UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019204 |
|---|---|
| Receipt number | 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 17:44:43 |
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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
| Obstetrics 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
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
incho@stmother.com
Sponsor or person
Institute
Saint Mother Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021814
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