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

NCT ID: NCT02780791

Last Updated: 2020-08-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-10
• Study Completion Date: 2020-07-31

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.

Conditions

Infertility; Ovarian Failure, Premature

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Transplantation into pelvic wall

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

Group Type: ACTIVE_COMPARATOR

Transplantation into pelvic wall

Intervention Type: OTHER

Ovarian tissue will be transplanted subperitoneal into the loge of the adnexa of Uterus.

Transplantation into the ovary

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

Group Type: ACTIVE_COMPARATOR

Transplantation into the ovary

Intervention Type: OTHER

Ovarian tissue will be transplanted contralateral into the ovary.

Interventions

Transplantation into pelvic wall

Ovarian tissue will be transplanted subperitoneal into the loge of the adnexa of Uterus.

Intervention Type: OTHER

Transplantation into the ovary

Ovarian tissue will be transplanted contralateral into the ovary.

Intervention Type: OTHER

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!

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael von Wolff, Prof.Dr.med.

Role: PRINCIPAL_INVESTIGATOR

Universitätsfrauenklinik, Abteilung für Gynäkologische Endokrinologie und Reproduktionsmedizin, Effingerstrasse 102, 3010 Bern

Locations

Universitätsfrauenklinik, Abteilung für Gynäkologische Endokrinologie und Reproduktionsmedizin

Bern, Canton of Bern, Switzerland

Countries

Switzerland

Other Identifiers

2016-OVARTRANS

Identifier Type: -

Identifier Source: org_study_id