Clinical trial NCT05412147: The Effect of RECO-18 on Infertile Women Undergoing in Vitro Fertilization-embryo Transfer
Official title: A Pilot Study of the Effect of RECO-18 Containing Natural Plant Extracts on Infertile Women Undergoing in Vitro Fertilization-embryo Transfer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fertility Disorders
Infertility, Female
Keywords: pregnancy rate
in vitro fertilization-embryo transfer
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2022-06-09
Enrollment: 80
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Ongoing pregnancy rate at 12 weeks' gestation
timeFrame: At 12 weeks' gestation
Secondary outcomes:
measure: Number of retrieved oocytes
timeFrame: Two weeks after oocyte retrieval
Other outcomes:
measure: The normal fertilization rate
timeFrame: Two weeks after oocyte retrieval
measure: The rate of high quality embryos
timeFrame: Two weeks after oocyte retrieval
measure: Implantation rate
timeFrame: Four to five weeks after embryo transfer
measure: Clinical pregnancy rate
timeFrame: Four to five weeks after embryo transfer
measure: early miscarriage rate
timeFrame: At 12 weeks' gestation
Locations:
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Dongzi Yang, doctor
role: STUDY_DIRECTOR
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Hui Chen, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Ruiqi Li, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Xiaoli Chen, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Lin Li, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Ping Pan, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Jia Huang, doctor
role: PRINCIPAL_INVESTIGATOR
References: