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Maturation of Follicles After Transplantation of Ovarian Tissue Into the Pelvic Wall and the Ovary (Ovartrans)

Primary Purpose

Infertility, Ovarian Failure, Premature

Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Transplantation into pelvic wall
Transplantation into the ovary
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring 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

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleAccepts Healthy Volunteers

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!

Sites / Locations

  • Universitätsfrauenklinik, Abteilung für Gynäkologische Endokrinologie und Reproduktionsmedizin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Transplantation into pelvic wall

Transplantation into the ovary

Arm Description

Ovarian transplantation into the pelvic wall after cryopreservation of ovarian tissue before cytotoxic therapies

Ovarian transplantation into ovary after cryopreservation of ovarian tissue before cytotoxic therapies

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Duration of cycle, measured in weeks
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
Documentation of pregnancy ratio after transplantation of autologous ovarian tissue
Number of study participants with life-birth after pregnancy
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
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
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).

Full Information

First Posted
April 29, 2016
Last Updated
August 12, 2020
Sponsor
Insel Gruppe AG, University Hospital Bern
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1. Study Identification

Unique Protocol Identification Number
NCT02780791
Brief Title
Maturation of Follicles After Transplantation of Ovarian Tissue Into the Pelvic Wall and the Ovary
Acronym
Ovartrans
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

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Terminated
Why Stopped
Insufficient recruited participants due to a lack of collaborating study centers
Study Start Date
September 10, 2017 (Actual)
Primary Completion Date
July 31, 2020 (Actual)
Study Completion Date
July 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transplantation into pelvic wall
Arm Type
Active Comparator
Arm Description
Ovarian transplantation into the pelvic wall after cryopreservation of ovarian tissue before cytotoxic therapies
Arm Title
Transplantation into the ovary
Arm Type
Active Comparator
Arm Description
Ovarian transplantation into ovary after cryopreservation of ovarian tissue before cytotoxic therapies
Intervention Type
Other
Intervention Name(s)
Transplantation into pelvic wall
Intervention Description
Ovarian tissue will be transplanted subperitoneal into the loge of the adnexa of Uterus.
Intervention Type
Other
Intervention Name(s)
Transplantation into the ovary
Intervention Description
Ovarian tissue will be transplanted contralateral into the ovary.
Primary Outcome Measure Information:
Title
Comparison of follicle maturation in transplanted tissue between pelvic wall and ovary
Description
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.
Time Frame
Beginning 3 months after the transplantation until 12 months after the transplantation
Secondary Outcome Measure Information:
Title
Duration of cycle, measured in weeks
Description
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.
Time Frame
Beginning 3 months after the transplantation until 12 months after the transplantation
Title
Number of study participants with pregnancy
Description
Documentation of pregnancy ratio after transplantation of autologous ovarian tissue
Time Frame
12 months after transplantation and 24 months after transplantation
Title
Number of study participants with life-birth after pregnancy
Description
Documentation of life-birth ratio after pregnancy in context after transplantation of autologous ovarian tissue
Time Frame
12 months after transplantation and 24 months after transplantation
Title
Determination of hormone levels after transplantation, concerning the concentration of estradiol, progesterone, LH, FSH
Description
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.
Time Frame
Beginning 3 months after the transplantation until 12 months after the transplantation
Title
Sonographic measurement of the endometrium wall, measured in mm
Description
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).
Time Frame
Beginning 3 months after the transplantation until 12 months after the transplantation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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!
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael von Wolff, Prof.Dr.med.
Organizational Affiliation
Universitätsfrauenklinik, Abteilung für Gynäkologische Endokrinologie und Reproduktionsmedizin, Effingerstrasse 102, 3010 Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsfrauenklinik, Abteilung für Gynäkologische Endokrinologie und Reproduktionsmedizin
City
Bern
State/Province
BE
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.

Learn more about this trial

Maturation of Follicles After Transplantation of Ovarian Tissue Into the Pelvic Wall and the Ovary

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