Multi-Site Cortical Puncture for DOR

Key reproductive-related indicators for the second ovarian stimulation and oocyte retrieval cycle

Antral follicle count (AFC), anti-Müllerian hormone (AMH), number of follicles ≥14mm on HCG day, number of MII-stage follicles, number of fertilizations, number of 2pn embryos, number of embryos, and number of high-quality embryos;

Time frame: From the date of randomization to the third month after the second ovulation induction and oocyte retrieval surgery, the assessment period can last up to 7 months.

Rate of biochemical pregnancy

A blood pregnancy test is performed 14 days after embryo transfer. A positive result is defined as biochemical pregnancy. The rate of biochemical pregnancy is calculated using the following formula: (Number of cycles with positive blood hCG / Number of transfer cycles) × 100%.

Time frame: From the date of randomization to the occurrence of biochemical pregnancy after this embryo transfer, the assessment period can last up to 24 months.

Clinical pregnancy rate

Transvaginal ultrasound examination performed 4-5 weeks after embryo transfer is conducted. If intrauterine gestational sac, ectopic pregnancy, or combined intrauterine and extrauterine pregnancy is detected, it is classified as clinical pregnancy. The clinical pregnancy rate is calculated using the following formula: (Number of cycles with clinical pregnancy / Total number of embryo transfer cycles) × 100%.

Time frame: From the date of randomization to clinical pregnancy after this embryo transfer, the assessment period can last up to 24 months.

Implantation rate

Transvaginal ultrasound examination performed 4-5 weeks after embryo transfer. If intrauterine or ectopic gestational sacs are detected, implantation is confirmed. (Number of gestational sacs / Number of transferred embryos) × 100%

Time frame: From the date of randomization to implantation at the 5th week after embryo transfer, the assessment period can last up to 24 months.

Abortion rate

Early abortion rate (number of cycles with miscarriage occurring before 12 weeks / total clinical pregnancy cycles) × 100%; Mid-to-late abortion rate (number of cycles with miscarriage occurring between 12 weeks and 28 weeks / total clinical pregnancy cycles) × 100%.

Time frame: From the date of randomization to miscarriage after this embryo transfer, the assessment period can last up to 30 months.

Live birth rate

(Number of transplant cycles achieving at least one full-term live birth at 28 weeks / Total number of transplant cycles) × 100%

Time frame: From the date of randomization to the birth of a full-term live fetus following this embryo transfer, the assessment period lasts up to 36 months.

Cumulative pregnancy rate

The proportion of patients who ultimately achieve clinical pregnancy, calculated until all transplantable embryos obtained from two consecutive IVF/ICSI cycles are exhausted.

Time frame: From the date of randomization to clinical pregnancy after exhaustion of transplantable embryos, the assessment period lasts up to 100 months.

Cumulative live birth rate

The proportion of patients who ultimately achieved live births (gestation ≥28 weeks) using transplantable embryos obtained from two consecutive IVF/ICSI cycles until all embryos were exhausted.

Time frame: From the date of randomization to the birth of a full-term live fetus after exhaustion of transplantable embryos, the assessment period lasts up to 100 months.

Adverse neonatal outcomes

primarily including preterm birth, stillbirth, low birth weight infants, and birth defects;

Time frame: From the date of randomization to one year after the birth of the newborn, the assessment period can last up to 100 months.

Incidence of adverse events

Adverse events and serious adverse events, with a focus on evaluating the incidence of puncture-related adverse events (e.g., bleeding, injury, infection).

Time frame: From the date of randomization to the date of adverse event occurrence, the assessment period lasts up to 100 months.