UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016992
Receipt number R000019631
Scientific Title Double-blinded randomized controlled trial to evaluate the effect of dietary supplements, Propolis, Royal jelly and resveratrol for infertility treatment of aging women
Date of disclosure of the study information 2015/03/31
Last modified on 2016/10/11 15:34:38

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Basic information

Public title

Double-blinded randomized controlled trial to evaluate the effect of dietary supplements, Propolis, Royal jelly and resveratrol for infertility treatment of aging women

Acronym

Double-blinded RCT of Propolis, Royal jelly and resveratrol for infertility treatment of aging women

Scientific Title

Double-blinded randomized controlled trial to evaluate the effect of dietary supplements, Propolis, Royal jelly and resveratrol for infertility treatment of aging women

Scientific Title:Acronym

Double-blinded RCT of Propolis, Royal jelly and resveratrol for infertility treatment of aging women

Region

Japan


Condition

Condition

Infertility patients with aging undergoing in vitro fertilization-embryo transfer

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In Japan, patients with aging keep to increase due to a trend towards late marriage. Although the success rate for pregnancy in young patients is 26% under IVF-ET program, it decreases with aging, and declines to be only 6.3% in patients over 38 years of age. This low pregnancy rate in aging patients is caused by a decline of oocyte quality. Thus, it is important to improve the outcome of infertility treatment through increase the oocyte quality in patients with aging. In this study, we focus on commercially available dietary supplements, such as Propolis and Royal jelly that poses ant-aging actions. We sought to determine whether these dietary supplements could increase the oocyte quality in patients over 38 years of age undergoing IVF-ET program.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Using Veeck criteria for the classification of embryos with their morphology that reflect the oocyte quality, we score the quality of day 2 or 3 embryo obtained under IVF cycles during 6 months of the dietary supplement treatment and compare their values with those in placebo controls.

Key secondary outcomes

We compare the proportions of fertilization (fertilized oocytes/retrieved oocytes, pregnancy (pregnant cycles/embryo transfer cycles), abortion (abortion cycles/pregnant cycles) between dietary supplement treatment and placebo groups. We also compare the concentration of makers for oxdative stress and immune-related factors (inflammatory cytokines and auto-antibodies).


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Duration of ingestion: 6 months
Propolis or placebo: 2 tablets after every meal, 3 times a day
Combined therapy: one FSH/hMG injection (150-300 IU) per day until maturation of follicles, one hCG injection (5,000-10,000 IU) per day when follicles mature
Perform several IVF during 6 months including at the end of 6 months ingestion
Perform blood test, follicular fluid test, and cytological analyses in ovarian cells at the time of oocyte retrieval

Interventions/Control_2

Duration of ingestion: 6 months
Royal jelly or placebo: 2 tablets after every meal, 3 times a day
Combined therapy: one FSH/hMG injection (150-300 IU) per day until maturation of follicles, one hCG injection (5,000-10,000 IU) per day when follicles mature
Perform several IVF during 6 months including at the end of 6 months ingestion
Perform blood test, follicular fluid test, and cytological analyses in ovarian cells at the time of oocyte retrieval

Interventions/Control_3

Duration of ingestion: 6 months
Resveratrol or placebo: 1 tablets after morning meal, 1 time a day
Combined therapy: one FSH/hMG injection (150-300 IU) per day until maturation of follicles, one hCG injection (5,000-10,000 IU) per day when follicles mature
Perform several IVF during 6 months including at the end of 6 months ingestion
Perform blood test, follicular fluid test, and cytological analyses in ovarian cells at the time of oocyte retrieval

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

38 years-old <=

Age-upper limit

48 years-old >

Gender

Female

Key inclusion criteria

1) Infertile female patients undergoing IVF-ET treatment
2) >=38 years of age and < 48 years of age when we receive written informed consent from the patients
3) Out patients in our hospital
4) Patients with written informed consent after explanation of this clinical study

Key exclusion criteria

1) Patients with ingestion of other dietary supplements within one menstrual cycle prior to the initiation of study
2) Patients who decided to be unsuitable for this study by physicians

Target sample size

384


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuhiro Kawamura

Organization

St. Marianna University School of Medicine

Division name

Obstetrics and Gynecology

Zip code


Address

2-16-1 Sugao, Miyamaeku, Kawasakishi, Kanagawa

TEL

044-977-8111(ext.3332)

Email

kazuhironanami@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Kazuhiro Kawamura

Organization

St. Marianna University School of Medicine

Division name

Obstetrics and Gynecology

Zip code


Address

2-16-1 Sugao, Miyamaeku, Kawasakishi, Kanagawa

TEL

044-977-8111(ext.3332)

Homepage URL


Email

kazuhironanami@gmail.com


Sponsor or person

Institute

St. Marianna University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Yamada Research Grant

Organization

Division

Category of Funding Organization

Non profit foundation

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



Other administrative information

Date of disclosure of the study information

2015 Year 03 Month 31 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

Open public recruiting

Date of protocol fixation

2014 Year 07 Month 17 Day

Date of IRB


Anticipated trial start date

2015 Year 04 Month 14 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 03 Month 31 Day

Last modified on

2016 Year 10 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019631


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name