UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Double-blinded randomized controlled trial to evaluate the effect of dietary supplements, Propolis, Royal jelly and resveratrol for infertility treatment of aging women
Title of the study (Brief title)	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	Obsterics 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	Kazuhiro Kawamura
Organization	St. Marianna University School of Medicine
Division name	Obstetrics and Gynecology
Address	2-16-1 Sugao, Miyamaeku, Kawasakishi, Kanagawa
TEL	044-977-8111(ext.3332)
Email	kazuhironanami@gmail.com

Public contact
Name of contact person	Kazuhiro Kawamura
Organization	St. Marianna University School of Medicine
Division name	Obstetrics and Gynecology
Address	2-16-1 Sugao, Miyamaeku, Kawasakishi, Kanagawa
TEL	044-977-8111(ext.3332)
Homepage URL
Email	kazuhironanami@gmail.com

Sponsor
Institute	St. Marianna University School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 07 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019631