email: die.raimondo@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• Patient with oncological disease eligible for potentially gonadotoxic therapy
• BMI ≥ 17.5 kg/m² and ≤ 32 kg/m²
• Age ≥ 18 years and ≤ 46 years

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 hours after oocyte retrieval

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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)	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	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	Within 7 days after oocyte retrieval

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2025
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): September 1, 2029

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: April 20, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: COMBINGLE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No