Unique ID issued by UMIN | UMIN000016992 |
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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 |
Double-blinded randomized controlled trial to evaluate the effect of dietary supplements, Propolis, Royal jelly and resveratrol for infertility treatment of aging women
Double-blinded RCT of Propolis, Royal jelly and resveratrol for infertility treatment of aging women
Double-blinded randomized controlled trial to evaluate the effect of dietary supplements, Propolis, Royal jelly and resveratrol for infertility treatment of aging women
Double-blinded RCT of Propolis, Royal jelly and resveratrol for infertility treatment of aging women
Japan |
Infertility patients with aging undergoing in vitro fertilization-embryo transfer
Obstetrics and Gynecology |
Others
NO
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.
Efficacy
Confirmatory
Explanatory
Not applicable
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.
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).
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
YES
Central registration
3
Treatment
Food |
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
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
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
38 | years-old | <= |
48 | years-old | > |
Female
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
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
384
1st name | |
Middle name | |
Last name | Kazuhiro Kawamura |
St. Marianna University School of Medicine
Obstetrics and Gynecology
2-16-1 Sugao, Miyamaeku, Kawasakishi, Kanagawa
044-977-8111(ext.3332)
kazuhironanami@gmail.com
1st name | |
Middle name | |
Last name | Kazuhiro Kawamura |
St. Marianna University School of Medicine
Obstetrics and Gynecology
2-16-1 Sugao, Miyamaeku, Kawasakishi, Kanagawa
044-977-8111(ext.3332)
kazuhironanami@gmail.com
St. Marianna University School of Medicine
Yamada Research Grant
Non profit foundation
NO
2015 | Year | 03 | Month | 31 | Day |
Unpublished
Open public recruiting
2014 | Year | 07 | Month | 17 | Day |
2015 | Year | 04 | Month | 14 | Day |
2015 | Year | 03 | Month | 31 | Day |
2016 | Year | 10 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019631
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