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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000019204
Receipt No. R000021814
Scientific Title Induction of follicle development in poor responder patients based on suppression of Hippo signaling
Date of disclosure of the study information 2015/10/02
Last modified on 2017/04/12

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Basic information
Public title Induction of follicle development in poor responder patients based on suppression of Hippo signaling
Acronym Induction of follicle development in poor responder.
Scientific Title Induction of follicle development in poor responder patients based on suppression of Hippo signaling
Scientific Title:Acronym Induction of follicle development in poor responder.
Region
Japan

Condition
Condition Poor responder infertility patients
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The success of IVF treatment in poor responder patients is low due to decreases in the number of retrieved oocytes. Recent study demonstrated that suppression of Hippo signaling in somatic cells of ovarian follicles induced secondary follicle growth, resulting in increases in the number of antral follicles. To improve the outcome of IVF treatment in poor responder patients, we establish the method to increases the number of retrieved oocytes by induction of secondary follicle growth through ovarian tissue removal and fragmentation with in vitro culture followed by auto-transplantation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Comparison of the number of oocytes retrieved after ovarian stimulation with those of base line numbers.
Key secondary outcomes Comparison of proportions of fertilization, pregnancy and abortion with those of base line levels. Comparison of the levels of molecular markers reflecting the results of Hippo signal suppression in ovarian tissues and serum before and after culture and grafting operation, respectively. Also, we count the number of secondary follicles in grafting tissues by histological analysis.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 1) Correct serum from the patients before surgery to measure molecular markers to ensure suppression of Hippo signaling.
2) Excise one side of whole ovary or partial ovarian tissues under laparoscopic surgery. After removal of medulla tissues to prepare ovarian cortex, the ovarian cortex was dissected into 1x1cm with 1-2mm thickness of tissue stripes. Among the cortical tissue stripes, 2-3 stripes are further cut into 1-2mm cubes. Surplus cortical tissue stripes are cryopreserved using vitrification or slow freezing method.
3) Nine to ten of ovarian cubes are put onto cell culture insert and cultured for several hours to suppress Hippo signaling. Collect some ovarian cubes before and after culture to ensure suppression of Hippo signaling.
4) After culture, ovarian cubes are washed extensively by saline. These cubes are auto-transplanted beneath of the serosa of both Fallopian tubes, remaining ovaries and/or Douglus' pouch. In some patients who have relatively better ovarian reserve, we directly cut ovarian cortex inside of the body or scratch ovarian cortex to induce physical stimulation to the ovary. From the contra lateral side of ovary, we also remove a part of ovarian cortical tissues and cut into 1-2 mm cubes.
Immediately after fragmentation of ovarian corticies, these ovarian cubes are grafted without cultures.
5) Correct serum from the patients after surgery to measure molecular markers to ensure suppression of Hippo signaling. After grafting, patients receive ovarian stimulation using gonadotropin drugs to stimulate follicle growth and retrieve oocytes. Mature oocytes are fertilized by in vitro fertilization and preimplantation embryos are transplant into uterus. The treatment continues for 1-2 years. If first auto-transplantation is not successful and patients have cryopreserved ovarian tissues, patients can repeat these procedures
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
20 years-old <=
Age-upper limit
45 years-old >
Gender Female
Key inclusion criteria All following four features must be present:
1) Advanced maternal age (=>40 years) or any other risk factor for POR
2) A previous POR (<=3 oocytes with a conventional stimulation protocol)
3) An abnormal ovarian reserve test (i.e. AFC, 5-7 follicles or AMH, 0.5-1.1 ng/ml).
4) Married women
Key exclusion criteria 1)Patients with severe ovarian dysfunction who can not retrieve oocytes after ovarian stimulation.
2)Patients with high risk for laparoscopy.
3)Patients who can not obtain written informed consent.
4)Patients judged to be inappropriate for the study by the physicians.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Tanaka
Organization Saint Mother Hospital
Division name
Zip code
Address 4-9-12 Orio Yahatanishiku, Kitakyusyu, Fukuoka, JAPAN
TEL 093-601-2000
Email incho@stmother.com

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Tanaka
Organization Saint Mother Hospital
Division name
Zip code
Address 4-9-12 Orio Yahatanishiku, Kitakyusyu, Fukuoka, JAPAN
TEL 093-601-2000
Homepage URL
Email incho@stmother.com

Sponsor
Institute Saint Mother Hospital
Institute
Department

Funding Source
Organization Saint Mother Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 セントマザー産婦人科医院(福岡県)

Other administrative information
Date of disclosure of the study information
2015 Year 10 Month 02 Day

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
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 Open public recruiting
Date of protocol fixation
2015 Year 08 Month 11 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 01 Day
Last follow-up date
2021 Year 12 Month 01 Day
Date of closure to data entry
2021 Year 12 Month 01 Day
Date trial data considered complete
2021 Year 12 Month 01 Day
Date analysis concluded
2021 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2015 Year 10 Month 02 Day
Last modified on
2017 Year 04 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021814

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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