Fertility Disorders, Infertility, Female
Conditions
Keywords
pregnancy rate, in vitro fertilization-embryo transfer
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.
Interventions
DIETARY_SUPPLEMENTRECO-18
4 pills daily, oral
DIETARY_SUPPLEMENTMulti-vitamins
one tablet daily, oral
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ongoing pregnancy rate at 12 weeks' gestation | At 12 weeks' gestation | Gestational sac with embryocardia-beat detected on ultrasound at 12 weeks' gestation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of retrieved oocytes | Two weeks after oocyte retrieval | Total number of retrieved oocytes |
Other
| Measure | Time frame | Description |
|---|---|---|
| The rate of high quality embryos | Two weeks after oocyte retrieval | Number of high quality embryos / number of normal fertilized and cleavaged embryos |
| Clinical pregnancy rate | Four to five weeks after embryo transfer | Gestational sacs detected on ultrasound four to five weeks after embryo transfer |
| early miscarriage rate | At 12 weeks' gestation | Misscarriage within 12 weeks' gestation |
| Implantation rate | Four to five weeks after embryo transfer | Number of gestational sac / number of transferred embryos |
| The normal fertilization rate | Two weeks after oocyte retrieval | The rate of fertilization with two pronuclear |
Contacts
Primary ContactYu Li, doctor
Outcome results
None listed