Infertility Pregnancy and Childbirth
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age: 20 and 40 years (inclusive) 2. Planning to undergo first or second IVF or ICSI treatment cycle (oocyte retrieval cycle) 3. Each participant may only be enrolled once (limited to one oocyte retrieval cycle) 4. 1-6 normally fertilized oocytes (2PN) observed on Day 1 post-oocyte retrieval
Exclusion criteria
Exclusion criteria: 1. Cycles involving preimplantation genetic testing (PGT) 2. Use of frozen-thawed oocytes for fertilization 3. Use of donor oocytes 4. History of recurrent pregnancy loss (=2 spontaneous miscarriages) 5. Presence of uterine infertility factors (e.g., uncorrectable intrauterine adhesions, severe uterine malformations affecting pregnancy, or uterine fibroids compressing the uterine cavity) 6. Freeze-all cycles
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcomes as of 02/01/2026: Cumulative live birth rate (CLBR), defined as the delivery of a live-born infant at =24 weeks of gestation within 12 months following oocyte retrieval. This outcome includes live births resulting from both the fresh embryo transfer and any subsequent frozen embryo transfers (FETs) performed within the 12-month follow-up window, all derived from the same ovarian stimulation cycle. Previous primary outcomes: Cumulative live birth rate, defined as delivery of a live-born infant =24 weeks’ gestation, measured using hospital delivery records and national birth registries, assessed over a 12-month follow-up period from randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcomes as of 15/01/2026: Secondary outcomes, extracted from electronic medical records and perinatal databases (from transfer through delivery and up to 7 days postpartum), include: 1. Cumulative rates of clinical pregnancy and miscarriage 2. Live birth rate following fresh embryo transfer 3. Number of embryo transfers required to achieve the first live birth 4. Time to conception resulting in a live birth 5. Multiple pregnancy rate 6. Obstetric and perinatal outcomes(birth weight, gestational age at birth, and offspring sex) Previous secondary outcomes as of 02/01/2026: Secondary outcomes, extracted from electronic medical records and perinatal databases (from transfer through delivery and up to 7 days postpartum), include: 1. Live birth rate per embryo transfer cycle 2. Clinical pregnancy rate (fetal heartbeat confirmed by transvaginal ultrasound at 7–8 weeks) 3. Miscarriage rate (pregnancy loss <20 weeks’ gestation) 4. Time to live birth (days from oocyte retrieval to delivery) 5. Neonatal outcomes: birth weight, gestational age at birth, and offspring sex Previous secondary outcomes: The following secondary outcomes are measured using electronic medical records and data collected from perinatal databases at delivery and up to 7 days postpartum: 1. Live birth rate per transfer cycle 2. Clinical pregnancy rate (fetal heartbeat confirmed by transvaginal ultrasound at 7-8 weeks) 3. Miscarriage rate (’ gestation) 4. Time to live birth 5. Neonatal outcomes (birth weight, gestational age, offspring sex) | — |
Countries
China