Maturation of Follicles After Transplantation of Ovarian Tissue Into the Pelvic Wall and the Ovary (Ovartrans)
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|ClinicalTrials.gov Identifier: NCT02780791|
Recruitment Status : Enrolling by invitation
First Posted : May 23, 2016
Last Update Posted : November 28, 2016
|Condition or disease||Intervention/treatment||Phase|
|Infertility Ovarian Failure, Premature||Other: Transplantation into pelvic wall Other: Transplantation into the ovary||Early Phase 1|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||December 2016|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||March 2020|
Active Comparator: Transplantation into pelvic wall
Ovarian transplantation into the pelvic wall after cryopreservation of ovarian tissue before cytotoxic therapies
Other: Transplantation into pelvic wall
Ovarian tissue will be transplanted subperitoneal into the loge of the adnexa of Uterus.
Active Comparator: Transplantation into the ovary
Ovarian transplantation into ovary after cryopreservation of ovarian tissue before cytotoxic therapies
Other: Transplantation into the ovary
Ovarian tissue will be transplanted contralateral into the ovary.
- Comparison of follicle maturation in transplanted tissue between pelvic wall and ovary [ Time Frame: Beginning 3 months after the transplantation until 12 months after the transplantation ]
The participants will get an assessment of the follicle maturation on both sides (pelvic wall and ovary) each month beginning 3 months after the transplantation until 12 months after the transplantation. Overall, 10 assessments will take place. The maturation of follicles will be detected with sonography and measured in mm.
Along with the sonography, blood samples will be taken and examined for their amount of estradiol, FSH and progesterone. A follicle ≥15mm with a concentration of estradiol >500 pmol/L (>136pg/ml) is considered a mature follicle.
The primary outcome contains the quantitative comparison of mature follicles grown on both sides.
- Duration of cycle, measured in weeks [ Time Frame: Beginning 3 months after the transplantation until 12 months after the transplantation ]The participants will be asked for the duration of their last cycle (2, 3, 4, 5, 6, 7, 8 weeks or no cycle). The assessments will take place monthly, beginning 3 months after the transplantation until 12 months after the transplantation.
- Number of study participants with pregnancy [ Time Frame: 12 months after transplantation and 24 months after transplantation ]Documentation of pregnancy ratio after transplantation of autologous ovarian tissue
- Number of study participants with life-birth after pregnancy [ Time Frame: 12 months after transplantation and 24 months after transplantation ]Documentation of life-birth ratio after pregnancy in context after transplantation of autologous ovarian tissue
- Determination of hormone levels after transplantation, concerning the concentration of estradiol, progesterone, LH, FSH [ Time Frame: Beginning 3 months after the transplantation until 12 months after the transplantation ]Blood samples will be examined for their amount of estradiol, progesterone, FSH and LH in order to check the vitality and the functionality of the transplanted tissue.
- Sonographic measurement of the endometrium wall, measured in mm [ Time Frame: Beginning 3 months after the transplantation until 12 months after the transplantation ]Monthly sonographic measurement of the endometrium wall will be performed. Along with the determination of hormone levels after the transplantation, these measurements hold a more detailed evaluation of the activity of the transplanted tissue and his effect on a functional organ (e.g. endometrium).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02780791
|Principal Investigator:||Michael von Wolff, Prof.Dr.med.||Universitätsfrauenklinik, Abteilung für Gynäkologische Endokrinologie und Reproduktionsmedizin, Effingerstrasse 102, 3010 Bern|