Clinical Research Directory

Day-4 Embryo Defragmentation: Blastocyst Rate and clInical Outcomes

Background: Embryo fragmentation is one of the main morphological parameters assessed during in vitro culture in assisted reproductive technology (ART). The presence of anucleate cytoplasmic fragments is commonly observed in human embryos and may negatively affect developmental potential and clinical outcomes. Embryo defragmentation at early stages (Day 2-3) is an established technique in some centers, but evidence remains heterogeneous. Defragmentation at Day 4 (morula/compaction stage) represents a significantly less explored area, with promising but insufficient data to guide clinical practice. Study Objective: This study aims to evaluate whether mechanical or laser-assisted embryo defragmentation performed on Day 4 (D4) of in vitro culture improves blastocyst development rates and clinical outcomes in ART cycles, compared to standard culture without intervention. Study Design: This is a prospective, randomized controlled trial (RCT) with single-blind assessment. Patients undergoing IVF/ICSI with embryos showing ≥10% fragmentation at D4 morphological evaluation will be randomly assigned (1:1 ratio) to one of two groups: Group A (Intervention): Mechanical/laser defragmentation at D4, followed by standard blastocyst culture Group B (Control): Standard blastocyst culture without any additional manipulation Randomization will be performed at the patient level using pre-generated block randomization lists, stratified by patient age (\<35 vs. ≥35 years), number of fragmented embryos at D4, and use of preimplantation genetic testing (PGT-A). Participants: Women aged 18-43 years undergoing IVF/ICSI cycles, with at least one embryo showing ≥10% fragmentation at D4 and destined for blastocyst culture. Key exclusion criteria include: donor gamete cycles, PGT-M as primary indication, embryos with \>50% fragmentation, or severe morphological compromise at Day 3. Primary Outcome: Rate of usable blastocysts (Gardner score ≥3BB) per embryo included in the study, assessed at Day 5 and Day 6 of culture. Secondary Outcomes: Overall blastocyst development rate (D5/D6), Gardner score distribution, blastocyst cryopreservation rate, implantation rate, clinical pregnancy rate (heartbeat at 7 weeks), ongoing pregnancy rate (beyond 12 weeks), live birth rate per transfer, and morphokinetic analysis (if time-lapse incubator available). Sample Size: Approximately 240 patients total (120 per arm), based on an expected blastocyst rate of \~42% in the control group vs. \~57% in the intervention group (15% absolute difference), with 80% power and α=0.05. A 15% dropout correction is applied. Duration: 6 months of enrollment plus 6 months of clinical follow-up (total \~12 months).

Mechanisms of Maternal Immune Tolerance in Early Pregnancy

This study explores the mechanisms of maternal immune tolerance in early pregnancy by characterizing immune cell profiles and functional pathways during the first trimester. The goal is to identify immunological factors that support healthy gestation and prevent complications such as miscarriages.

The Effect of a Four-Week Hatha Yoga Intervention to Improve Quality of Life, Anxiety, and Depressive Symptoms in Individuals Undergoing Assisted Reproductive Technology (ART) Treatment

The goal of this clinical trial is to learn if a four-week yoga program works to improve quality of life in people undergoing IVF (In Vitro Fertilization). It will also learn if a four-week yoga program decreases anxiety and depression symptoms in people undergoing IVF. The main questions it aims to answer are: * Does a four-week yoga program effect quality of life, anxiety, and depression symptoms in people undergoing IVF? * Do the effects vary by individual characteristics of the people in the study? Researchers will compare the yoga intervention group to routine care as usual. Participants will: * Participate in a weekly virtual yoga class for four weeks (total of four yoga classes), or follow routine care as usual while undergoing IVF. * Take three online surveys every 4 weeks. * Be involved in the study for 8 weeks.

Luteal Phase Support With GnRH Agonist After GnRH Agonist Triggering in IVF/ICSI Cycles

The development of stimulation protocols for in vitro fertilisation (IVF) has led to a paradox. It has now been established that obtaining a large number of oocytes is a key to success, but that it is also a risk factor for embryo transfer failure after puncture (disruption of endometrial receptivity due to luteal insufficiency) and a risk factor for complications such as ovarian hyperstimulation syndrome (OHSS).

Effect of Super-GDF9 on CAPA-IVM of COCs From Small Antral Follicles

CAPA-IVM (In Vitro Maturation) technology is an assisted reproductive method offering significant benefits in terms of safety and treatment costs, particularly for high-risk patients. These include individuals with ovarian hyperstimulation syndrome (OHSS), venous thrombosis, ovarian torsion, or polycystic ovary syndrome (PCOS). However, while the live birth rate in the CAPA-IVM group (35.2%) is comparable to conventional IVF (43.2%), the number of good-quality embryos and cumulative clinical pregnancy rates remain lower. Improving the CAPA-IVM culture process, particularly through the addition of growth factors found in follicular fluid, has shown promise in enhancing oocyte quality. Growth differentiation factor 9 (GDF9) and Bone morphogenetic protein 15 (BMP15) play critical roles in follicular development, with their heterodimer structure demonstrating the most positive effects on cumulus-oocyte complexes (COCs). Recent studies have identified a potent variant, super GDF9, which is \>1000 times more effective than GDF9 and surpasses cumulin, a heterodimeric growth factor. Super GDF9 enhances cumulus cell expansion and oocyte developmental competence, closely mimicking in vivo maturation. This study investigates the impact of supplementing super GDF9 during CAPA-IVM culture, aiming to improve outcomes of cumulus-oocyte complexes (COCs) from small follicles and ultimately enhance treatment success.

Effect of Salidroside on Pregnancy Outcomes in High Childbearing Age Patients in Viro Fertilization

With the decreasing of birth rate and population in our country, population problem has become a long-term and strategic problem. In addition to the decrease in the number of women of childbearing age and the impact of unmarried women, the increase in the incidence of reproductive disorders and the delay of marriage and childbearing are also important factors leading to the continuous decline of the birth population in China. Among them, ovarian aging is a key factor causing female fertility difficulties. Therefore, establishing an effective prevention and treatment strategy for ovarian aging is of great significance for improving female reproductive health and serving the national population strategy. Recently, several supplements have been found to promote folliculogenesis and improve oocyte quality. However, to date, there is no approved therapeutic agent for the treatment of ovarian aging. Therefore, it is urgent to develop effective strategies for the prevention and treatment of ovarian aging. Salidroside is the main active component of Chinese medicine Rhodiola, and its content is highest in the root of rhodiola, which is also the main medicinal part. The main efficacy of salidroside in traditional Chinese medicine is to benefit qi, promote blood circulation, unblock pulse and relieve asthma. At the same time, in basic research, more and more experiments have shown that salidroside has a variety of pharmacological properties, including anti-hypoxia, anti-fatigue and anti-aging effects, anti-cancer, anti-inflammatory, anti-oxidation, antiviral and so on. These pharmacological effects suggest that salidroside may be an effective drug for the prevention and treatment of atherosclerosis, Parkinson's disease, Alzheimer's disease, pneumonia and other diseases. In terms of aging, it has been confirmed that salidroside supplementation can prolong the life span of pseudogill oryzias zhan and rescue premature aging of human skin fibroblasts, etc., which further confirms. The aim of this study is to investigate the efficacy of salidroside as an adjuvant drug in improving the pregnancy outcomes of fresh embryo transfer in high childbearing age patients with poor ovarian response by comparing the pregnancy outcomes of fresh embryo transfer between salidroside group and blank control group. This pragmatic clinical study is expected to improve pregnancy outcomes of fresh embryo transfer cycles in women of advanced childbearing age with poor ovarian response.

Effect of Antioxydant-enriched Media on Blastocyst Euploidy Rates.

One of the most sensible factors in IVF culture conditions is the susceptibility of gametes and embryos to an induced increase in reactive oxidative species (ROS) caused by the artificial environment. This study aims to evaluate the impact of using antioxidant-supplemented media during culture to evaluate embryo ploidy rates in a prospective randomized trial using sibling oocytes.

Video-Supported Medication Education for Women Undergoing In Vitro Fertilization (IVF): Quality of Life and Psychosocial Effects

Reproductive health problems, particularly infertility, affect 48 million couples globally, ranking as the fifth most serious global obstacle for women. Infertility can lead to significant psychosocial effects, including stress, anxiety, and depression, with women experiencing these impacts more severely than men. In vitro fertilization (IVF) offers a solution but comes with emotional, physical, and psychosocial challenges, particularly for women, who often experience fatigue, headaches, weight gain, and stress. Effective support mechanisms, such as information and education, are crucial in improving the IVF experience. Video-assisted educational programs have shown promise in enhancing knowledge and reducing stress during IVF treatment. However, there is a lack of studies evaluating their impact on the quality of life and psychosocial status of women undergoing IVF. This study aims to examine the effect of video-supported training on drug use, quality of life, and psychosocial status of women during IVF treatment, hypothesizing that it will improve quality of life, increase emotional capacity, and reduce anxiety.

Assessment of Reproductive Outcomes in Non-Male Factor Infertility Patients: Conventional in Vitro Fertilisation Versus Intracytoplasmic Sperm Injection

The aim of this clinical trial is to evaluate the efficiency of two fertilization techniques used in Assisted Reproduction: conventional In Vitro fertilization (cIVF) and Intracytoplasmic Sperm Injection (ICSI), in terms of in-vitro and clinical results, in non-male infertility patients, comparing them in sibling oocytes. The main questions it aims to answer are: Does ICSI result in better fertilization rate, blastocyst rate or usable blastocyst rate? Does ICSI result in better pregnancy, clinical pregnancy and live birth rates? Researchers will compare cIVF to ICSI in sibling oocytes to assess if a technique offers better results. Participants undergoing an IVF/ICSI cycle will have their oocytes randomly divided in two groups: the oocytes from one group will be fertilized using cIVF and the oocytes from the other group using ICSI.

Exploring the Effect of Footbaths on Increasing the Success Rates in Vitro Fertilization

To evaluate the effectiveness of warm-water footbaths in enhancing pregnancy rates during IVF and to explore the underlying mechanisms involved.

Effectiveness of CBT in Improving Psycho-Neuro-Endocrine Factors in Women Following In Vitro Fertilization Program

The goal of this clinical trial is to learn if Cognitive Behavioral Therapy (CBT) can improve psychological, neurological, and hormonal aspects in women undergoing In Vitro Fertilization (IVF). The main questions it aims to answer are: * Is CBT effective in improving psychological aspects (anxiety, depression, and coping mechanism) in women undergoing IVF? * Is CBT effective in improving neuroendocrine aspects (cortisol levels, neuroepinephrine levels, free trioodothyronine levels) in women underoing IVF? Researchers will compare CBT to no intervention to see if CBT is effective in improving psychoneuroendocrine aspects.