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Patient qualification

Candidates for the project on fertility preservation with the use of oogonial stem cells

Candidates for participation in the project will be recruited among women at risk of POF.

The following candidates will be considered for the Project:

  • women (and girls) under the age of 43 years who, due to malignancy, have to undergo chemotherapy and/or radiotherapy that may lead to irreversible loss of their ability to produce their own healthy oocytes, mainly by causing genetic anomalies in the DNA of the oocytes themselves (mutagenic effects of radiation and some anticancer drugs);
  • women who need to delay pregnancy due to general malignancy that can be treated only with agents that are potentially toxic to the ovaries or with teratogens;
  • women with mild ovarian disease (e.g. severe ovarian endometriosis or bilateral ovarian cysts), which over time may lead to the gradual destruction of the ovarian tissue containing oocytes;
  •  women with POF after excluding fragile X syndrome and other autoimmune disorders.

The patients will be classified into two groups:

Group 1
40 patients before anticancer treatment who have a high risk of treatment-induced POF

Group 2
40 patients with idiopathic POF

Patient group selection:
Recruitment of 80 patients who will give their written informed consent to donate fragments of the ovarian cortex for research purposes.

Inclusion criteria:

  • age 23-43 years;
  • no contraindications to pregnancy;
  • no contraindications to laparoscopic collection of ovarian cortex tissue;
  • no irreversible damage to the uterus;
  • no history of chemo- or radiotherapy.


Group 1: 40 patients prior to anticancer treatment who are at high risk of POF

• diagnosis of cancer in the absence of ovarian involvement;
• serum levels of anti-Müllerian hormone (AMH) ≥1.4 ng/mL
• > 4 antral follicles assessed by ultrasound
• good cancer survival prognosis

Group 2: 40 patients with idiopathic POF

• Serum AMH between 0.1 and 0.7 ng/mL

Exclusion criteria:

  • chronic conditions that significantly increase health risk;
  • age over 43 years;
  • pelvic damage;
  • previous cancer treatment.

 

Expected benefits for patients:

It is expected that this medical experiment will provide its participants with therapeutic benefit in the form of healthy pregnancy, which is currently impossible to achieve in this group of patients.

The use of donor cells will be avoided in these patients

Possible adverse effects of the experiment:
Complications related to endoscopic procedures (laparoscopy),
Complications related to general anaesthesia.

The experimental protocol:

  1. Collecting a fragment of the ovarian cortex to preserve or restore female fertility in patients at risk of POF.
  2. Selection and isolation of DDX4+ oogonial stem cells.
  3. Culturing stem cells for their multiplication and differentiation into oocytes.
  4. Screening the eggs for genetics and expression of genes characteristic of mature eggs.
  5. Freezing mature eggs.
  6. IVF to obtain an embryo and embryo transfer into the uterus.

 

Files to download

Consent to participate in the experiment
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