UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045145 |
|---|---|
| Receipt number | R000051573 |
| Scientific Title | New controlled ovarian stimulation (COS) method for polycystic ovary syndrome (PCOS) avoids ovarian hyperstimulation syndrome (OHSS) and produces higher oocyte quality resulting in highest cumulative pregnancy at one cycle. |
| Date of disclosure of the study information | 2021/08/12 |
| Last modified on | 2021/08/12 20:11:10 |
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Basic information
Public title
New controlled ovarian stimulation (COS) method for polycystic ovary syndrome (PCOS) avoids ovarian hyperstimulation syndrome (OHSS) and produces higher oocyte quality resulting in highest cumulative pregnancy at one cycle.
Acronym
New controlled ovarian stimulation (COS) method for polycystic ovary syndrome (PCOS) avoids ovarian hyperstimulation syndrome (OHSS) and produces higher oocyte quality resulting in highest cumulative pregnancy at one cycle.
Scientific Title
New controlled ovarian stimulation (COS) method for polycystic ovary syndrome (PCOS) avoids ovarian hyperstimulation syndrome (OHSS) and produces higher oocyte quality resulting in highest cumulative pregnancy at one cycle.
Scientific Title:Acronym
New controlled ovarian stimulation (COS) method for polycystic ovary syndrome (PCOS) avoids ovarian hyperstimulation syndrome (OHSS) and produces higher oocyte quality resulting in highest cumulative pregnancy at one cycle.
Region
| Japan |
Condition
Condition
Polycystic ovary syndrome(PCOS)
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We have developed new controlled ovarian stimulation (COS) method for polycystic ovary syndrome (PCOS) avoids ovarian hyperstimulation syndrome (OHSS) and produces higher-quality oocytes and verify on its efficacy and safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
To establish a new controlled ovarian stimulation (COS) protocol for polycystic ovary syndrome (PCOS) that does not cause ovarian hyper stimulation syndrome (OHSS) while maintaining egg quality.
Key secondary outcomes
1)No adverse and after effect for ovarian function following using this COS
2)Comparison of proportions of fertilization, pregnancy and abortion with those of base line levels.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
In the new COS protocol, we started with FSH injections (150IU/ml) and then continued with HMG (150IU/ml) until the injection of the trigger. GnRH antagonist shots were started when the leading follicle reached 18mm, they continued until the largest follicle was 26-28mm and the E2 level was over 3500 pg/ml. Then leuprorelin acetate (1.88mg) was injected as trigger.
One tablet of Letrozole was used when E2 level was 4000-5000 pg/ml and the total number of follicles was 20-30. Two tablets were used when E2 level was over 5000 pg/ml and there were more than 30 follicles. When E2 level was still over 2000-3000 pg/ml the following day, one tablet of Letrozole was added and trigger was injected on the same day.
In addition, after egg collection, 2 tablets each of Letrozole and Cabergoline and 1 tablet of GnRH antagonist were administered for 5 consecutive days.
Interventions/Control_2
Conventional COS-1
GnRH agonist based COS with HCG Trigger
Interventions/Control_3
Conventional COS-2
GnRH antagonist based COS with HCG Trigger
Interventions/Control_4
Conventional COS-3
GnRH antagonist based COS with GnRH agonist Trigger
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
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
1)Patient of Polycystic ovary syndrome(PCOS)
2)Married women
Key exclusion criteria
1)Patients with Severe Type2 diabetes.
2)Patients and Husband who can not obtain written informed consent.
3)Patients judged to be inappropriate for the study by the physicians.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Tanaka |
Organization
Saint Mother Clinic
Division name
Medical office
Zip code
807-0825
Address
4-9-12 Orio Yahatanishiku, Kitakyusyu Fukuoka, Japan
TEL
093-601-2000
incho@stmother.com
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Tanaka |
Organization
Saint Mother Clinic
Division name
Medical office
Zip code
807-0825
Address
4-9-12 Orio Yahatanishiku, Kitakyusyu Fukuoka, Japan
TEL
093-601-2000
Homepage URL
incho@stmother.com
Sponsor or person
Institute
Saint Mother Clinic
Institute
Department
Personal name
Funding Source
Organization
Saint Mother Clinic
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
Saint Mother Clinic Institutional Review Board
Address
4-9-12 Orio Yahatanishiku, Kitakyusyu Fukuoka, Japan
Tel
0936916004
soumu@stmother.com
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
| 2021 | Year | 08 | Month | 12 | 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
| 2017 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | 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 | 08 | Month | 12 | Day |
Last modified on
| 2021 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051573
