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

Infertility, Female Clinical Trial

Official title:

A Pilot Study of the Effect of RECO-18 Containing Natural Plant Extracts on Infertile Women Undergoing in Vitro Fertilization-embryo Transfer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05412147
• Other study ID #: 2022-KY-063
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2022
• Est. completion date: April 2023

Study information

• Verified date: April 2022
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Yu Li, doctor
• Phone: 13660141860
• Email: liyuliyu0922[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: April 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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 a, 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

Related Conditions & MeSH terms

• Fertility Disorders
• Infertility
• Infertility, Female

Intervention

Dietary Supplement:
• RECO-18
4 pills daily, oral
• Multi-vitamins
one tablet daily, oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The normal fertilization rate	The rate of fertilization with two pronuclear	Two weeks after oocyte retrieval
Other	The rate of high quality embryos	Number of high quality embryos / number of normal fertilized and cleavaged embryos	Two weeks after oocyte retrieval
Other	Implantation rate	Number of gestational sac / number of transferred embryos	Four to five weeks after embryo transfer
Other	Clinical pregnancy rate	Gestational sacs detected on ultrasound four to five weeks after embryo transfer	Four to five weeks after embryo transfer
Other	early miscarriage rate	Misscarriage within 12 weeks' gestation	At 12 weeks' gestation
Primary	Ongoing pregnancy rate at 12 weeks' gestation	Gestational sac with embryocardia-beat detected on ultrasound at 12 weeks' gestation	At 12 weeks' gestation
Secondary	Number of retrieved oocytes	Total number of retrieved oocytes	Two weeks after oocyte retrieval