Clinical Research Directory

PRP Improves Blastocyst Formation in ICSI Cycles

The goal of this clinical trial is to learn if platelet rich plasma (PRP) works to improve embryo development rates and embryo quality in IVF cycles, involving male adult patients with severe sperm disorders. The main questions it aims to answer are: * Does PRP improve sperm quality of male adult patients undergoing IVF? * Does PRP improve embryo development and embryo quality of the IVF patients? Researchers will compare embryos from IVF patients treated with PRP to those not treated with PRP to see if PRP improves embryo development and embryo quality. Participants will: * Provide semen sample for IVF * Provide blood sample for PRP preparation * Have PRP obtained from their blood added to their sperm sample

Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI Cycles

This is a prospective, multicenter, randomized controlled clinical trial designed to evaluate whether a fully undisturbed closed embryo culture system can improve the developmental potential of embryos cultured in vitro and provide high-quality evidence for its clinical application. Participants must meet all of the following criteria to be eligible for this study: 1）Patients meeting the indications for IVF or ICSI; 2)No more than two previous IVF/ICSI embryo transfer cycles; 3) Willingness to culture all fertilized embryos to the blastocyst stage (Day 5/6); 4) AMH ≥1.2 ng/mL and AFC ≥7; 5) Fewer than 20 oocytes retrieved and serum estradiol level on the day of hCG administration \<5000 pg/mL. Exclusion Criteria (Participants meeting any of the following criteria will be excluded): 1）History of low fertilization rate in previous cycles (fertilization rate \<25%); 2）Oocyte donation or sperm donation cycles; 3）Either partner has a known chromosomal abnormality on karyotype analysis, or the couple plans to undergo preimplantation genetic testing (PGT); 4）Conditions that may affect oocyte quality, including premature ovarian insufficiency, endometriosis, ovarian endometrioma, or a history of two or more pelvic surgeries; 5）Requirement for surgical sperm retrieval, including microsurgical sperm retrieval or testicular sperm extraction; 6）Significant untreated uterine factors that may impair embryo implantation, including: submucosal uterine fibroids; two or more intramural fibroids, with the largest diameter ≥3 cm and significant compression of the uterine cavity causing cavity distortion; untreated moderate to severe intrauterine adhesions; one or more endometrial polyps with a maximum diameter ≥1.0 cm, or two or more space-occupying endometrial polyps within the uterine cavity; untreated moderate to severe hydrosalpinx (diameter ≥3 cm); 7）History of fertilization or oocyte maturation disorders, including fertilization failure in a previous ICSI cycle or previous oocyte maturation disorder. After ovarian stimulation, all cumulus-oocyte complexes (COCs) from each patient will be randomly allocated in a 1:1 ratio to the control group or the experimental group.In the control group, oocytes will be fertilized using Vitrolife fertilization medium and cultured in a conventional sequential culture system consisting of a benchtop incubator and sequential culture media. In the experimental group, oocytes will be fertilized using Gems FEM fertilization medium and cultured in an undisturbed system consisting of a Geri incubator and Gems one-step culture medium. After culture of all embryos to the blastocyst stage, a single best-quality blastocyst (better than 4BC) will be selected for transfer according to the Gardner morphological grading system, provided that patient interests are not compromised. The primary outcome is clinical pregnancy rate, defined as the proportion of clinical pregnancy cycles among all embryo transfer cycles. Clinical pregnancy will be assessed 4-7 weeks after embryo transfer by ultrasound detection of an intrauterine gestational sac or pathological confirmation of miscarriage tissue. Secondary outcomes include fertilization rate, normal fertilization rate after ICSI, cleavage rate, Day 3 good-quality embryo rate, Day 3 usable embryo rate, good-quality blastocyst formation rate, Day 5/6 usable blastocyst rate, blastocyst formation rate, implantation rate, biochemical pregnancy rate, early miscarriage rate, ongoing pregnancy rate, live birth rate. Based on an average clinical pregnancy rate of 50%, and assuming a non-inferiority margin of 12% (Δ = -0.12), with α = 0.05, β = 0.20, 80% power, and 1:1 allocation, at least 430 cycles will be required. After allowing for a 10% dropout rate, a total of 478 cycles (239 per group) will be enrolled. Participant recruitment is planned from November 1, 2025, to December 30, 2027, across the following 12 study centers: Center for Reproductive Medicine, The Sixth Affiliated Hospital, Sun Yat-sen University (leading center); Center for Reproductive Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology; Reproductive Center, Northwest Women's and Children's Hospital; Shenzhen Zhongshan Obstetrics and Gynecology Hospital; Assisted Reproduction Center, Jiangxi Maternal and Child Health Hospital; Center for Reproductive Medicine, West China Second University Hospital, Sichuan University; Center for Reproductive Medicine, General Hospital of Ningxia Medical University; Reproductive Center, Affiliated Hospital of Jining Medical University; Center for Reproductive Medicine, Nanjing Maternal and Child Health Care Hospital; Reproductive Center, Chenzhou First People's Hospital; Center for Reproductive Medicine, Changde First People's Hospital; and Center for Reproductive Medicine, The First Affiliated Hospital of Hainan Medical University.

Noninvasive Implantation Potential vs Morphology-Based Selection in IVF Single Blastocyst Transfer

Background: Morphology-based embryo selection cannot detect aneuploidy, which is common in advanced maternal age and recurrent pregnancy loss. NICS-AI combines non-invasive chromosome screening (NICS) of cell-free DNA from spent blastocyst culture medium with AI integration of developmental day and morphology to improve embryo ranking. Methods: This multicenter, single-blind, parallel randomized controlled trial will include 520 participants. Participants undergoing conventional IVF will be eligible if they meet either (i) female age 35-43 years or (ii) recurrent miscarriage (≥2 losses \<28 gestational weeks, including biochemical pregnancy with serum hCG \>25 IU/L). They must consent to blastocyst culture/vitrification and frozen-thawed single blastocyst transfer (SBT), and have ≥2 Day-5/Day-6, 2PN-derived blastocysts with morphology grade ≥4BC/4CB at randomization. Key exclusions include any ICSI-based fertilization or PGT-related procedures, known genetic disease meeting PGT indications, donor oocytes, untreated uterine anomalies/hydrosalpinx, or contraindications to pregnancy/ART. Randomization/interventions: Participants will be randomized 1:1 to NICS-AI-guided selection or morphology-based selection. In the NICS-AI arm, culture-medium DNA is tested and an AI-derived composite implantation score ranks embryos; controls use morphology alone (tie-break by cryopreservation order). Outcomes/analysis: The primary endpoint is live birth after the first SBT (delivery with ≥1 live-born infant per transfer cycle, per randomized participant). Secondary endpoints include first clinical pregnancy, early miscarriage (\<12 weeks, excluding biochemical pregnancy), ongoing pregnancy to 12 weeks, and cumulative pregnancy/live birth outcomes within 1 year (≤3 SBTs from one retrieval). Safety includes fetal malformations and neonatal outcomes through 1 year postpartum.