UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of treatment with progesterone in controlled ovarian stimulation for patients undergoing IVF/ICSI cycles to prevent ovulation: a randomized clinical trial
Acronym	MPA study
Scientific Title	Evaluation of treatment with progesterone in controlled ovarian stimulation for patients undergoing IVF/ICSI cycles to prevent ovulation: a randomized clinical trial
Scientific Title:Acronym	MPA study
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the effectiveness of medroxyprogesterone acetate (MPA) is equal to GnRH antagonist for preventing lutenizing hormone surges in controlled ovarian hyperstimulation cycles and to investigate the clinical outcomes and endocrinological characteristics during its usage.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the incidence of ovulation before oocyte retrieval
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
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	10mg of MPA (medroxyprogesterone) oral intake daily for 10 days
Interventions/Control_2	0.25mg of GnRHantagonist injection subcutaneously daily for 1 to 3 days
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	Not applicable
Age-upper limit	43 years-old >
Gender	Female
Key inclusion criteria	Patients who will undergo IVF treatments by controlled ovarian hyperstimulation with AMH level 1 ng/ml or higher
Key exclusion criteria	1 Patients with ovulatory disturbance caused by reduced hypothalamic or pituitary activity 2 Patients who can not use GnRH-agonist nasal spray for triggering final oocyte maturation
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Eri Okamoto
Organization	Hanabusa Womens' clinic
Division name	Docter
Zip code
Address	7F 1-1-2 Sannomiya-cho Chuo-ku Kobe city Hyogo
TEL	078-392-8723
Email	okamoto@hanabusaclinic.com

Public contact
Name of contact person	1st name Middle name Last name Eri Okamoto
Organization	Hanabusa Womens' clinic
Division name	Docter
Zip code
Address	7F 1-1-2 Sannomiya-cho Chuo-ku Kobe city Hyogo
TEL	078-392-8723
Homepage URL
Email	okamoto@hanabusaclinic.com

Sponsor
Institute	Hanabusa Womens' clinic
Institute
Department

Funding Source
Organization	Hanabusa Womens' 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
Address
Tel
Email

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	英ウィメンズクリニック

Other administrative information
Date of disclosure of the study information	2019 Year 01 Month 07 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	Terminated
Date of protocol fixation	2018 Year 12 Month 27 Day
Date of IRB	2019 Year 01 Month 07 Day
Anticipated trial start date	2019 Year 01 Month 07 Day
Last follow-up date	2019 Year 01 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 01 Month 07 Day
Last modified on	2022 Year 01 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040024