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

Infertility Clinical Trial

— 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?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02780791
• Other study ID #: 2016-OVARTRANS
• Status: Terminated
• Phase: N/A
• Start date: September 10, 2017
• Est. completion date: July 31, 2020

Study information

• Verified date: August 2020
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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!

Related Conditions & MeSH terms

• Infertility
• Ovarian Failure, Premature
• Premature Birth
• Primary Ovarian Insufficiency

Intervention

Other:
• Transplantation into pelvic wall
Ovarian tissue will be transplanted subperitoneal into the loge of the adnexa of Uterus.
• Transplantation into the ovary
Ovarian tissue will be transplanted contralateral into the ovary.

Locations

Country	Name	City	State
Switzerland	Universitätsfrauenklinik, Abteilung für Gynäkologische Endokrinologie und Reproduktionsmedizin	Bern	BE

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Beginning 3 months after the transplantation until 12 months after the transplantation
Secondary	Number of study participants with pregnancy	Documentation of pregnancy ratio after transplantation of autologous ovarian tissue	12 months after transplantation and 24 months after transplantation
Secondary	Number of study participants with life-birth after pregnancy	Documentation of life-birth ratio after pregnancy in context after transplantation of autologous ovarian tissue	12 months after transplantation and 24 months after transplantation
Secondary	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.	Beginning 3 months after the transplantation until 12 months after the transplantation
Secondary	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).	Beginning 3 months after the transplantation until 12 months after the transplantation