Clinical trial NCT02780791: Maturation of Follicles After Transplantation of Ovarian Tissue Into the Pelvic Wall and the Ovary
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?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infertility
Ovarian Failure, Premature
Keywords: Infertility
Ovarian Failure, Premature
Ovarian Follicle
Ovary
Tissue Transplantation
Cryopreservation
Pelvis
Chemotherapy
Pregnancy Rate
Folliculogenesis
Endometrium
Estrogens
Progestins
Follicle Stimulating Hormone
Estradiol
Progesterone
Hormones
Maturation of Follicles
Pregnant Women
Premature Menopause
Ovarian Insufficiency
Ovarian Insufficiency, Premature
Cytotoxic therapy
Fertility Protection
Reproductive Medicine
Reproductive Techniques
Reproductive Technology
Cryotherapy
Pregnancy
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2016-05-23
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age at cryopreservation ot tissue max. 38 years
* Age at transplantation 18-49 years
* At least one maintained ovary
* Premature ovarian failure
* Indication for an autologous transplantation of ovarian tissue
* Permitted pregnancy from the part of the oncologists
* Written informed consent

Exclusion Criteria:

* Age at transplantation \<18 and \>49 years
* Cryopreservation in the context of a leucaemia, neuroblastoma, Burkitt-lymphoma

Important: Inclusion is only done by one of the recruiting centers. Study participation will only be given on invitation. Please contact Principal Investigator!

Primary outcomes:
measure: Comparison of follicle maturation in transplanted tissue between pelvic wall and ovary
timeFrame: Beginning 3 months after the transplantation until 12 months after the transplantation
Secondary outcomes:
measure: Duration of cycle, measured in weeks
timeFrame: Beginning 3 months after the transplantation until 12 months after the transplantation
measure: Number of study participants with pregnancy
timeFrame: 12 months after transplantation and 24 months after transplantation
measure: Number of study participants with life-birth after pregnancy
timeFrame: 12 months after transplantation and 24 months after transplantation
measure: Determination of hormone levels after transplantation, concerning the concentration of estradiol, progesterone, LH, FSH
timeFrame: Beginning 3 months after the transplantation until 12 months after the transplantation
measure: Sonographic measurement of the endometrium wall, measured in mm
timeFrame: Beginning 3 months after the transplantation until 12 months after the transplantation
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Universitätsfrauenklinik, Abteilung für Gynäkologische Endokrinologie und Reproduktionsmedizin
state: BE
Study officials:
affiliation: Universitätsfrauenklinik, Abteilung für Gynäkologische Endokrinologie und Reproduktionsmedizin, Effingerstrasse 102, 3010 Bern
name: Michael von Wolff, Prof.Dr.med.
role: PRINCIPAL_INVESTIGATOR
References: