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Cumulative live birth rate after cleavage-stage versus blastocyst-stage embryo transfer in women with low prognosis

Cumulative live birth rate following cleavage-stage versus blastocyst-stage embryo transfer in women with low prognosis: a prospective quasi-experimental study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN44117747
Enrollment
120
Registered
2025-12-16
Start date
2025-11-01
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility Pregnancy and Childbirth

Interventions

Current interventions as of 15/01/2026: This is a prospective, non-randomized, quasi-experimental study employing a time-based allocation strategy. Eligible participants were assigned to one of two em

Sponsors

Northwest Women's and Children's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

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

MeasureTime 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

MeasureTime 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

Contacts

Public ContactDanmen Liu
liudanmeng1214@stu.xjtu.edu.cn+86 18192515962

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 17, 2026