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

Sun Yat-sen University

Status: Completed

Conditions: Infertility, Female

Treatments: Drug: Zishen Yutai Pill; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03703700

2018112704

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,467 patients

Sex: Female

Ages: 35 to 42 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,467 participants in 2 patient groups, including a placebo group

Zishen Yutai pill group

Experimental group

Description:

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.

Treatment:

Drug: Zishen Yutai Pill

Placebo group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo