ART-Pterostilbene

JRCT ID: jRCTs031220638

Registered date:14/02/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Infertility
• Date of first enrollment: 22/10/2023
• Target sample size: 460
• Study type: Interventional
• Intervention(s): Pterostilbene or placebo is administered daily for a period of 6 to 8 weeks (1 capsule/tablet twice daily after breakfast and dinner) starting 1 week before the start of menstruation.

Outcome(s)

• Primary Outcome: Percentage of embryos reaching the blastocyst stage on Day 5 after fertilization (number of blastocysts/ number of normal fertilized oocytes)

Secondary Outcome

Oocyte maturation rate (number of mature oocytes/number of retrieved oocytes)
Fertilization rate (number of normal fertilized oocytes/number of retrieved oocytes)
Clinical pregnancy rate (frequency of detectable gestational sac under ultrasound analysis/frequency of embryo transfer)
Miscarriage rate (frequency of miscarriage/frequency of embryo transfer)
Pterostilbene concentration (blood and follicular fluid)

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: <= 45age old
• Gender: Female

Include criteria

(1) Infertile female patients undergoing in vitro fertilization.
(2) Patients aged 40 years or older at the time of informed consent .
(3) Patients attending the outpatient clinic of a collaborating study site.
(4) Patients who have the ability to consent and are able to obtain written consent by their own volition.
(5) Patients judged by the investigator (co-investigator) to be able to appropriately evaluate the efficacy and safety of this study with considering the inclusion and exclusion criteria.

Exclude criteria

(1) Patients taking supplements other than vitamin D, folic acid, or iron within one menstrual cycle before the start of the study.
(2) Patients where the possible causes of infertility include diabetes mellitus, polycystic ovary, or a partner with severe spermatogenic dysfunction.
(3) Patients who have received reproductively toxic chemotherapy or radiotherapy.
(4) Patients with recurrent implantation failure.
(5) Unmarried patients who wish to freeze their eggs.
(6) Patients who have participated in this study in the past.
(7) Patients with an allergy to resveratrols and dextrin (starch).
(8) Patients with a menstrual cycle of 3 weeks or less or 5 weeks or more.
(9)Patients who are considered inappropriate for participation in the study by the investigator or subinvestigator.

Related Information

• Primary Sponsor: Kawamura Kazuhiro
• Secondary Sponsor: PARTNERS Co., Ltd.