Effect of Guiluxian on the outcome of in vitro fertilization and embryo transfer in elderly women with low prognosis: a multicenter, double-blind, randomized, placebo-controlled trial

Phase 1

Recruiting

• Conditions: Infertile patients with advanced age and low prognosis

• Registration Number: ITMCTR1900002843
• Lead Sponsor: Affiliated Hospital of Shandong University of traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

In this study, we will recruit subjects who are 35 and 42 years old, meet the diagnostic criteria of western medicine infertility, insufficient ovarian reserve parameters (AFC < 5, AMH < 1.1ng/mL, FSH >= 10IU / L), poor ovarian response (i.e. oocytes obtained after standard ovarian stimulation <= 3), and meet the indications of IVF-ET.

Exclusion Criteria

(1) BMI >= 25Kg/m2;
(2) those suffering from genetic diseases that are not suitable for reproduction as stipulated in the law on maternal and child health care;
(3) severe endometriosis, adenomyosis, and immune infertility;
(4) untreated hydrosalpinx;
(5) congenital or acquired abnormal uterine development and other serious reproductive organ malformations;
(6) complicated with reproductive system tumor, thyroid dysfunction, hyperprolactinemia and other endocrine dysfunction;
(7) received ovarian stimulation treatment or OCP in recent 3 months;
(8) no previous history of ovarian and other gynecological operations;
(9) male factors (oligoweak teratozoospermia, obstructive azozoospermia, occult spermatozoospermia, etc.);
(10) and other contraindications of assisted reproductive technology.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Obtain the number of follicles;