UMIN-CTR Clinical Trial

Basic information
Public title	Characteristics of controlled ovarian stimulation by follitropin delta compared with follitropin alpha
Acronym	Controlled ovarian stimulation by follitropin delta
Scientific Title	Characteristics of controlled ovarian stimulation by follitropin delta compared with follitropin alpha
Scientific Title:Acronym	Controlled ovarian stimulation by follitropin delta
Region	Japan

Condition
Condition	Infertility
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Comparison of clinical performance and follicle development between follitropin delta and follitropin alfa
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Clinical pregnancy rate, follicular growth diameter
Key secondary outcomes

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	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Controlled ovarian stimulation with follitropin delta
Interventions/Control_2	Controlled ovarian stimulation with follitropin alfa
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	25 years-old <=
Age-upper limit	42 years-old >=
Gender	Female
Key inclusion criteria	Infertility patients receiving assisted reproductive technology
Key exclusion criteria	nothing
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Masato Middle name Last name Kobanawa
Organization	Kobanawa Clinic
Division name	Gynecology
Zip code	311-3435
Address	169-3 Tagiya,Omitama-shi,Ibaraki,Japan
TEL	0299-58-3185
Email	masato.kobanawa@gmail.com

Public contact
Name of contact person	1st name Masato Middle name Last name Kobanawa
Organization	Kobanawa Clinic
Division name	Gynecology
Zip code	311-3435
Address	169-3 Tagiya,Omitama-shi,Ibaraki,Japan
TEL	0299-58-3185
Homepage URL
Email	masato.kobanawa@gmail.com

Sponsor
Institute	Kobanawa Clinic
Institute
Department

Funding Source
Organization	nothing
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Ethics committee of Kobanawa Clinic
Address	169-3 Tagiya,Omitama-shi,Ibaraki,Japan
Tel	0299-58-3185
Email	masato.kobanawa@gmail.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	2022 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	56
Results	The fertilization rate, the good blastocyst rate and clinical pregnancy rates were no significant difference. As a characteristic of follitropin delta COS, follicle development was significantly slow.
Results date posted	2022 Year 11 Month 30 Day
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	Main results already published
Date of protocol fixation	2021 Year 09 Month 17 Day
Date of IRB	2022 Year 01 Month 18 Day
Anticipated trial start date	2021 Year 10 Month 01 Day
Last follow-up date	2023 Year 01 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 11 Month 30 Day
Last modified on	2022 Year 11 Month 30 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056543