Clinical Research Directory

Towards Optimal Fertility, Fathering and Fatherhood studY

This case-control study involving fertile and subfertile couples aims to identify male factors related to pregnancy likelihood, create a fertility index measure combining male and female factors to predict pregnancy likelihood, and examine how male factors relate to the semen physical and biological characteristics.

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.

Efficacy and Safety of a New Sperm Capacitation Method

Prospective, multicenter research study with a split-sample design on semen samples, without intervention, to evaluate the efficacy and safety of HyperSperm, a new sperm capacitation method, in 300 semen samples with various characteristics and abnormalities, in an in vitro study over 12 months.

Impact of Serum Progesterone Levels on Embryo Transfer Day on Clinical Pregnancy

Hypotheses: We hypothesize that serum progesterone levels on the day of embryo transfer in HRT-FET cycles are positively associated with clinical pregnancy rates. Aims: To evaluate the relationship between serum progesterone levels on embryo transfer day and clinical pregnancy outcomes in frozen-thawed embryo transfer cycles using hormone replacement therapy (HRT). Primary outcome: To compare the incidence of clinical pregnancy outcome in those infertility patients undergoing frozen embryo transfer with caterized Progesterone level on the day of embryo transfer Secondary outcomes: Biochemical pregnancy rate. Implantation rate. Early pregnancy loss rate. Ectopic pregnancy rate.

Factors Associated With Clinical Pregnancy Outcomes in Intrauterine Insemination (IUI) Cycles

Hypotheses: We hypothesize that variations in hormonal profiles (LH, estradiol, progesterone) during ovarian stimulation, follicular response, endometrial characteristics, and sperm quality parameters are significantly associated with clinical pregnancy outcomes in intrauterine insemination (IUI) cycles. Aims * To investigate the association between hormonal profiles on the trigger day (LH, estradiol, progesterone), follicular response, endometrial thickness, and sperm parameters with clinical pregnancy outcomes in IUI cycles. * To develop and validate a predictive model for clinical pregnancy incorporating key determinants such as female age, hormonal response, endometrial characteristics, and sperm quality. * To compare natural and gonadotropin-stimulated IUI cycles in terms of hormonal profiles, pregnancy outcomes, and cost-effectiveness. Primary Outcome Clinical pregnancy rate (CPR), defined as the presence of a gestational sac with a fetal heartbeat on ultrasound at approximately 6 weeks of gestation following intrauterine insemination. Secondary Outcomes * Biochemical pregnancy rate. * Ongoing pregnancy rate * Live birth rate

Androgen Effects on the Reproductive Neuroendocrine Axis, 2025 Version

This research study investigates whether male-level exogenous androgens inhibit the reproductive neuroendocrine axis in otherwise healthy (non-PCOS) females.

Female Autologous Platelet-Rich Plasma (PRP) Co-incubation With Husband's Sperm

Hypotheses: We hypothesize that infertility patients undergoing IUI who receive female autologous platelet-rich plasma (PRP) co-incubation with husband's sperm would have higher clinical pregnancy rate. Aims: * To determine if the use of female autologous platelet-rich plasma (PRP) co-incubation with husband's sperm in the IUI will show higher clinical pregnancy rate (CPR). Clinical pregnancy rate as determined by a positive serum beta-hCG test result and at least one gestational sac at 6 weeks gestation * To assess the safety of female PRP co-incubation with husband's sperm in the IUI. Primary outcome: To compare the incidence of clinical pregnancy outcome in those infertility patients undergoing IUI with female PRP co-incubation with husband's sperm group and non-PRP group. Secondary outcomes: * To evaluate the safeness between the female PRP co-incubation with husband's sperm in the IUI group and non-PRP group, including potential infection rate or other complications such as ectopic pregnancy and molar pregnancy * To evaluate the sperm quality between the intervention group and control group Data analysis: Data analysis will be performed using Statistical Packages of Social Sciences for Windows Expected results: The investigators expect that a 50% pregnancy rate increase after the application of female PRP co-incubation with husband's sperm in the IUI

Impact of a Predetermined Day 5 ET vs. a Predetermined Day 6 ET on Clinical Pregnancy Rate After ICSI Treatment

The aim of this prospective multicenter study is to investigate the influence of a predetermined embryo transfer on day 6 compared to a predetermined embryo transfer on day 5. The study population consists of the control group (predetermined embryo transfer on day 5) and the study group (predetermined embryo transfer on day 6). The primary endpoint is the clinical pregnancy rate (detection of a gestational sac) per embryo transfer and the secondary endpoint is the abortion rate per clinical pregnancy. The data from the multicenter study are obtained at three test centers (Fertility Center Dortmund, Fertility Center Essen and Fertility Center Bad Münder).

A Novel Integrative Non-invasive Embryo Selection Approach for IVF Based on MK-RS Analysis

During assisted reproductive technology treatment, embryo selection is an important process that may affect the clinical pregnancy rate. Many assisted reproductive technology units over the world have tried different approaches to increase the clinical pregnancy rate. Conventionally, the morphology of the embryo is assessed by the embryologist with naked eyes only. Nowadays, artificial intelligence (AI) has been used to assist in morphological assessment of the embryo. Our pilot study showed that the AI-enhanced morphokinetic (MK) analysis increased the accuracy in embryo selection by \~9%, while the detection rate for abnormal chromosomes in embryo has also been increased by Raman spectroscopy (RS) analysis. The combined MK-RS analysis will be able to complete embryo assessment within 5-6 days after fertilization. This method needs shorter time and is at lower cost when compared to invasive preimplantation genetic testing for aneuploidies (PGT-A). In this study, we have combined the following non-invasive techniques to assist in embryo screening. 1. Using time-lapse imaging (i.e. images of embryo being taken every 10 minutes inside the incubator) with AI)-enhanced MK analysis to assess the entire morphological changes of the embryo. 2. As the embryo releases metabolites during its growth, the spent culture medium will be collected after culture of the embryo and then be used for RS analysis, which is a kind of metabolomics-based non-invasive PGT-A, for screening chromosomal abnormalities of the embryo. This study will include two phases. In Phase I, it is a retrospective part. We will collect data to train the convolutional neural network (CNN)-enhanced MK with RS method on embryo selection, leading to the integrated approach (MK-RS). In Phase II, it is a randomized controlled trial and participants will be randomised into 2 groups. For the experimental group, embryo selection will be based on the MK-RS method, whereas embryo selection for the control group will rely on the traditional embryo assessment results alone. Then we will assess the clinical pregnancy rate and evaluate the efficacy of our approach finally. Patients who receive in vitro fertilisation (IVF)/ intracytoplasmic sperm injection (ICSI) treatment from The Assisted Reproductive Technology (ART) Unit of The Chinese University of Hong Kong, Prince of Wales Hospital will be recruited.

ARTLifeLine: Assisted Reproduction Technology (ART) Family Health and Development Trajectory Cohort (ARTLL)

The goal of this observational study is to study the health status of infertile couples and their offspring using assisted reproductive technologies. The main questions it aims to answer are: 1. On the basis of the assisted reproduction birth cohort and related research established by the team in the early stage, further expand the construction of the "tracking cohort of familial health and development using assisted reproduction", combine emerging technologies such as cross-database linking and integration, multi-omics sequencing and classical cohort research design, and carry out long-term longitudinal follow-up across generations, covering the whole life cycle and health in multi-dimension. 2. Build a disease risk prediction model for pregnant women and children with assisted reproduction. 3. Delineate the growth curve and neurobehavioral development trajectory of assisted reproductive offspring at different stages. 4. Evaluate the adolescent fertility potential and risk factors of assisted reproductive offspring.

The Therapeutic Effects of Bu Shen Yi Jing Pill on Semen Quality in Sub Fertile Males: a Randomized Controlled Trial

This study aims to evaluate the safety and efficacy of Bu Shen Yi Jing (BSYJ) Pill , a type of traditional Chinese medicine, in improving male subfertility and semen parameters.