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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Fertility Disorders, Infertility, Female

Intervention / Treatment
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* Dietary Supplement: RECO-18
* Dietary Supplement: Multi-vitamins


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>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. | Dietary Supplement: Multi-vitamins<br>* one tablet daily, oral<br>|
| Experimental: Treatment group<br>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. | Dietary Supplement: RECO-18<br>* 4 pills daily, oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing pregnancy rate at 12 weeks' gestation | Gestational sac with embryocardia-beat detected on ultrasound at 12 weeks' gestation | At 12 weeks' gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of retrieved oocytes | Total number of retrieved oocytes | Two weeks after oocyte retrieval | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregnancy rate, in vitro fertilization-embryo transfer