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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000026041 |
Receipt No. | R000029926 |
Scientific Title | The safety and effect of embryo cryopreservation for fertility preservation |
Date of disclosure of the study information | 2017/02/09 |
Last modified on | 2020/08/18 |
Basic information | ||
Public title | The safety and effect of embryo cryopreservation for fertility preservation | |
Acronym | The safety and effect of embryo cryopreservation for fertility preservation | |
Scientific Title | The safety and effect of embryo cryopreservation for fertility preservation | |
Scientific Title:Acronym | The safety and effect of embryo cryopreservation for fertility preservation | |
Region |
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Condition | ||||||||||||
Condition | Cancer, Hematologic disease,Collagen disease, | |||||||||||
Classification by specialty |
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Classification by malignancy | Malignancy | |||||||||||
Genomic information | NO |
Objectives | |
Narrative objectives1 | In this study, we conduct embryo cryopreservation for fertility preservation and investigate the influence on primary disease, pregnancy rare of frozen embryo transfer, and safety in pregnancy. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | The recurrence of primary disease, Newborn anomalies and malformations |
Key secondary outcomes | Oocytes retrieved, Fertilization rate, Ovarian reserve after treatment of primary disease |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Patients undergo stimulation and in vitro fertilization(IVF) for fertility preservation before or in the course of treatment for primary disease.
Combined therapy: one FSH/hMG injection(150-450 IU)per day with GnRH agonist or GnRH antagonist until maturation of follicles, one hCG injection (5000-15000 IU)per day when follicles mature. |
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Interventions/Control_2 | ||
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Female | |||
Key inclusion criteria | 1)Cancer, hematological disease, or collagen disease patients.
2)The physicians of primary disease make a written request for fertility preservation. 3)The patients who are expected long-term survival. 4)The patients who have the ability to provide written informed consent. |
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Key exclusion criteria | 1)The patients who are not expected long-term survival.
2)The patients who have the previous history of gynecologic malignant diseases (ovarian cancer, cervical adenocarcinoma) 3)The patients who are during the period of pregnancy or the possibility of pregnancy. 4)The patients judged to be inappropriate for the study by the physicians. |
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Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | St. Marianna University of Medicine | ||||||
Division name | Department of Obstetrics and Gynecology | ||||||
Zip code | 2168511 | ||||||
Address | 2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511 Japan | ||||||
TEL | 044-977-8111 | ||||||
nao@marianna-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | St. Marianna University of Medicine | ||||||
Division name | Department of Obstetrics and Gynecology | ||||||
Zip code | 2168511 | ||||||
Address | 2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511 Japan | ||||||
TEL | 044-977-8111 | ||||||
Homepage URL | |||||||
nao@marianna-u.ac.jp |
Sponsor | |
Institute | St. Marianna University of Medicine |
Institute | |
Department |
Funding Source | |
Organization | St. Marianna University of Medicine |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | IRB of St. Marianna University |
Address | 2-16-1 Sugao, Miyamae-ku, Kawasaki Kanagawa JAPAN. |
Tel | 044-977-8111 |
k-sienbu.mail@marianna-u.ac.jp |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | Totally 30 contributors received oocyte pick up before cancer treatment as fertility preservation. Until now, they don't have any side effect. We will follo up them to assess the ling term efficathy and safety. |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Enrolling by invitation | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029926 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |