UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045017 |
|---|---|
| Receipt number | R000051131 |
| Scientific Title | A prospective randomized open-label controlled clinical trial to examine an improvement of implantation with an administration of Hishi extract. |
| Date of disclosure of the study information | 2021/07/30 |
| Last modified on | 2024/04/05 17:00:25 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A clinical trial to examine an improvement of implantation with an administration of Hishi extract.
Acronym
Hishi extract and implantation
Scientific Title
A prospective randomized open-label controlled clinical trial to examine an improvement of implantation with an administration of Hishi extract.
Scientific Title:Acronym
Hishi extract and implantation
Region
| Japan |
Condition
Condition
Infertility
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine whether an administration of Hishi extract decreases advanced glycation end-products (AGE) in the endometrium, improving pregnancy rate in cryopreserved and thawed blastocyst transfers in natural cycles.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Birth rate per embryo transfer
Key secondary outcomes
Birth rate per hCG positive, rates of implantation, clinical pregnancy, viable pregnancy, and ongoing pregnancy per transfer, and AGE levels in the endometrium.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Infertile women who meet inclusion criteria and do not meet exclusion criteria are prospectively allocated into two groups of A (Hishi group) and B (control group) at random. Women can freely decide to participate in the trial. Informed consents are obtained from all participants after they have received appropriate explanations about implications, purposes, methods, expected benefits, and possible risks, and the protection of privacy.
In the A group, serum and endometrial tissue are obtained on day 5-7 of luteal phase in the first natural cycle and administration of Hishi extract, 100 mg/day is started from the day 1 of the next 2nd natural cycle. Serum and endometrial tissue are obtained again on day 5-7 of luteal phase in this 2nd natural cycle. In the following 3rd natural cycle, cryopreserved and thawed blastocyst transfer (CT-BT) is carried out under administration of Hishi extract. If pregnancy is not obtained, administration of Hishi extract is discontinued immediately and if women wish, CT-BT is carried out without Hishi extract in the 4th natural cycle.
In natural cycles with CT-BT, ovulations may be triggered by GnRH agonist-induced LH-surge or hCG administration and luteal phase may be supported by administration of progesterone or hCG. But ovarian stimulations, hormone replacement therapy, and treatments specifically stimulating implantations must not used.
Serum and endometrial tissue are cryopreserved and analyzed later on AGE and CD138 expression.
In April, 2024, we decided to stop further retrieval of blood and endometrial tissue and to continue hereafter only CT-BT because of difficulty of subject recruitment. We had collected blood and tissue in 21 cases for 3 years until this April, 2024. Also, interim analysis detected most prominent effects in birth rate and so we changed to make birth rate per embryo transfer as primary outcome and added birth rate per hCG positive case into secondary outcomes.
Interventions/Control_2
In the B (control) group, serum and endometrial tissue are obtained on day 5-7 of luteal phase in the first natural cycle and CT-BT is carried out in the next 2nd natural cycle. When pregnancy is not achieved, administration of Hishi extract, 100 mg/day is started immediately if women wish. Serum and endometrial tissue are obtained again on day 5-7 of luteal phase in this 3rd natural cycle. In the following 4th natural cycle, CT-BT is carried out under administration of Hishi extract. If pregnancy is not obtained, administration of Hishi extract is discontinued immediately.
In April, 2024, we decided to stop further retrieval of blood and endometrial tissue and to continue hereafter only CT-BT because of difficulty of subject recruitment. We had collected blood and tissue in 20 cases for 3 years until this April, 2024. Also, interim analysis detected most prominent effects in birth rate and so we changed to make birth rate per embryo transfer as primary outcome and added birth rate per hCG positive case into secondary outcomes.
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
| 42 | years-old | >= |
Gender
Female
Key inclusion criteria
The study includes infertile women who satisfy all the following criteria; (1) she is planning to have cryopreserved-thawed blastocyst transfer (CT-BT) in natural cycles, (2) she has failed to deliver with 1-3 attempts of embryo transfer containing at least one superior blastocyst or cleaving embryo, (3) embryos used in the planning CT-BT must include at least one superior blastocyst when they were cryopreserved, which were produced by ovarian stimulation using long protocol, antagonist protocol, clomiphene citrate-hMG protocol, or PPOS, and (4) 42 years old or younger on the date of oocyte retrieval when she cryopreserved blastocysts which is used in the planning CT-BT.
Key exclusion criteria
Women are excluded when they meet any of the following criteria; (1) organic uterine infertility (Asherman syndrome, uterine anomaly, and submucosal myoma larger than 1.5 cm in diameter), (2) severe diminished ovarian reserve (AMH<0.01 ng/mL, day-3 FSH > 15 IU/L, day-3 E2 > 70pg/mL, or no ovary observed under ultrasound), (3) diabetes or taking anti-diabetic medicine, and (4) having her partner with azoospermia.
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | Masao |
| Middle name | |
| Last name | Jinno |
Organization
Wemen's Clinic Jinno
Division name
Reproductive Medicine
Zip code
182-0022
Address
3-11-7 Kokuryou-chou, Choufu City, Tokyo 182-0022, Japan
TEL
042-480-3105
mjinno@s9.dion.ne.jp
Public contact
Name of contact person
| 1st name | Masao |
| Middle name | |
| Last name | Jinno |
Organization
Women's Clinic Jinno
Division name
Reproductive Medicine
Zip code
182-0022
Address
3-11-7 Kokuryou-chou, Choufu City, Tokyo 182-0022, Japan
TEL
042-480-3105
Homepage URL
mjinno@s9.dion.ne.jp
Sponsor or person
Institute
Women's Clinic Jinno
Institute
Department
Personal name
Funding Source
Organization
Hayashikane Sangyou, Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Noboru Inagaki, M.D., Saint Women's Clinic; Moritoshi Seki, M.D., SeKiel Ladies Clinic; Yudai Tanaka, M.D., Medical Park Shounan; Keiichi Takahashi, M.D., Takahashi Women's Clinic; Toshihiko Miyazaki, M.D., Miyazaki Sanfujinka; and Junichi Kobayashi, M.D., Kanagawa Ladies Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Women's Clinic Jinno
Address
3-11-7 Kokuryou-chou, Choufu City, Tokyo 182-0022, Japan
Tel
042-480-3105
mjinno-2@air.ocn.ne.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
ウィメンズクリニック神野（東京都）、セントウィメンズクリニック（埼玉県）、セキールレディースクリニック（群馬県）、メディカルパーク湘南（神奈川県）、高橋ウィメンズクリニック（千葉県）、宮崎産婦人科（東京都）、神奈川レディースクリニック（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 30 | 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
| 2021 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 02 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 07 | Month | 30 | Day |
Last modified on
| 2024 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051131
