Sequential Therapy of TCM Herbs to Improve the Success Rate of IVF-ET in Diminished Ovarian Reserve Patients

What Was Tested

In this phase 3 trial, researchers set out to test Cetrorelix.

A randomized controlled clinical trial was used in this study. 200 infertile patients with DOR were randomly divided into two groups.

It had two arms (groups): kidney-tonifying and blood-regulating herbs treatment group (experimental) and Western medicine group (active comparator).

The control group will be treated with conventional Western medicine.

The registry classes the interventions as drug.

More on the Plan

The study will be conducted on patients with DOR attending their reproductive medicine centre for proposed IVF-ET between January 2021and December 2022.

The trial is designed as a randomised, 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.

Treatment with the Chinese herbal formula will start on the 5th day of menstruation after entering the super-ovulation cycle.

Who Took Part

200 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: Consent to participate in this clinical trial and sign an informed consent form. Age ≤40 years, regular menstrual cycle between 21and 35 days in length. Meet the Western diagnostic criteria for DOR. Meet the criteria for identifying kidney deficiency in Chinese medicine. Planning to undergo IVF-ET for pregnancy.

The full record lists 5 inclusion and 11 exclusion criteria; among the exclusions: history of two or more previous spontaneous abortions (excluding biochemical pregnancy abortions) or three or more previous ets without obtaining a clinical pregnancy; premature ovarian failure or ovarian gonadotropin resistance syndrome; untreated uterine anomalies or abnormalities, including double uterus or longitudinal uterus (complete or incomplete).

How the Study Was Run

Design: randomized, parallel-group and single-blind.

Random assignment meant chance, not the researchers, decided who got Cetrorelix and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 2021-04-15 with completion listed for 2022-12-30.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of eggs obtained (time frame: up to 15 weeks from enrollment). Change from Baseline concentration of Serum anti-Mullerian hormone(AMH) before the proposed IVF-ET. Change from Baseline concentration of Serum follicle-stimulating hormone (FSH) before the proposed IVF-ET.

It also tracked 9 secondary outcomes, for example Change from Baseline concentration of antral follicle count(AFC) before the proposed IVF-ET, Concentration of follicular E2 level on the day of human chorionic gonadotropin(hCG) injection, Change from Baseline concentration of Serum luteinising hormone(LH) before the proposed IVF-ET, Quality egg rate (%), Total amount of ovulation-promoting drugs and Fertilisation rate (%).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Cetrorelix in 200 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.