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

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

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

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

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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