We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02780791
First Posted: May 23, 2016
Last Update Posted: November 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
  Purpose
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.

Condition Intervention Phase
Infertility Ovarian Failure, Premature Other: Transplantation into pelvic wall Other: Transplantation into the ovary Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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?

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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).


Estimated Enrollment: 25
Study Start Date: December 2016
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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!

  Contacts and Locations
Information from the National Library of Medicine

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


Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Principal Investigator: Michael von Wolff, Prof.Dr.med. Universitätsfrauenklinik, Abteilung für Gynäkologische Endokrinologie und Reproduktionsmedizin, Effingerstrasse 102, 3010 Bern
  More Information

Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02780791     History of Changes
Other Study ID Numbers: 2016-OVARTRANS
First Submitted: April 29, 2016
First Posted: May 23, 2016
Last Update Posted: November 28, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.


Keywords provided by University Hospital Inselspital, Berne:
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

Additional relevant MeSH terms:
Premature Birth
Infertility
Primary Ovarian Insufficiency
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Genital Diseases, Male
Genital Diseases, Female
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases