Clinical Research Directory

The Effect of Mindfulness-Based Lifestyle Support Program on Infertile Women

This randomized controlled trial aimed to determine whether a mindfulness-based lifestyle support program would improve quality of life, lifestyle, mindfulness, attention and meditation level and treatment outcomes in women undergoing IVF treatment.

225 IU Versus 300 IU Starting FSH Dose in PPOS for Good-Prognosis Women

This randomized controlled trial will compare two starting doses of follicle-stimulating hormone (FSH), 225 IU and 300 IU, during progestin-primed ovarian stimulation (PPOS) in women undergoing in vitro fertilization (IVF) who have a good reproductive prognosis. Participants will be randomly assigned to receive either 225 IU or 300 IU of FSH at the start of ovarian stimulation. The study will evaluate whether the starting FSH dose affects oocyte and embryo outcomes, with blastocyst formation as the primary outcome. Other outcomes will include oocyte morphology, fertilization, embryo development, and embryo quality. The findings may help determine an appropriate starting FSH dose for women with a good prognosis undergoing IVF using the PPOS protocol.

The Effects of Carnitine Supplementation on Oocytes in Women Undergoing IVF Process

The goal of this clinical trial is to learn whether supplementation with L-carnitine improves outcomes in women undergoing in vitro fertilization (IVF). It will also evaluate the effect of supplementation on oocyte quality, embryo quality, and pregnancy rates. The main questions it aims to answer are: * Does supplementation improve the number and quality of oocytes retrieved during IVF treatment? * Does supplementation improve the number and quality of embryos obtained after fertilization? * Does supplementation increase the rates of biochemical and clinical pregnancy? Researchers will compare women receiving supplementation with women not receiving supplementation to determine whether the supplements improve IVF outcomes.

Intra-ovarian CAPA-IVM vs Standard IVM

This prospective study compares two approaches to obtaining mature oocytes for fertility treatment within the same participant. Immature oocytes are first retrieved from the right ovary and matured in the laboratory using a two-step biphasic capacitation in vitro maturation method (CAPA-IVM). Beginning on Day 5 of the same menstrual cycle, the left ovary undergoes minimal controlled ovarian stimulation followed by routine oocyte retrieval and IVF/ICSI. The primary objective is to evaluate the maturation of CAPA-IVM oocytes to the metaphase II (MII) stage and compare reproductive laboratory outcomes between the CAPA-IVM and minimal-stimulation OS-IVF approaches. Secondary outcomes include fertilization, embryo development, blastocyst formation, embryo quality, pregnancy and live birth outcomes, and safety.

Endometrial Immune Profile in Recurrent Implantation Failure

The goal of this observational study is to learn whether differences in the immune cells of the womb lining (endometrium) help explain why some women do not become pregnant despite several IVF attempts using good-quality embryos, a condition known as recurrent implantation failure (RIF). The study compares women with RIF to women who have had a natural, healthy pregnancy. The main question it aims to answer is: Do immune cells in the endometrium, including uterine natural killer cells, macrophages, B cells, and T cells, differ in number or function between women with RIF and fertile controls? Researchers will compare endometrial tissue and blood samples from the RIF group to samples from the fertile control group to see whether specific immune cell patterns are linked to implantation failure, and whether these differences could point to future treatment targets. Participants will: * Attend a consent appointment to discuss the study * Have a transvaginal ultrasound scan, if one has not already been done in the past 6 months * Confirm the timing of their cycle using a home ovulation test, an ultrasound scan, and a blood test * Have an endometrial tissue sample and a blood sample taken at the point in their cycle when the womb lining would normally be ready to accept an embryo

Human Menopausal Gonadotropin Research in Infertility Assessing Cumulative Live Birth With Frozen Embryo Transfer.

The goal of this multicenter, randomized, placebo-controlled, double-blind clinical trial is toto evaluate the efficacy and safety of a human menopausal gonadotropin (hMG) in the development of multiple follicles, pregnancy, and cumulative live birth as part of an Assisted Reproductive Technology (ART) cycle in in women with a diagnosis of infertility.

Plastic Detox During IVF Treatment

Environmental pollutants are present in many aspects of everyday life. Exposures to common household products, such as food packaging and cookware, may affect reproductive health. Many of these environmental toxicants are known as "endocrine disrupting chemicals" because they can interfere with the body's hormone systems. Our study aims to create a guide that explains common sources of environmental toxicants and offer practical steps to reduce exposure. The investigators will evaluate how well participants understand this information and how consistently the intervention is maintained over time. To assess whether these changes reduce environmental pollutant exposure, the investigators will measure levels of two classes of toxicants within the urine and blood at the beginning, middle and end of the study in patients struggling with infertility that are planning in vitro fertilization (IVF) treatment. The investigators will also measure the same chemicals in follicular fluid (fluid which surrounds developing eggs in the ovary) and seminal fluid (fluid which surrounds the sperm in semen) and compare these levels to samples from similar patients who did not receive the education or make environmental changes. The goal of this project is to determine whether simple changes to reduce exposure to environmental pollutants can lower chemical levels of toxicants in the body and whether this may ultimately impact outcomes for patients undergoing in vitro fertilization.

Purpose to Evaluate the Effectiveness of the Superovulation Stimulation Protocol Using Human Chorionic Gonadotropin (hCG) by Demonstrating Its Equivalence to Standard Controlled Ovarian Stimulation Protocols in Terms of Oocytes Retrieved, Blastulation While Maintaining an Economic Advantage

This study evaluates a more affordable medication protocol for ovarian stimulation during in vitro fertilization (IVF). Standard IVF protocols use medications called gonadotropins to stimulate the ovaries to produce multiple eggs, but these medications can be very expensive and create a barrier to treatment. This clinical trial tests whether substituting a significant portion of these standard medications with human chorionic gonadotropin (hCG) is just as effective. Researchers will compare the number and quality of eggs and embryos produced by women using the experimental hCG protocol versus those using the standard gonadotropin protocol. The main goal is to determine if the hCG method can provide similar clinical outcomes and safety profiles while significantly reducing the overall financial cost of IVF treatment.

Study of Abnormally Fertilized Embryos

The goal of this observational study is to determine the diploidy rate of haploid and triploid embryos from in vitro fertilization (IVF) cycles. The main questions it aims to answer are: * Can a molecular genetic fertilization check of abnormally fertilized embryos be used to expand opportunities for couples undergoing assisted reproduction treatment? * Is the chromosomal loss or gain present in abnormally fertilized embryos predominantly maternal in origin? For this purpose, we will evaluate the morphokinetics and ploidy of about 300 embryos with different types of abnormal pronuclear patterns (1PN, 2.1PN, and 3PN) that reach the blastocyst stage. Whenever possible, embryos with a non-diploid chromosomal complement will also be assessed to determine the origin (maternal or paternal) of the chromosomal set that has been lost or gained. Study subjects will follow their previously scheduIed IVF/ICSI treatment and no additional visits/interventions will be required for participating.

RCT Study on the Effect of ETN on Live Birth Rate in DOR Patients Undergoing IVF-ET

The goal of this clinical trial is to examine the effect of ETN on live birth rate in patients with diminished ovarian reserve (DOR) undergoing in vitro fertilizitaion-embryo transfer (IVF-ET). Four hundred and six patients with DOR will be enrolled randomly divided into treatment group and control group, with 203 patients in each group. The treatment group will receive electro-thumbtack needle (ETN) therapy, while the control group received placebo ETN. Both groups initiated treatment 1 to 3 menstrual cycles before IVF-ET and continued until the intramuscular injection of HCG (night injection) during the IVF cycle. The study will observe and compare the pregnancy outcomes (including live birth rate, clinical pregnancy rate, biochemical pregnancy rate, threatened abortion, abortion, oocyte retrieval, and embryo quality), ovarian reserve function, anxiety, depression, sleep status, and quality of life between the two groups.

BMI Versus Body Fat Percentage - Which is the Better Predictor of Fertility Outcomes in IVF Cycles?

The goal of this prospective observational cohort study is to evaluate whether body composition measured using bioelectrical impedance analysis (BIA) (including measures of body fat% and visceral fat) serve as a better predictor than body mass index (BMI) of outcomes of in vitro fertilization (IVF) cycles. Participants undergoing IVF will have body composition assessed using a BIA scale prior to treatment, including measurement of body fat percentage. Associations between BMI, BIA-derived body composition measures, and IVF treatment outcomes will be evaluated. Outcomes of interest include ovarian stimulation requirements, number of mature oocytes (eggs) retrieved, number of oocytes fertilized, and number and quality of embryos available for cryopreservation (freezing). Furthermore, ongoing pregnancy and miscarriage rates will be evaluated. The main question is to determine which of either BIA metrics or BMI are a better predictor of ongoing pregnancy or miscarriage rates. Furthermore, we would like to assess if there is an association between BIA metrics or BMI and the response to ovarian stimulation (egg recruitment), number and maturity rate of oocytes retrieved, number of oocytes fertilized and the number and quality of embryos available for cryopreservation. Participants will be asked to step on a BIA scale at the start of their cycle before taking medications to stimulate/recruit oocytes. This scale provides additional information on body fat % and visceral fat % in addition to body weight. The study aims to determine whether measures of adiposity obtained using BIA may provide a more informative assessment of the relationship between body composition and IVF outcomes than BMI alone.

Estradiol 8 vs 12 mg for Endometrial Preparation in HRT-FET

The goal of this clinical trial is to learn whether 12 mg or 8 mg of oral estradiol valerate is better for preparing the endometrium in women undergoing hormone replacement frozen embryo transfer (HRT-FET) cycles. It also aims to assess how these two doses affect pregnancy outcomes and cycle success. The main questions it aims to answer are: Does oral estradiol 12 mg/day improve the clinical pregnancy rate compared with 8 mg/day? Do the two doses differ in endometrial thickness, cycle cancellation, miscarriage, and embryo transfer outcomes? Researchers will compare oral estradiol valerate 12 mg/day with oral estradiol valerate 8 mg/day to see whether the higher dose leads to better endometrial preparation and higher clinical pregnancy rates. Participants will: Be randomly assigned to receive either oral estradiol 8 mg/day or 12 mg/day Undergo endometrial preparation before frozen embryo transfer Have endometrial thickness assessed before starting progesterone Undergo embryo transfer and follow-up to assess clinical pregnancy and other outcomes

Drospirenone-Primed Ovarian Stimulation Versus GnRH Antagonist Protocol in Poor Ovarian Responders Undergoing Freeze-All IVF/ICSI

Participants will: * Take either drospirenone (a daily pill) or the standard daily injection during their ovarian stimulation cycle, alongside their regular fertility hormone injections * Undergo egg retrieval, with all resulting embryos frozen (no fresh embryo transfer in this study) * Have a frozen embryo transferred in a later cycle * Complete two short questionnaires about their treatment experience - once before starting the injections/pills, and once after the stimulation phase ends * Be followed to determine if the embryo transfer results in a pregnancy

Correlation Of Clinical Outcomes After Transfer Of Good-Quality Morphology Embryos In Patients With A Favorable Prognosis And Non-Invasive Preimplantation Genetic Testing For Aneuploidy (NiPGT-A) Results

Non-invasive preimplantation genetic testing for aneuploidy (NiPGT-A) is an emerging approach that analyzes embryonic cell-free DNA (cfDNA) released into the spent culture medium (SCM) to assess chromosomal status without performing trophectoderm biopsy. This technique has the potential to reduce procedural invasiveness and eliminate biopsy-related risks while providing additional information for embryo selection in assisted reproductive technology (ART). However, the clinical value of NiPGT-A remains uncertain because available evidence is limited and largely derived from observational studies, with few studies reporting live birth outcomes. This prospective observational study aims to evaluate the correlation between NiPGT-A results and clinical outcomes after single blastocyst transfer in patients with a favorable prognosis undergoing IVF/ICSI treatment. In this study, embryos with good morphological quality will undergo non-invasive sampling of spent culture medium for cfDNA analysis. NiPGT-A results will be categorized into four groups: no result, euploid, mosaic, and aneuploid. The study will compare pregnancy and birth outcomes across these groups to determine the clinical utility of NiPGT-A in embryo selection strategies.

Development of an AI Platform for the Analysis of Sperm and Prediction of Their Clinical Potential

Prospective, multicenter research study with a split-sample design on semen samples, without intervention, to develop an artificial intelligence platform for the analysis of sperm samples and prediction of their clinical potential, in 500 semen samples, in an in vitro study over 24 months.

A Large-scale, Prospective Cohort Study Was Conducted to Explore the Association Between Environmental Exposure and Behavioral Factors and Infertility (the Success Rate of Assisted Reproductive Technology)

The aim is to explore the reasons for the failure of assisted reproductive technology (ART) in infertile patients in Hunan Province and seek ways to improve the success rate of ART. The study will focus on how environmental exposure (such as environmental pollutants related to plastic products) and lifestyle and social factors affect the success rate of ART in infertile patients. In order to explore these issues in depth, the study plans to collect 5,000 samples (male: female ratio 1:1), screen the research subjects from infertile patients who visited Xiangya Third Hospital in Changsha, Hunan Province, and establish a large-scale, prospective infertility patient cohort. By collecting multi-faceted information of the research subjects, including sociodemographic characteristics, lifestyle, basic health status, etc., and conducting long-term follow-up observations, the ART live birth situation of infertile patients is analyzed. In terms of research methods, a multivariate analysis method will be used to explore the association between various factors and ART success rate, and a risk prediction model will be constructed. In addition, the study also hopes to clarify the specific reasons for the failure of infertile patients to receive ART, provide a scientific basis for clinical decision-making, and provide guidance for the formulation of environmental protection policies and the improvement of public reproductive health literacy. In general, this study, through a large-scale, prospective cohort study, deeply explores the various factors that affect the success rate of ART in infertile patients, and strives to build a risk prediction model in order to improve the success rate of ART and bring more hope to infertile families.

Quantifying Uterine Elastography in Menstruating Women

This study is aiming to characterize the elasticity of the female reproductive tract including the uterus, cervix and ovary using shear wave elastography at different times during the menstrual cycle and define the standard reference range of normal uterine and ovarian elasticity. By doing so, the potential of using shear wave elastography to diagnose and predict outcomes for patients seeking fertility treatment might be established.

The EPIC Study: Exploring Paternal Age and the Influence on Blastocyst Culture

This study aims to assess the effect of age of the male partner and the reproductive ability of sperm prepared via sperm selection devices (Zymot) compared to routine embryologist selected sperm after density gradient centrifugation (DGC) preparation for intracytoplasmic sperm injection (ICSI) in patients undergoing in vitro fertilization treatment (IVF) of their infertility.

Male Infertility and Assisted Reproductive Technologies Research Biobank

The objective of this research is to build a biobank of biological male specimens used for diagnostics and treatment of infertility or assisted reproductive technologies (ART).

Blastocyst AI Assisted Morphokinetics in ART

The goal of this observational study is to learn if embryo characteristics obtained via the recording of real-time embryo activity via 30-seconds video capture (e.g.: Embryo Morphokinetics) can correlate with known embryo outcome in patients receiving In-Vitro Fertilization Treatment (IVF). Current Embryo morphology is performed with direct observation of embryo characteristics under the microscope. The observer will follow embryo grading standards based on embryo symmetry, development stage and growth pattern based on day of culture, presence of defined embryo characteristics with definition of viability to transfer into the uterus, cryopreserve for future use or discard. Today, the final embryo outcome can be correlated with the subjective embryo grading performed by the embryologist to evaluate how precise is the viability assessment of embryo characteristics and potential. This observational study attempts to create enough data to evaluate if real-time embryo morphokinetics can correlate with known outcomes. Patients participating in this study will not obtain any benefit from the recording of their embryos. They'll continue with their treatment according to the medical provider decision. Embryos will be selected using standard of care practice including: Transfer into the uterus. Cryopreservation. Biopsy for pre-implantation genetic testing and cryopreservation. Discard. The data obtained from this study will be analyzed to generate hypothesis and potentially design a prospective study where this tool can be used to aid in the embryo grading and selection process in comparison with standard of care. The study includes patients undergoing Assisted Reproductive Technologies (ART) including IVF, Intracytoplasmic Sperm Injection (ICSI), Frozen-Thawed Embryo Transfer including or not Embryos previously analyzed genetically. This includes embryos already defined as viable (genetically normal) or embryos to be discarded (genetically abnormal). What is Embryo Morphokinetics? Embryos are in constant movement with cellular activity invisible to the naked eye. Capturing a real-time video can convert that cellular movement and activity into pixels. Those pixels can be followed, and certain patterns can be observed and created. With the use of Artificial Intelligence (AI) those patterns can be identified, labelled, and analyzed to potentially be correlated with embryo outcome. It has been demonstrated, in the animal field, that embryos with certain morphokinetics patterns do not implant inside the uterus therefore not achieving a pregnancy. Also, embryos with high activity may be associated with genetic abnormality. In this study the following comparisons will be performed. Embryo Morphokinetics at the Blastocyst stage including: Blastocyst morphokinetics before cryopreservation and after thawing. Blastocyst morphokinetics before and after trophectoderm biopsy. Blastocyst morphokinetics in euploid embryos before transfer. Blastocyst morphokinetics in aneuploid embryos before discard. * Primary hypothesis: Blastocyst morphokinetics correlate with Pregnancy outcome * Secondary hypothesis: Blastocyst morphokinetics correlates with embryo recovery after thawing and after biopsy. * Tertiary hypothesis: Blastocyst morphokinetics correlates with know genetic diagnosis (euploid or aneuploid)

Triggering Ovulation in Normo-responders Using a Modified Dual Trigger Protocol or HCG Trigger

The aim of this randomized controlled study is to compare the efficacy of a modified dual trigger protocol \[a single bolos of HCG combined with two successive doses of a GnRH agonist \] with HCG \[a single bolos administered 36 hours before oocyte retrieval \] in triggering ovulation in normo-responders undergoing ovarian stimulation using the antagonist protocol.

Biological Aging Hallmarks-Guided Integrative TCM and Conventional Medicine in Post-Treatment Unexplained Female Infertility

The goal of this clinical trial is to determine whether telomere profiling and other biological aging hallmarks can help identify underlying mechanisms of persistent infertility in women with post-treatment unexplained infertility. The study also evaluates whether a personalized integrative treatment guided by these biomarkers can improve reproductive outcomes. The study includes women aged 25 to 42 years who continue to experience infertility despite appropriate management of identifiable reproductive conditions and repeated attempts with assisted reproductive technologies (ART), such as intrauterine insemination (IUI) or in vitro fertilization (IVF). The main questions this study aims to answer are: * Can telomere and biological aging hallmarks profiling identify a biological aging phenotype associated with infertility? * Can an integrative treatment guided by these profiles improve clinical pregnancy outcomes? Participants will: * Undergo a baseline reproductive evaluation and blood-based assessment of telomeres and aging hallmarks. * Receive an integrative approach combining Traditional Chinese Medicine (TCM), targeted nutritional support, and standard fertility care. * Proceed with natural conception attempts or standard assisted reproductive technologies following the preconception phase. * Participants will be followed to assess pregnancy outcomes and changes in biological aging hallmarks.

Norethindrone Impact on Receptiva Outcomes

This retrospective study aims to evaluate pregnancy outcomes in patients with a positive BCL6 test (ReceptivaDx, who were treated with either norethindrone acetate or Depo Lupron prior to embryo transfer. The current standard of care involves treatment with Depo Lupron, a GnRH agonist associated with significant hypoestrogenic side effects that mimic menopausal symptoms. Additionally, Depo Lupron is costly, with a retail price exceeding $2,000 per dose. In contrast, norethindrone acetate is a well-tolerated oral progestin, available at a fraction of the cost (under $100 for a one-month course). While prior studies have demonstrated comparable efficacy between Depo Lupron and norethindrone for managing endometriosis-associated pain, their relative effectiveness in improving reproductive outcomes-particularly in BCL6-positive patients undergoing embryo transfer-remains underexplored. This study seeks to address that gap by comparing ongoing pregnancy, live birth, and miscarriage rates between the two treatment groups. Hypothesis: IVF Patients testing positive for BCL6 and treated with norethindrone will not do worse than the current recommended treatment of 60 days Depo leuprolide as defined by two endpoint metrics, pregnancy rate and live birth rate.

Standardization of Variable Conditions of Embryo Transfer Into the Uterine Cavity in the Procedure of Medically Assisted Procreation in Humans

The EFECT study is a clinical trial designed to determine whether improving the consistency of embryo transfer procedures can increase pregnancy success in patients undergoing frozen embryo transfer (cryoET). While laboratory techniques for fertilization, embryo culture, and selection have advanced significantly, the process of transferring embryos to the uterus remains variable and depends on small procedural differences, such as temperature changes, mechanical forces, timing, and individual operator techniques. These variations may affect embryo survival and implantation, ultimately influencing pregnancy outcomes. This study tests whether using specialized devices to standardize key aspects of embryo transfer-specifically temperature stability during transport and controlled, precise embryo aspiration and expulsion speed, optimal fluid volume, programmed injection time, elimination of pressure fluctuations and plunger backflow, prevention of embryo re-aspiration and detection of transfer catherer oclusion-can improve pregnancy rates. All embryos in the study are cultured using time-lapse monitoring and selected using artificial intelligence-supported grading, ensuring uniform quality for all participants. The study compares standard manual embryo transfer with transfer using one or both of the devices: Embryocase, which maintains a stable temperature during transport, and Embryopass, which standardizes the procedure and eliminates human factor. A total of 160 participants are randomly assigned to one of four groups: manual transfer without device support, manual transfer with Embryocase, transfer with Embryopass, or transfer with both devices. Participants and outcome assessors are blinded to group assignment, while the staff performing the transfer are aware due to the nature of the devices. All participants receive standard luteal phase support with progesterone following routine clinical practice. The study's main goal is to evaluate whether these procedural improvements lead to higher rates of biochemical pregnancy (positive pregnancy test) and clinical pregnancy (confirmed by ultrasound). Secondary outcomes include implantation rate, live birth rate, device safety, and ease of use as reported by staff. Pregnancy outcomes, including delivery, pregnancy loss, or ectopic pregnancy, are followed until the end of pregnancy. By investigating the impact of procedural standardization, this study aims to determine whether technological improvements during embryo transfer can increase the effectiveness of assisted reproductive treatments. If successful, the results could support the broader adoption of standardized, device-assisted embryo transfer protocols in fertility clinics, helping more patients achieve successful pregnancies.