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

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.

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.