UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000063413
Receipt number R000071506
Scientific Title Multicenter prospective observational study on the impact of an individualized probiotic administration strategy, based on vaginal culture screening, on pregnancy outcomes after frozen-thawed embryo transfer
Date of disclosure of the study information 2026/10/27
Last modified on 2026/10/26 07:22:37

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Basic information

Public title

Study on probiotic use guided by vaginal bacterial testing and pregnancy outcomes after frozen embryo transfer

Acronym

Study on probiotic use guided by vaginal bacterial testing and pregnancy outcomes after frozen embryo transfer

Scientific Title

Multicenter prospective observational study on the impact of an individualized probiotic administration strategy, based on vaginal culture screening, on pregnancy outcomes after frozen-thawed embryo transfer

Scientific Title:Acronym

Vaginal Culture-Based Individualized Probiotic Strategy and FET Outcome Study

Region

Japan


Condition

Condition

Infertility (patients scheduled for frozen-thawed embryo transfer)

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate, in a prospective manner, the impact of an individualized probiotic administration strategy based on vaginal culture screening (offering the option not to use probiotics in patients with a normal vaginal microenvironment, while recommending its use in patients with an abnormal vaginal microenvironment) on pregnancy outcomes after frozen-thawed embryo transfer (FET).

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Clinical pregnancy rate (defined by confirmation of gestational sac, assessed by 6 weeks of gestation)

Key secondary outcomes

Initial serum hCG level at 7-10 days after transfer; biochemical pregnancy loss rate; ongoing pregnancy rate (beyond 12 weeks); live birth rate; miscarriage rate; outcomes stratified by Nugent score and vaginal culture species (exploratory); subgroup analysis limited to good-quality embryos, Gardner BB or higher (exploratory)


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


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

18 years-old <=

Age-upper limit


 Not applicable

Gender

Female

Key inclusion criteria

Patients scheduled for FET at Kamiya Ladies Clinic or Kameda IVF Clinic Makuhari; first transfer using a blastocyst-stage embryo (any Gardner grade; second or later transfers excluded); age 18 years or older; no refusal of study participation via the opt-out procedure

Key exclusion criteria

Patients who explicitly refused participation via opt-out; untreated uterine anomalies (e.g., septate or bicornuate uterus); serious systemic disease; vaginal culture screening not performed within 3 months before the transfer cycle

Target sample size

916


Research contact person

Name of lead principal investigator

1st name Hirobumi
Middle name
Last name Kamiya

Organization

Iryo Hojin Shadan Kamiya Ladies Clinic

Division name

Reproductive Medicine

Zip code

0600003

Address

NX Sapporo Bldg 2F, 2-1, Nishi2, Kita3, Chuo-ku, Sapporo, Hokkaido, 0600003, Japan

TEL

011-231-2722

Email

kamiya@fine.ocn.ne.jp


Public contact

Name of contact person

1st name Nanako
Middle name
Last name Iwami

Organization

Iryo Hojin Shadan Kamiya Ladies Clinic

Division name

Reproductive Medicine

Zip code

06000003

Address

NX Sapporo Bldg 2F, 2-1, Nishi2, Kita3, Chuo-ku, Sapporo, Hokkaido, 0600003, Japan

TEL

011-231-2722

Homepage URL


Email

iwami@kamiyaclinic.com


Sponsor or person

Institute

Iryo Hojin Shadan Kamiya Ladies Clinic

Institute

Department

Personal name



Funding Source

Organization

self-funding of research

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Kameda IVF Clinic Makuhari

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Iryo Hojin Shadan Kamiya Ladies Clinic

Address

NX Sapporo Bldg 2F, 2-1, Nishi2, Kita3, Chuo-ku, Sapporo, Hokkaido, 0600003, Japan

Tel

011-231-2722

Email

tozawa@kamiyaclinic.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

2026 Year 10 Month 27 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

Preinitiation

Date of protocol fixation

2026 Year 03 Month 10 Day

Date of IRB

2026 Year 03 Month 14 Day

Anticipated trial start date

2026 Year 10 Month 27 Day

Last follow-up date

2028 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This is an observational study, and no intervention is performed for research purposes. Among patients with a normal vaginal culture (Nugent score 0 to 3 and no pathogens detected), use or non-use of Lactosupple 2 (an intravaginal product) is a routine clinical choice based on patient preference. Investigators neither allocate nor instruct its use. Use is defined as intravaginal administration for 10 days or more within 3 months before the embryo transfer date, and non-use is defined as administration for less than 10 days or none. Status is confirmed from prescription records in the medical chart and by patient interview. Patients with an abnormal vaginal culture (Nugent score 4 or higher, or pathogens detected) are recommended to use the product as part of routine care, and are collected as a secondary reference group. Pregnancy outcomes after frozen-thawed embryo transfer are collected prospectively from medical records.


Management information

Registered date

2026 Year 10 Month 26 Day

Last modified on

2026 Year 10 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071506