UMIN-CTR Clinical Trial

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	Obsterics 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
Email	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
Email	incho@stmother.com

Sponsor
Institute	Saint Mother Clinic
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051573