InfertilityOvartransNCT02780791
Maturation of Follicles After Transplantation of Ovarian Tissue Into the Pelvic Wall and the Ovary
A study testing Transplantation into pelvic wall and Transplantation into the ovary in people with Infertility and Ovarian Failure, Premature, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Ovarian Failure, Premature
- What is being tested?
- Transplantation into pelvic wall and Transplantation into the ovary
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Sep 2017to 31 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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!
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Universitätsfrauenklinik, Abteilung für Gynäkologische Endokrinologie und Reproduktionsmedizin
Bern, Canton of Bern, 3010
About this study
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?
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.
Read the 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.
- Conditions
- Infertility, Ovarian Failure, Premature
- Being tested
- Transplantation into pelvic wall, Transplantation into the ovary
- 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
- Medical subject headings
- Infertility, Primary Ovarian Insufficiency, Menopause, Premature, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transplantation into pelvic wallOther
Ovarian tissue will be transplanted subperitoneal into the loge of the adnexa of Uterus.
Transplantation into the ovaryOther
Ovarian tissue will be transplanted contralateral into the ovary.
| Study group | Role | What they receive |
|---|---|---|
| Transplantation into pelvic wall | Active comparator | Ovarian transplantation into the pelvic wall after cryopreservation of ovarian tissue before cytotoxic therapies Receives: Other: Transplantation into pelvic wall |
| Transplantation into the ovary | Active comparator | Ovarian transplantation into ovary after cryopreservation of ovarian tissue before cytotoxic therapies Receives: Other: Transplantation into the ovary |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Beginning 3 months after the transplantation until 12 months after the transplantation
Secondary outcomes (5)
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.
Measured: 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
Measured: 12 months after transplantation and 24 months after transplantation
Number of study participants with life-birth after pregnancy
Documentation of life-birth ratio after pregnancy in context after transplantation of autologous ovarian tissue
Measured: 12 months after transplantation and 24 months after transplantation
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.
Measured: Beginning 3 months after the transplantation until 12 months after the transplantation
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).
Measured: Beginning 3 months after the transplantation until 12 months after the transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2016 (estimated)
- Study start10 Sep 2017
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Why it stopped: Insufficient recruited participants due to a lack of collaborating study centers
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael von Wolff, Prof.Dr.med., Principal investigator, Universitätsfrauenklinik, Abteilung für Gynäkologische Endokrinologie und Reproduktionsmedizin, Effingerstrasse 102, 3010 Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02780791
- Sponsor's protocol ID
- 2016-OVARTRANS
- Acronym
- Ovartrans
- Status last verified
- Aug 2020
- First submitted
- 29 Apr 2016
- Last updated
- 14 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT02780791
- Acronym / sponsor ID
- Ovartrans / 2016-OVARTRANS
- Conditions
- Infertility, Ovarian Failure, Premature
- Keywords
- Infertility, Ovarian Failure, Premature, Ovarian Follicle, Ovary, Tissue Transplantation, Cryopreservation, Pelvis, Chemotherapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruited participants due to a lack of collaborating study centers
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 10 Sep 2017 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 23 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transplantation into pelvic wall | Active comparator | Other: Transplantation into pelvic wallOvarian transplantation into the pelvic wall after cryopreservation of ovarian tissue before cytotoxic therapies |
| Transplantation into the ovary | Active comparator | Other: Transplantation into the ovaryOvarian transplantation into ovary after cryopreservation of ovarian tissue before cytotoxic therapies |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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!
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transplantation into pelvic wallOvarian tissue will be transplanted subperitoneal into the loge of the adnexa of Uterus. | Other | Transplantation into pelvic wall |
| Transplantation into the ovaryOvarian tissue will be transplanted contralateral into the ovary. | Other | Transplantation into the ovary |
Primary outcome
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.
5 secondary outcomes
Duration of cycle, measured in weeks
Time frame: 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
Number of study participants with life-birth after pregnancy
Time frame: 12 months after transplantation and 24 months after transplantation
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
Sonographic measurement of the endometrium wall, measured in mm
Time frame: Beginning 3 months after the transplantation until 12 months after the transplantation
Results and safety
The study was stopped early (reason given: Insufficient recruited participants due to a lack of collaborating study centers). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael von Wolff, Prof.Dr.med. principal investigator
Universitätsfrauenklinik, Abteilung für Gynäkologische Endokrinologie und Reproduktionsmedizin, Effingerstrasse 102, 3010 Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transplantation into pelvic wall and Transplantation into the ovary in people with Infertility and Ovarian Failure, Premature, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient recruited participants due to a lack of collaborating study centers). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2020.