UMIN-CTR Clinical Trial

Basic information
Public title	Lactoferrin supplementation for repeated implantation failure patients with uterine/vaginal dysbiosis
Acronym	Lactoferrin supplementation for repeated implantation failure patients with uterine/vaginal dysbiosis
Scientific Title	Lactoferrin supplementation for repeated implantation failure patients with uterine/vaginal dysbiosis
Scientific Title:Acronym	Lactoferrin supplementation for repeated implantation failure patients with uterine/vaginal dysbiosis
Region	Japan

Condition
Condition	Repeated implantation failure
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to investigate if oral supplementation of 700mg/day lactoferrin contributes to (i) rise its concentration in circulating blood, endometrial fluid, and vaginal secretion, (ii) correct the dysbiosis in the uterine/vaginal cavity in patients undergoing repeated implantation failure, and (iii) improve the pregnancy outcome in these patients.
Basic objectives2	PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	(i) Measurement of lactoferrin concentration in circulating blood, endometrial fluid, and vaginal secretion (ii) Microbiota analysis of endometrial fluid, and vaginal secretion (iii) Reproductive outcome
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food Maneuver Other
Interventions/Control_1	Oral supplementation of 700mg/day lactoferrin for 28 days or more for infertile patients with a history of repeated implantation failure and collection of circulating blood, endometrial fluid, and vaginal secretion before and after the intervention
Interventions/Control_2	Collection of circulating blood, endometrial fluid, and vaginal secretion from infertile patients undergoing first embryo transfer attempt
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	20 years-old <=
Age-upper limit	45 years-old >=
Gender	Female
Key inclusion criteria	Infertile women requiring artificial reproductive technology
Key exclusion criteria	Infertile women lacking anatomical uterus and/or vagina
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Kotaro Middle name Last name Kitaya
Organization	Reproduction Clinic Osaka
Division name	IVF Center
Zip code	5300011
Address	Grand Front Osaka, Tower-A 15F, 4-20 Oofuka-cho, Kita-ku, Osaka, 530-0011, Japan
TEL	0661363344
Email	kitaya@koto.kpu-m.ac.jp

Public contact
Name of contact person	1st name Kotaro Middle name Last name Kitaya
Organization	Reproduction Clinic Osaka
Division name	IVF Center
Zip code	5300011
Address	Grand Front Osaka, Tower-A 15F, 4-20 Oofuka-cho, Kita-ku, Osaka, 530-0011, Japan
TEL	0661363344
Homepage URL
Email	kitaya@koto.kpu-m.ac.jp

Sponsor
Institute	Reproduction Clinic Osaka
Institute
Department

Funding Source
Organization	Reproduction Clinic Osaka
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	Reproduction Clinic Osaka
Address	Grand Front Osaka, Tower-A 15F, 4-20 Oofuka-cho, Kita-ku, Osaka, 530-0011, Japan
Tel	0661363344
Email	kitaya@koto.kpu-m.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	2019 Year 06 Month 07 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://pubmed.ncbi.nlm.nih.gov/35987819/
Number of participants that the trial has enrolled	172
Results	While CE was more prevalent (OR 2.41, 95% CI 1.02-5.63, p = 0.042) in the RIF group (29.1%, n = 117) than in the non-RIF group (14.5%, n = 55), The NLDM rate was similar between the two groups Lactoferrin supplementation improved NLDM in 43.2% of RIF women (n = 37). Within the RIF group, the live birth rate in the subsequent cycles was higher (OR 10.67, 95% CI 1.03 - 110.0, p = 0.046) in women with improved microbiota (57.1%, n = 14) than in those with unimproved microbiota (11.1%, n = 9).
Results date posted	2022 Year 09 Month 15 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events	None
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2019 Year 04 Month 30 Day
Date of IRB	2019 Year 05 Month 31 Day
Anticipated trial start date	2019 Year 06 Month 07 Day
Last follow-up date	2022 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	2019 Year 06 Month 07 Day
Last modified on	2022 Year 09 Month 15 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042082