The Application of Zishen Yutai Pill in Aged Women Undergoing IVF-ET

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University1,467 enrolled

Overview

To explore the application of Zishen Yutai Pill in controlled ovarian stimulation and effect on pregnancy outcome in aged women undergoing in vitro fertilization-embryo transfer.

This will be a multi-center double-blind randomized controlled trial, which aims to explore the application of Zishen Yutai Pill in controlled ovarian stimulation and effect on pregnancy outcome in aged women undergoing in vitro fertilization-embryo transfer.The target population will be infertile women aged between 35 and 42 years, BMI\<28kg/m2 and bilateral ovaries who undergo IVF-ET (long or antagonist protocol). Qualified 1,466 patients are randomized into either of two groups.They will be randomized to receive either Zishen Yutai Pill or the placebo. The pregnancy test results and pregnancy complications will be followed up by checking medical records and telephone calls.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,467

Conditions

Infertility, Female

Interventions

Zishen Yutai PillDRUG

Patients who undergo the long-term protocol will start taking Zishen Yutai Pill on the day of pituitary suppression, 5g three times a day (Stopping on the first 1-4 days of menstruation), and patients who undergo the antagonist protocol will start taking Zishen Yutai Pill on the 19th to 23rd day of the previous menstruation cycle, 5g three times a day (Stopping on the first 1-4 days of menstruation). The drug will be taken till 2 weeks after transplantation. If the test result is confirmed as biochemical pregnancy (HCG\>50 IU/L), patients continue to take pills till 3 weeks after the clinical pregnancy determined by the ultrasound. If it is determined that the pregnancy test is negative, stop the drug.

PlaceboDRUG

Patients who undergo the long-term protocol will start taking Placebo on the day of pituitary suppression, 5g three times a day (Stopping on the first 1-4 days of menstruation), and patients who undergo the antagonist protocol will start taking Placebo on the 19th to 23rd day of the previous menstruation cycle, 5g three times a day (Stopping on the first 1-4 days of menstruation). The drug will be taken till 2 weeks after transplantation. If the test result is confirmed as biochemical pregnancy (HCG\>50 IU/L), patients continue to take pills till 3 weeks after the clinical pregnancy determined by the ultrasound. If it is determined that the pregnancy test is negative, stop the drug.

Eligibility

Sex: FEMALEMin age: 35 YearsMax age: 42 Years

Medical Language ↔ Plain English

Inclusion Criteria: * infertile women aged ≥35 and ≤42 years; * intend to undergo IVF/ICSI-ET (GnRH-a long protocol or GnRH-ant protocol); * BMI\<28kg/m2; * bilateral ovaries exist; * patients who voluntarily signed the informed consent and agreed to be followed up as required by the study protocol. Exclusion Criteria: * repeated implantation failure (previous three times or more IVF/ICSI-ET failure); * adenomyosis, uterine line constricted by uterine fibroid; * untreated bilateral hydrosalpinx; * endometrial diseases that have not been cured ; * known diseases that are not suitable for undergoing assisted reproductive technology or at the present not suitable for pregnancy; * patients who have taken traditional Chinese medicine or Chinese patent medicine for infertility treatment in the last month(30 days). Exit Criteria: * subjects who have adverse events cannot be tolerated; * severe breach of the protocol; * for subjects who exit due to personal or unpredictable reasons, please describe specific details; * subjects considered inappropriate to continue to participate in the study for other medical reasons.

Locations (12)

Chongqing Health Center For Women and Children

Chongqing, Chongqing Municipality, China

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Live Birth Rate

Live birth rate=Number of live birth / Paticipants randomized

Time frame: 1 year after embryo transfer day, up to a maximum duration of 58 weeks