Clinical Research Directory

Gamified Healthy Lifestyle Training in Women Undergoing Assisted Reproductive Treatment

Objective: A prospective randomized controlled trial with a pretest-posttest design was planned to evaluate the effects of a gamified healthy lifestyle behaviors training intervention using the D6 model, to be administered to women undergoing assisted reproductive treatment (ART), on healthy lifestyle behaviors and infertility self-efficacy. Aim: Reproductive health and Assisted Reproductive Technologies (ART) have undergone rapid technological and clinical development in recent years, offering a variety of treatment options to couples struggling with infertility. Methods such as Intrauterine Insemination (IUI), In Vitro Fertilization (IVF), and Intracytoplasmic Sperm Injection (ICSI) are the most common practices aimed at increasing pregnancy rates. However, these treatments are complex processes affected by high stress levels, emotional burden, and lifestyle factors. Strengthening individuals' sense of self-efficacy strengthens their motivation to adapt to treatment and achieve health-related goals. In this intense and complex treatment process, it is essential to strengthen the self-efficacy perceptions of infertile couples, as this can enhance their motivation to achieve health-related goals by improving their adaptation to the treatment process. Although the literature reveals findings indicating that the development of healthy lifestyle behaviors positively influences the treatment outcomes of individuals undergoing infertility treatment, it is an undeniable fact that developing and sustaining such behaviors is often challenging-even for healthy individuals. For those experiencing infertility, which represents a complex life crisis both psychologically and physiologically, this process can become even more difficult. In this context, gamification is intended to be utilized as an innovative approach by integrating it into the process of promoting healthy lifestyle behaviors among infertile women. Method: This study will be a prospective randomized controlled trial with a pretest-posttest model. The study population will consist of women undergoing assisted reproductive treatment who presented to the In Vitro Fertilization Unit in the Infertility and Reproductive Endocrinology Department at Istanbul University, Istanbul Faculty of Medicine Service Building, between October 2025 and October 2026. The sample will consist of 105 infertile women who met the study criteria based on a power analysis and agreed to participate in the study. After obtaining informed consent from infertile women who meet the study criteria and agree to participate, the women will be randomly assigned to three groups based on age, type of ART (IUI, IVF, ICSI), and number of treatments to ensure equality between the groups. These groups will be divided into three groups: a group receiving gamified healthy lifestyle behaviors education and a booklet during the ART process, a group receiving only the booklet, and a group receiving standard ART clinic training. All study groups will complete an Introductory Information Form, the Healthy Lifestyle Behavior Follow-up Form for Infertile Women, the Healthy Lifestyle Behavior Scale II (HLBS II), and the Infertility Self-Efficacy Scale Short Form (SES). One group will receive the gamified healthy lifestyle behaviors education program and a booklet, while the second group will receive the healthy lifestyle behaviors education booklet. The third group will receive standard ART clinic training. Post-tests (Healthy Lifestyle Behaviors for Infertile Women Follow-up Form, Healthy Lifestyle Behaviors Scale II, Infertility Self-Efficacy Scale Short Form) and "Gamified Healthy Lifestyle Behaviors Training Program Evaluation Form" was given to the group receiving gamified healthy lifestyle behaviors training will be administered to all groups at the end of Month 1. Repeat tests (Healthy Lifestyle Behaviors for Infertile Women Follow-up Form, Healthy Lifestyle Behaviors Scale II, Infertility Self-Efficacy Scale Short Form, and Gamified Healthy Lifestyle Behaviors Education Program Evaluation Form) will be administered at Month 3. As part of the study, the effects of gamified healthy lifestyle behaviors and self-efficacy on the healthy lifestyle behaviors and self-efficacy of infertile women who received gamified healthy lifestyle behaviors education and an educational booklet during the ART process will be compared with those of infertile women who received only the educational booklet, compared to those who received standard ART clinic training. This will scientifically demonstrate the contribution of the gamification approach to the behavioral change processes of infertile women.

Environmental and Behavioral Factors in Infertility and ART Outcomes

This large-scale study aims to understand how everyday environment and lifestyle may affect the success of fertility treatments like IVF. The main idea is that exposure to certain environmental chemicals (e.g., from plastics or air pollution) and personal habits (e.g., diet, stress) could be linked to whether these treatments result in a successful pregnancy and live birth. The study will follow approximately 5,000 couples undergoing fertility treatment in Hunan, China. Participants will answer questionnaires about their health, lifestyle, and environment and provide small biological samples (like blood and urine) during their standard treatment process. Their treatment outcomes will be tracked anonymously.The goal is to identify factors that might lower the chances of treatment success. This knowledge could help future patients and doctors make informed decisions and could guide public health advice on reducing potential risks. The study has received ethical approval, and all participant information will be kept strictly confidential.

Long-term Evaluation of Fertility Preservation Options in Women in Cancer Remission or Haematological Pathology

Cancer treatments, despite their increasing effectiveness, carry a significant risk of gamete toxicity. Women of reproductive age are commonly offered fertility preservation (FP) before starting their treatment. However, few studies have analyzed the long-term reproductive outcomes of these interventions, nor how patients ultimately use or do not use the FP options once in remission. This project aims to better understand the effectiveness, utilization, and psychological impacts of these strategies. This work is part of an effort to understand and evaluate fertility preservation practices implemented for women of reproductive age undergoing cancer treatment at the Amiens-Picardie University Hospital (CHU). Its objective is to document patient pathways, clinical decisions, techniques employed, and reproductive outcomes observed after remission, in order to identify potential areas for improvement in the support and follow-up of these patients, thereby enhancing the overall quality and coordination of care. This work is conducted alongside the development of a fertility observatory at the Department of Medicine and Reproductive Biology, CHU Amiens-Picardie.

Levothyroxine Treatment and IVF Outcomes in Women With Subclinical Hypothyroidism: A Target Trial Emulation

Subclinical hypothyroidism (SCH) is defined by elevated thyroid-stimulating hormone (TSH) with normal free thyroxine (fT4) levels. It affects approximately 5-7% of women of reproductive age and may negatively influence outcomes of assisted reproductive technology (ART). During controlled ovarian stimulation, rising estradiol increases thyroxine-binding globulin and thyroid hormone requirements. These physiological changes, combined with increased metabolic demand in early pregnancy, may worsen SCH and contribute to adverse outcomes such as miscarriage, preterm birth, and hypertensive disorders of pregnancy. Although levothyroxine (LT4) is routinely used to treat overt hypothyroidism, evidence for its benefit in SCH, especially among infertile women undergoing In Vitro Fertilization (IVF) or Intra-Cytoplasmic Sperm Injection (ICSI) with frozen embryo transfer (FET), remains inconclusive. Some trials and meta-analyses have shown reductions in miscarriage and neonatal mortality, while others have found no improvement in ART or obstetric outcomes. This study aims to evaluate the effectiveness of levothyroxine therapy on IVF/FET outcomes and subsequent pregnancy results in women with subclinical hypothyroidism and infertility. This retrospective cohort study will emulate the target trial to evaluate whether LT4 treatment, titrated to achieve a pre-transfer TSH \< 2.5 mIU/L, improves implantation, live birth, and obstetric outcomes compared with expectant management.

Family Foundations for Individuals Pregnant Via ART

The purpose of this study is to help expectant mothers build a coparenting bond and improve communication with a support person (co-caregiver). Participation will include completing two online surveys (one at 12-30 weeks gestation \& one at 3 months postpartum), providing two at-home bloodspot collections and returning the collections via mail. Studies suggest that stress increases inflammation. Investigators aim to explore this by collecting a small amount of blood at the first and last session. Participants will also attend 9 virtual one-two hour Family Foundations (FF) intervention sessions (at no cost to participants) with a supportive co-caregiver. Total time commitment will be 18 hours, max, over a 6 month period.

St Mary's Assisted Reproductive Technology and Cardiometabolic Health: Modifiable Targets for Multimorbidity Prevention (START-HEALThY)

The main causes of death in women are conditions affecting the heart and blood vessels (cardiovascular disease, CVD). Women who have difficulties getting pregnant (infertility) may be at increased risk, but the reasons for this are not clear. Infertility itself may be linked with poorer heart and blood vessel health, or fertility treatments such as in vitro fertilisation (IVF) could increase the risk. The study aims to understand the practicalities of obtaining detailed profiling of women's pre- and post- pregnancy heart, blood vessel and metabolic health. Two groups of women in Manchester University NHS Foundation Trust, will be recruited over 2 years: 1) women planning a pregnancy, either spontaneously or with IVF treatment after infertility, 2) women who previously took part in a pregnancy health study after IVF or non-IVF conception. Participants will attend a single research appointment where they will undergo a cardiometabolic health assessment. They will have their BMI calculated, body composition measured, a measurement of how well their blood vessels work using a blood pressure cuff around the arm and/or finger and blood sampling performed. A blood pressure cuff as well as a blood sugar sensor may be fitted to be worn after the appointment. Participants will be asked to complete a questionnaire(s), with follow-up for up to 13 months. The cardiometabolic health of those who conceived with or without IVF treatment and with or without a history of infertility will be compared at both time points to investigate the possibility of links between infertility, IVF processes and CVD risk and to understand any potential barriers to recruitment of individuals at either time point to guide future studies. This information could then be used in a full-scale study, including in pregnancy, to improve care and promote lifelong health for women with infertility.

Validation of Donor Oocytes Semi-automated Vitrification

Oocyte vitrification is an effective method of freezing which has been authorized in France since 2011. The arrival of this technique has led to real improvements in the survival rate of oocytes after warming compared to that observed after slow freezing, a method previously applied. Oocytes reheated after vitrification show excellent results in terms of vitality and recovery of cellular functionality. Indeed, the fertilization rates observed after using warmed and fertilized oocytes in Assisted Reproduction Technology (ART) by intracytoplasmic sperm injection (ICSI) are similar to those obtained with fresh oocytes. However, the manual vitrification techniques used until now involve a learning curve and a potential variability of the completion time depending on the operator and the number of oocytes to be vitrified. Oocyte vitrification is a key step to optimize the chances of pregnancy in ART after using these oocytes. However, manual vitrification requires a learning curve, is technician-dependent and requires significant technical time. A semi-automatic vitrification device (GAVI®, Merck), which recently appeared on the market, has demonstrated its effectiveness in terms of speed of production and reproducibility of vitrification of embryos obtained in ART. To our knowledge, no study has analyzed the effectiveness of semi-automatic vitrification (GAVI®, Merck) on survival and oocyte quality after warming. It would therefore be interesting to evaluate the effectiveness of this automaton on oocyte vitrification in the context of oocyte donation and to determine the impact of semi-automatic vitrification on oocytes compared to manual vitrification. The main objective of this study is to demonstrate the non-inferiority of vitrification semi-automated device (Gavi) of oocytes with regard to the oocyte survival rate, compared to the manual technique used in ART. The investigator will compare the effectiveness of semi-automated vitrification device with the manual technique, in terms of ART results by comparing the fertilization rates, the number and quality of embryos obtained as well as the implantation rates in oocyte recipient patients. This study will then allow clinical application of the most efficient protocol for oocyte vitrification in the context of oocyte donation. A cost/effectiveness study will be carried out.

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.

A Comparing Study Between SJ04 and Ovidrel® in Healthy Subjects

This is a single-centre, randomised, open-label, single-dose, two-cycle, double-crossover study to compare the pharmacokinetics of SJ04 and Ovidrel® in healthy female subjects. Received a single subcutaneous injection administration of SJ04 Injection or Ovidrel®, both administered at a dose of 250 μg, once per cycle, and cross-administered after a washout period.