The Effect of RECO-18 on Infertile Women Undergoing in Vitro Fertilization-embryo Transfer

Sun Yat-sen University

Status: Unknown

Conditions: Fertility Disorders; Infertility, Female

Treatments: Dietary Supplement: RECO-18; Dietary Supplement: Multi-vitamins

Study type: Interventional

Funder types: Other

Identifiers

NCT05412147

2022-KY-063

Details and patient eligibility

About

How to improve the fertility of infertile women has become a hot topic in the field of assisted reproduction. Animal experiment has shown that RECO-18 significantly improved the female fertility in mice, and the specific mechanism was related to reducing follicular atresia, promoting follicle development and improving oocyte quality. Therefore the investigators aim to conduct a pilot study to explore the effect of RECO-18 in infertile women undergoing assisted reproduction treatment. This study is a prospective, randomized, controlled clinical study. The treatment group takes RECO-18 while the control group takes the multi-vitamins. The primary indicator is the ongoing pregnancy rate at 12 weeks' gestation; the secondary indicators are the number of oocytes retrieved, the normal fertilization rate and the rate of high quality embryos, implantation rate, clinical pregnancy rate, and early miscarriage rate.

Full description

Mitochondrial function is closely related to oocyte quality in female. Deficiency of multiple micronutrients is common in infertile women, and supplementation with multiple micronutrients has antioxidant effects to reduce the damage of oxidative stress to fertility, and helps to improve the outcomes of assisted reproductive treatment. RECO-18 is a functional food containing a variety of plant extracts and enzymatic soy phospholipids. In in vivo and in vitro senescent models, the investigators found RECO-18 to improve oocyte quality mainly by regulating the mitochondrial apoptosis pathway. The investigators also found RECO-18 significantly improved the fertility of mice, and the specific mechanism was related to reducing follicular atresia, promoting follicle development and improving oocyte quality. Based on the animal experiments, the investigators intend to conduct a clinical trial to explore whether RECO-18 plays a role in improving oocyte and embryo quality and pregnancy outcomes in infertile women undergoing in vitro fertilization-embryo transfer.

Enrollment: 80 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• female, 20 to 40 years old
• the 1st or 2nd cycle of IVF/ICSI treatment
• BMI≤30Kg/m2
• with bilateral ovaries
• be eligible for IVF/ICSI treatment

Exclusion criteria

• Repeated implantation failures (with previous 3 or more IVF/ICSI failures)
• moderate to severe endometriosis
• untreated hydrosalpinx
• untreated endometrial disease
• contraindications for assisted reproductive techniques or gestation
• a history of ovarian surgery
• expected poor ovarian response (POR) or previous POR
• polycystic ovarian syndrome
• participants in clinical trials of other drugs within one month prior to enrollment; • hypersensitivity to follicle-stimulating hormone α, FSH, human menopausal gonadotropin, LH or excipients
• uncontrolled endocrine diseases (such as hyperthyroidism, hypothyroidism, adrenal gland disease, obesity, etc.)
• percutaneous epididymal sperm aspiration or testicular sperm aspiration

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Control group

Active Comparator group

Description:

The control group takes the multi-vitamins (Elevit, Bayer S.A.) with the dosage of one tablet per day on the 1st to 5th day of menstruation, then perform ovulation induction on the second menstrual cycle, and continue to take multi-vitamins until the day of oocyte retrieval.

Treatment:

Dietary Supplement: Multi-vitamins

Treatment group

Experimental group

Description:

The treatment group begins to take Reco-18 on the 1st to 5th day of menstruation with a dosage of 4 pills per day for the whole menstrual cycle, then perform ovulation induction on the second menstrual cycle, and continue to take Reco-18 until the day of oocyte retrieval.

Treatment:

Dietary Supplement: RECO-18