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

NCT05412147 | Unknown

• 1 other identifier: 2022-KY-063
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fertility Disorders; Infertility, Female

Keywords

pregnancy rate; in vitro fertilization-embryo transfer

Outcome Measures

Primary Outcomes (1)

• Ongoing pregnancy rate at 12 weeks' gestation

  Gestational sac with embryocardia-beat detected on ultrasound at 12 weeks' gestation

  At 12 weeks' gestation

Secondary Outcomes (1)

• Number of retrieved oocytes

  Two weeks after oocyte retrieval

Other Outcomes (5)

• The normal fertilization rate

  Two weeks after oocyte retrieval

• The rate of high quality embryos

  Two weeks after oocyte retrieval

• Implantation rate

  Four to five weeks after embryo transfer

Study Arms (2)

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.

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.

Dietary Supplement: RECO-18

Interventions

RECO-18 DIETARY_SUPPLEMENT

4 pills daily, oral

Treatment group

Multi-vitamins DIETARY_SUPPLEMENT

one tablet daily, oral

Control group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Officials

• 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

• 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

Central Study Contacts

Yu Li, doctor

CONTACT

13660141860; liyuliyu0922@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: June 9, 2022
• Study Start: July 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: June 9, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share