- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05412147
The Effect of RECO-18 on Infertile Women Undergoing in Vitro Fertilization-embryo Transfer
June 6, 2022 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
A Pilot Study of the Effect of RECO-18 Containing Natural Plant Extracts on Infertile Women Undergoing in Vitro Fertilization-embryo Transfer
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yu Li, doctor
- Phone Number: 13660141860
- Email: liyuliyu0922@163.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 38 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control group
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.
|
one tablet daily, oral
|
Experimental: Treatment group
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.
|
4 pills daily, oral
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ongoing pregnancy rate at 12 weeks' gestation
Time Frame: 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
Time Frame: Two weeks after oocyte retrieval
|
Total number of retrieved oocytes
|
Two weeks after oocyte retrieval
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The normal fertilization rate
Time Frame: Two weeks after oocyte retrieval
|
The rate of fertilization with two pronuclear
|
Two weeks after oocyte retrieval
|
The rate of high quality embryos
Time Frame: Two weeks after oocyte retrieval
|
Number of high quality embryos / number of normal fertilized and cleavaged embryos
|
Two weeks after oocyte retrieval
|
Implantation rate
Time Frame: Four to five weeks after embryo transfer
|
Number of gestational sac / number of transferred embryos
|
Four to five weeks after embryo transfer
|
Clinical pregnancy rate
Time Frame: Four to five weeks after embryo transfer
|
Gestational sacs detected on ultrasound four to five weeks after embryo transfer
|
Four to five weeks after embryo transfer
|
early miscarriage rate
Time Frame: At 12 weeks' gestation
|
Misscarriage within 12 weeks' gestation
|
At 12 weeks' gestation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Dongzi Yang, doctor, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Principal Investigator: Hui Chen, doctor, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Principal Investigator: 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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
July 1, 2022
Primary Completion (Anticipated)
April 1, 2023
Study Completion (Anticipated)
April 1, 2023
Study Registration Dates
First Submitted
May 24, 2022
First Submitted That Met QC Criteria
June 6, 2022
First Posted (Actual)
June 9, 2022
Study Record Updates
Last Update Posted (Actual)
June 9, 2022
Last Update Submitted That Met QC Criteria
June 6, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-KY-063
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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