UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of infertility treatment outcomes in patients with premature ovarian insufficiency
Acronym	Investigation of infertility treatment outcomes in patients with premature ovarian insufficiency
Scientific Title	Investigation of infertility treatment outcomes in patients with premature ovarian insufficiency
Scientific Title:Acronym	Investigation of infertility treatment outcomes in patients with premature ovarian insufficiency
Region	Japan

Condition
Condition	Premature ovarian insufficiency
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In assisted reproductive medicine, anti-mullerian hormone (AMH) is widely used as an indicator of ovarian reserve. Although a woman's age is the most important factor affecting fertility outcomes, there have been reports suggesting a correlation with AMH levels in cases of premature ovarian insufficiency(POI). The purpose of this study is to estimate the factors that contribute to the failure to achieve pregnancy in patients with POI by accumulating cases of POI and comparing the results of infertility treatment according to the cause of the POI.
Basic objectives2	Others
Basic objectives -Others	The study design is a retrospective multi-institutional, observational study, in which data will be collected on patients who underwent their first IVF/ICSI procedure between January 1, 2021 and December 31, 2021, and who had AMH less than 1.1 ng/mL.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Clinical pregnancy rate per IVF/ICSI treatment cycle by cause of POI
Key secondary outcomes	Type of fertility drugs, dosage, number of eggs retrieved, number of fertilized eggs, number of embryos transferred, embryo grade, production rate

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
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Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	40 years-old >=
Gender	Female
Key inclusion criteria	1) Patients who started their first IVF/ICSI treatment cycle between January 1, 2021 and December 31, 2021.(The start date of the treatment cycle is the start date of regulated ovarian stimulation, or the start date of menstruation in the case of natural cycles.) 2) Patients whose AMH concentration is less than 1.1 ng/mL within 6 months prior to IVF/ICSI treatment.
Key exclusion criteria	Patients who are deemed inappropriate for inclusion in the program by a physician's judgment
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Akira Middle name Last name Iwase
Organization	Gunma university hospital
Division name	Department of Obstetrics & Gynecology
Zip code	371-8511
Address	3-39-15 Showa-machi, Maebashi, Gunma
TEL	027-220-8429
Email	akiwase@gunma-u.ac.jp

Public contact
Name of contact person	1st name Akira Middle name Last name Iwase
Organization	Department of Gunma university hospital
Division name	Obstetrics & Gynecology
Zip code	371-8511
Address	3-39-15 Showa-machi, Maebashi, Gunma
TEL	027-220-8429
Homepage URL
Email	akiwase@gunma-u.ac.jp

Sponsor
Institute	Gunma university hospital
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Akita University Graduate School of Medicine ,Department of Obstetrics and Gynecology Asada Ladies Clinic Kansai Medical University Hospital, Department of Obstetrics and Gynecology Keio University School of Medicine ,Department of Obstetrics and Gynecology Saitama Medical School Hospital ,Department of Obstetrics and Gynecology Saitama Medical School General Medical Center ,Department of Obstetrics and Gynecology Jichi Medical University ,Department of Obstetrics and Gynecology Shimane University School of Medicine Center for Comprehensive Perinatal Maternal and Child Health Care Sugiyama Obstetrics and Gynecology Clinic St. Marianna University School of Medicine ,Department of Obstetrics and Gynecology Tokyo Medical University ,Department of Obstetrics and Gynecology The University of Tokyo Hospital ,Department of Women's Medicine and Surgery Toho University Medical Center Omori Hospital ,Department of Obstetrics and Gynecology Tokushima University Hospital ,Department of Obstetrics and Gynecology Nagasaki University Hospital ,Department of Obstetrics and Gynecology Hyogo University of Medical Science ,Department of Obstetrics and Gynecology
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Gunma university
Address	3-39-15 Showa-machi, Maebashi, Gunma
Tel	027-220-8763
Email	hitotaisho-ciru@ml.gunma-u.ac.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

Other administrative information
Date of disclosure of the study information	2022 Year 12 Month 05 Day

Related information
URL releasing protocol	https://ciru.dept.showa.gunma-u.ac.jp/guidance/storage-sample/pdf/IRB2022-034.pdf
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	Enrolling by invitation
Date of protocol fixation	2022 Year 09 Month 15 Day
Date of IRB	2022 Year 09 Month 30 Day
Anticipated trial start date	2022 Year 11 Month 01 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	https://ciru.dept.showa.gunma-u.ac.jp/guidance/storage-sample/pdf/IRB2022-034.pdf

Management information
Registered date	2022 Year 12 Month 02 Day
Last modified on	2022 Year 12 Month 02 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056563