Traditional Chinese Medicine Herbs in the Freeze-all IVF Cycle

What Was Tested

This registered phase 3 trial tested Cetrorelix.

A randomized controlled clinical trial will be used in this study. 90 infertile patients are randomly divided into two groups.

It had two arms (groups): Traditional Chinese Medicine herbs treatment group (experimental) and Western medicine group (active comparator).

The treatment group will receive treatment with the Chinese herbal formula on the 5th day of the menstrual cycle and lasts to 14 days after IVF-ET.

The control group will be treated with conventional Western medicine.

The registry classes the interventions as drug.

More on the Plan

The trial is designed as a randomized, controlled clinical trial with two groups established by 1:1 equal allocation, a treatment group with interventions using herbs to tonify the kidneys and regulate blood and a control group treated using conventional Western medicine.

Enrolled subjects will be given a subject number during the screening process and, upon formal enrolment, will be randomly assigned to either the test or control group with a corresponding random number.

Interventions Treatment method Phase 1: The control group will be treated with conventional Western medicine, whereas the treatment group will receive treatment with the Chinese herbal formula.

Treatment with the Chinese herbal formula will start on the 5th day of menstruation cycle.

Who Took Part

The registry lists 90 planned participants were the target.

It was open to women only aged from 20 years up to 40 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Meet the diagnostic criteria for infertility. Meet the criteria for identifying kidney deficiency in TCM. Patients who Planning to undergo IVF-ET for pregnancy in their center, Age ≤40 years and ≥25 years. Previous embryo transfer failure ≥ 2 times. Menstrual cycle is basically normal, and normal ovulation has been monitored in the past.

The full record lists 7 inclusion and 8 exclusion criteria; among the exclusions: patients with endometritis, acute pelvic inflammatory disease, mycotic vaginitis, bacterial vaginitis, adnexitis or other systemic infections; it has been confirmed that there are obvious and serious other organic lesions in the reproductive organs; patients with allergic constitution.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

Because people in this Cetrorelix study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Cetrorelix group and the comparison group ran side by side rather than switching.

In this single-blind Cetrorelix study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2021-06-15 with completion listed for 2022-12-30.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Clinical pregnancy rate (%) (time frame: up to 6 weeks from enrollment).

It also tracked 1 secondary outcome, for example Concentration of β-human Choriogonadotropin(β-HCG).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Cetrorelix in 90 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cetrorelix compound page, all human trials.