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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | 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. |
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| Treatment group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RECO-18 | Dietary Supplement | 4 pills daily, oral |
| |
| Multi-vitamins |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of retrieved oocytes | Total number of retrieved oocytes | Two weeks after oocyte retrieval |
| Measure | Description | Time Frame |
|---|---|---|
| The normal fertilization rate | The rate of fertilization with two pronuclear | Two weeks after oocyte retrieval |
| The rate of high quality embryos | Number of high quality embryos / number of normal fertilized and cleavaged embryos |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu Li, doctor | Contact | 13660141860 | liyuliyu0922@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Dongzi Yang, doctor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Study Director |
| Hui Chen, doctor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Principal Investigator |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 20, 2022 | May 31, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 20, 2022 | May 31, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Dietary Supplement |
one tablet daily, oral |
|
| Two weeks after oocyte retrieval |
| Implantation rate | Number of gestational sac / number of transferred embryos | Four to five weeks after embryo transfer |
| Clinical pregnancy rate | Gestational sacs detected on ultrasound four to five weeks after embryo transfer | Four to five weeks after embryo transfer |
| early miscarriage rate | Misscarriage within 12 weeks' gestation | At 12 weeks' gestation |
| Ruiqi Li, doctor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Principal Investigator |
| Xiaoli Chen, doctor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Principal Investigator |
| Lin Li, doctor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Principal Investigator |
| Ping Pan, doctor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Principal Investigator |
| Jia Huang, doctor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Principal Investigator |
| D000091662 | Genital Diseases |
| D007246 | Infertility |