Study Stopped
Insufficient recruited participants due to a lack of collaborating study centers
Maturation of Follicles After Transplantation of Ovarian Tissue Into the Pelvic Wall and the Ovary
Ovartrans
Transplantation of Ovarian Tissue Into the Pelvic Wall and the Ovary After Cryopreservation of Ovarian Tissue Before Cytotoxic Therapies - Where do More Follicles Grow?
1 other identifier
interventional
1
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2016
CompletedFirst Posted
Study publicly available on registry
May 23, 2016
CompletedStudy Start
First participant enrolled
September 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2020
CompletedAugust 14, 2020
August 1, 2020
2.9 years
April 29, 2016
August 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of follicle maturation in transplanted tissue between pelvic wall and ovary
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.
Beginning 3 months after the transplantation until 12 months after the transplantation
Secondary Outcomes (5)
Duration of cycle, measured in weeks
Beginning 3 months after the transplantation until 12 months after the transplantation
Number of study participants with pregnancy
12 months after transplantation and 24 months after transplantation
Number of study participants with life-birth after pregnancy
12 months after transplantation and 24 months after transplantation
Determination of hormone levels after transplantation, concerning the concentration of estradiol, progesterone, LH, FSH
Beginning 3 months after the transplantation until 12 months after the transplantation
Sonographic measurement of the endometrium wall, measured in mm
Beginning 3 months after the transplantation until 12 months after the transplantation
Study Arms (2)
Transplantation into pelvic wall
ACTIVE COMPARATOROvarian transplantation into the pelvic wall after cryopreservation of ovarian tissue before cytotoxic therapies
Transplantation into the ovary
ACTIVE COMPARATOROvarian transplantation into ovary after cryopreservation of ovarian tissue before cytotoxic therapies
Interventions
Ovarian tissue will be transplanted subperitoneal into the loge of the adnexa of Uterus.
Ovarian tissue will be transplanted contralateral into the ovary.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Age at transplantation \<18 and \>49 years
- Cryopreservation in the context of a leucaemia, neuroblastoma, Burkitt-lymphoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universitätsfrauenklinik, Abteilung für Gynäkologische Endokrinologie und Reproduktionsmedizin
Bern, Canton of Bern, 3010, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael von Wolff, Prof.Dr.med.
Universitätsfrauenklinik, Abteilung für Gynäkologische Endokrinologie und Reproduktionsmedizin, Effingerstrasse 102, 3010 Bern
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2016
First Posted
May 23, 2016
Study Start
September 10, 2017
Primary Completion
July 31, 2020
Study Completion
July 31, 2020
Last Updated
August 14, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will share
The Source data will include: * All documents required in the Trial master file * Visit dates and participation in the study along with consent forms * Completed CRFs and patient medical charts * All documentation related to SAEs and AEs * All documentation related to concomitant medication and results of study relevant examinations Direct access to source documents will be permitted for purposes of monitoring, audits and inspections. Access to protocol, dataset, statistical code during and after the study will be given to the PI, the other defined investigators, the persons who perform the monitoring and the statistician. The key to decode the health related data will be stored at the Universitätsfrauenklinik, Abteilung Gynäkologische Endokrinologie und Reproduktionsmedizin, Effingerstrasse 102, 3010 Bern. The access to the key will only be given to persons, who need it to fulfill their tasks in the sense of the study.