Infertility Clinical Trial
Official title:
Transplantation of Ovarian Tissue Into the Pelvic Wall and the Ovary After Cryopreservation of Ovarian Tissue Before Cytotoxic Therapies - Where do More Follicles Grow?
The purpose of this study is to determine whether the pelvic wall or the ovary represents a better location for the maturation of follicles in the context of ovarian transplantation after cryopreservation of ovarian tissue before cytotoxic therapies.
The development of modern medicine made it more likely for oncological patients to survive.
Also, there are a lot of young female patients with a persistent wish for kids. After an
aggressive chemotherapy, premature ovarian failure (POF) is a possible consequence of the
therapy. Therefore, efficient fertility protective interventions are requested. The
transplantation of ovarian tissue after cryopreservation is a valuable method, which could
remain fertility after POF induced by cytotoxic therapies. Especially for girls suffering
from cancer, who didn't reach puberty yet, cryopreservation of ovarian tissue is the only
opportunity to preserve a chance of restoring fertility after POF.
There are two locations, which could be used for the retransplantation of the cryopreserved
tissue: the remaining ovary and the pelvic wall. Both, the ovary and the subperitoneal pocket
in the pelvic wall present a location, where the maturation of follicles is possible. The
remaining question is: where do more follicles grow? To answer this question, a study will be
necessary. The purpose of this study is to determine whether the pelvic wall or the ovary
represents a better location for the maturation of follicles in the context of ovarian
transplantation after cryopreservation of ovarian tissue before cytotoxic therapies.
Interventions:
Ovarian tissue will be transplanted into two different locations; subperitoneal into the loge
of the adnexa of uterus and contralateral into the ovary. The assignment of the two parts of
ovarian tissue to the place of transplantation (pelvic wall vs. ovary) will be randomised.
The study-specific interventions include:
- Transplantation of the same amount of ovarian tissue into both locations
- Monthly sonographic controls and determination of estradiol, LH, FSH and progesterone
from the 3rd on to the 12th month after the transplantation. Therefore, blood samples
will be made.
- Monthly documentation of the duration of the cycle from the 3rd on to the 12th month
after transplantation
One year after the transplantation, the investigators will be able to determine which
location is more likely to grow follicles. With the gained knowledge, standardized
recommendations could be formulated which help to improve the whole process of medical care
of female oncologist patients.
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