Fertility DisordersNCT05412147
The Effect of RECO-18 on Infertile Women Undergoing in Vitro Fertilization-embryo Transfer
A study testing RECO-18 and Multi-vitamins in people with Fertility Disorders and Infertility, Female, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Fertility Disorders, Infertility, Female
- What is being tested?
- RECO-18 and Multi-vitamins
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jul 2022to Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Fertility Disorders, Infertility, Female
- Being tested
- RECO-18, Multi-vitamins
- Keywords
- pregnancy rate, in vitro fertilization-embryo transfer
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RECO-18Dietary supplement
4 pills daily, oral
Multi-vitaminsDietary supplement
one tablet daily, oral
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Multi-vitamins |
| 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. Receives: Dietary Supplement: RECO-18 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate at 12 weeks' gestation
Gestational sac with embryocardia-beat detected on ultrasound at 12 weeks' gestation
Measured: At 12 weeks' gestation
Secondary outcomes (1)
Number of retrieved oocytes
Total number of retrieved oocytes
Measured: Two weeks after oocyte retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study startJul 2022 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility DisordersStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dongzi Yang, doctor, Study director, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityHui Chen, doctor, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRuiqi Li, doctor, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityXiaoli Chen, doctor, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityLin Li, doctor, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityPing Pan, doctor, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityJia Huang, doctor, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05412147
- Sponsor's protocol ID
- 2022-KY-063
- Status last verified
- Apr 2022
- First submitted
- 24 May 2022
- Last updated
- 9 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Effect of RECO-18 Containing Natural Plant Extracts on Infertile Women Undergoing in Vitro Fertilization-embryo Transfer
- ClinicalTrials.gov ID
- NCT05412147
- Acronym / sponsor ID
- 2022-KY-063
- Conditions
- Fertility Disorders, Infertility, Female
- Keywords
- pregnancy rate, in vitro fertilization-embryo transfer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Jul 2022 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 9 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Dietary Supplement: Multi-vitaminsThe 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. |
| Treatment group | Experimental | Dietary Supplement: RECO-18The 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RECO-184 pills daily, oral | Dietary supplement | Treatment group |
| Multi-vitaminsone tablet daily, oral | Dietary supplement | Control group |
Primary outcome
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
1 secondary outcome
Number of retrieved oocytes
Time frame: Two weeks after oocyte retrieval
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dongzi Yang, doctor study director
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Hui Chen, doctor principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Ruiqi Li, doctor principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Questions about this trial
What is this clinical trial studying?
A study testing RECO-18 and Multi-vitamins in people with Fertility Disorders and Infertility, Female, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Li, doctor (13660141860, liyuliyu0922@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing pregnancy rate at 12 weeks' gestation (time frame: At 12 weeks' gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2022.