Clinical Research Directory

Autologous Platelet-Rich Plasma Intra-ovarian Infusion in Poor Responders

Autologous PRP intra ovarian infusion may improve ovarian response, patients' hormonal profile as well as fresh embryo transfer (ET)-ICSI cycles' outcome in patients presenting with Poor Ovarian Response (POR).

Autologous Platelet Rich Plasma Intraovarian Infusion for Poor Responders

Autologous platelet rich plasma (PRP) intraovarian infusion may improve ovarian response to controlled ovarian stimulation as well as the hormonal profile of poor ovarian response infertile women subjected to intracytoplasmic sperm injection (ICSI) treatment.

Autologous PRP Intra Ovarian Infusion to Restore Ovarian Function in Menopausal Women

Autologous PRP intra ovarian infusion may restore ovarian function, may promote folliculogenesis and may improve hormonal profile of women in menopause.

Effects of GLP-1RAs on Fertility Outcomes in Obese Women With PCOS

The goal of this clinical trial is to examine whether GLP1-RA and healthy lifestyle education in women with PCOS and obesity prior to fertility treatment improves live birth rate and other reproductive, maternal and perinatal outcomes compared to metformin plus healthy lifestyle education.

Impact of a Web-Based Mind-Body Awareness Program on Women Undergoing Infertility Treatment

The goal of this two-group parallel randomized controlled study is to determine the effect of a web-based mind-body-based awareness program based on Meleis Transition Theory on fertility awareness and readiness levels in women receiving infertility treatment.

The REBALANCE Study - a Prospective, Multicenter, Randomized, Pivotal Study of the May Health System

A Prospective, Multicenter, Randomized, Pivotal Study of the May Health System in Transvaginal Ablation of Ovarian Tissue under Ultrasound Guidance in Women with Infertility due to Polycystic Ovary Syndrome

Sleep Length and Euploid Embryo Transfer Prospective Study

Sleep is a critical component of daily life that significantly influences health and well-being. Despite the integral role sleep plays in life, its effect on women's reproductive health, and its subsequent impact on fertility, is largely understudied. The purpose of the SLEEP Study is to investigate the link between sleep and fertility. Participants will use a wireless wearable device mounted on the finger to measure sleep in the weeks preceding and following an embryo transfer during treatment with in vitro fertilization. The investigators hope that these findings will inform future therapies that improve sleep and fertility outcomes.

Optimal Timing of Euploid Day 6 Blastocyst Transfer in Frozen HRT Cycles, Day 6 or Day 7 of Progesterone Administration.

The goal of this study is to compare the difference in clinical pregnancy, miscarriage and livebirth rate between day 6 euploid blastocyst transfer on the 6th and the 7th day of progesterone exposure in Hormonal Replacement Therapy (HRT) FET cycles. This prospective \& randomized study will only include euploid day 6 blastocysts. This will be the first prospective study of euploid day 6 blastocysts thereby excluding aneuploidy as a cause of miscarriage and implantation failure. The point of randomization will occur on the day of progesterone commencement.

Is Decreased Ovarian Reserve Related to an Increased Number of Previous Early Miscarriages?

This study aims to explore the potential correlation between decreased ovarian reserve and previous history of early miscarriage.

Multifaceted Benefits of Auricular Point Sticking for IVF Patients: Psychological Well-being, Sleep, and Treatment Outcomes

The goal of this clinical trial is to evaluate whether the complementary intervention of auricular point sticking therapy (APST) can improve pregnancy outcomes by ameliorating psychological distress and sleep quality in female patients aged 20-45 years undergoing in-vitro fertilization and embryo transfer (IVF-ET) who also present with anxiety and/or insomnia. The main questions it aims to answer are: Does the addition of APST to standard luteal phase support improve key IVF-ET pregnancy outcomes (embryo implantation rate, clinical pregnancy rate, ongoing pregnancy rate)? Does APST effectively reduce anxiety and depression scores (measured by GAD-7 and PHQ-9) and improve sleep quality (measured by PSQI and actigraphy) in this patient population? Are the observed clinical improvements associated with modulation of stress-related biomarkers (e.g., serum cortisol, 5-HT)? Researchers will compare the intervention group (standard care + APST) to the control group (standard care only) to see if the combined therapy leads to superior outcomes in psychological well-being, sleep parameters, and ultimately, reproductive success. Participants will be randomly assigned to either the control group or the intervention group. In the control group, receive standard luteal phase support medication (e.g., progesterone injections or oral dydrogesterone) for 4 weeks post-embryo transfer. In the intervention group, receive the same standard medication plus auricular point sticking therapy. This involves: 1.Having vaccaria seeds attached to specific ear acupoints (Heart, Liver, Endocrine, Shenmen, Subcortex, Sympathetic). 2.Performing self-acupressure on the seeds 3 times daily for 3 minutes each session. 3.Replacing the seeds at a new site every 3 days. 4.Complete psychological (GAD-7, PHQ-9) and sleep quality (PSQI) questionnaires at baseline and 12 weeks post-transfer. 5.Wear an actigraphy device on the wrist for 7 consecutive days to objectively monitor sleep patterns. 6.Provide blood samples for biomarker analysis (cortisol, 5-HT) on specific days post-transfer. 7.Undergo follow-up assessments to determine pregnancy status (β-hCG test, ultrasound).

Descriptive Analysis of Serum Immunological Markers During an Euploid Frozen Embryo Transfer in a Natural Cycle.

To describe the peripheral serum levels of the anti-inflammatory cytokines IL-4 (Interleukin-4), IL-10 (Interleukin-10), TGF-ß1 (Transforming Growth Factor beta1), the pro-inflammatory cytokines IL-17 (Interleukin-17), IFγ (Interferon Gamma) and the immune mediator PIBF (Progesterone-Induced Blocking Factor) along a single frozen euploid blastocyst transfer in a natural cycle (NC) or Hormone Replacement Therapy (HRT).

PROspective Study of Mothers' and Infants' Social and Epidemiologic Determinants of Health

The goal of the PROMISE study is to determine how pre-conception lifestyle factors (e.g., sleep, nutrition, physical activity) affect short- and long-term reproductive outcomes.

Evaluation of a Long Versus Short Clomid Protocol for Controlled Ovarian Stimulation

The goal of this clinical trial is to evaluate a long Clomid protocol as compared to a 5-day Clomid protocol for ovarian stimulation in patients with diminished ovarian reserve undergoing ovarian stimulation for in-vitro fertilization. The aim of the long Clomid protocol is to intensify stimulation of the ovaries and reduce both cost and injection burden for patients. Participants will be randomized to receive the long Clomid protocol vs. the typical protocol involving Clomid only for 5 days followed by growth hormone-releasing hormone (GnRH) antagonist. The primary outcome the investigators will evaluate will be the number of mature eggs retrieved.

Experimental Study on the Use of Intrauterine Infusion of Autologous Platelet-rich Plasma (PRGF-IUI) in Patients With Recurrent Implantation Failure and/or Refractory Thin Endometrium

Endometrial receptivity is a key determinant of success in assisted reproductive technology (ART). A significant proportion of patients experience repeated implantation failure despite euploid embryos and adequate laboratory conditions. Thin endometrium, often defined as ultrasound-measured thickness \<7 mm at embryo transfer, is frequently refractory to estrogen therapy and associated with low implantation and clinical pregnancy rates. Platelet-Rich Plasma (PRP), obtained from autologous blood by double centrifugation, is rich in growth factors capable of stimulating cell proliferation, angiogenesis, and tissue regeneration, suggesting potential benefits for endometrial function. Preliminary studies indicate improved endometrial thickness and reproductive outcomes following intrauterine PRP infusion, but standardized protocols and systematic data are lacking. The PMA\_PREPAIRE study is a prospective, single-center, controlled, non-randomized interventional clinical trial conducted at the Reproductive Medicine Center of Cardinal Massaia Hospital, Asti. The study aims to evaluate the efficacy and safety of intrauterine infusion of autologous platelet-rich plasma (PRP), in association with hormone replacement therapy (HRT), in improving endometrial receptivity and reproductive outcomes in women with thin or refractory endometrium. The study includes a prospective control group treated with standard HRT alone. Eligible women will be treated with standard clinical care, with PRP infusion offered to those with insufficient response to HRT. Inclusion criteria include age 18-45, BMI 18-30 kg/m², history of ≥1 failed embryo transfer, EMT \<5 mm after ≥10 days of HRT, and normal routine lab tests. Exclusion criteria include endometrial disease, recent gynecological infection, and systemic conditions such as thrombocytopenia or coagulopathies. Procedures include standard HRT from cycle days 1-2, serial ultrasound monitoring of endometrial thickness from days 6-8, intrauterine PRP infusion if EMT ≤7 mm (up to three infusions per cycle), embryo transfer once EMT ≥7 mm, and follow-up through pregnancy testing and confirmatory ultrasound. Collected data will be analyzed using descriptive statistics, paired and unpaired comparative analyses, and multivariate logistic regression models to evaluate predictors of treatment response and reproductive outcomes (significance level p \< 0.05). A sample size of 34 patients per group was estimated to detect a 1.5 mm difference in endometrial thickness (EMT) with 90% statistical power. Considering an anticipated dropout rate of 15%, a total of 40 patients per group will be enrolled. The study includes: an intervention group consisting of 40 patients treated with HRT plus intrauterine PRP infusion; a prospective control group consisting of 40 patients with refractory thin endometrium treated with standard HRT alone, without PRP.

Progesterone-modified Natural Cycle for FET

Hormone replacement therapy (HRT) cycles, despite the ease of synchronizing embryo thawing and embryo transfer timing, increase the risk of pregnancies and obstetric complications compared to natural cycles (NC). By ensuring the presence of the corpus luteum while reducing the number of monitoring sessions, the progesterone modified natural cycle (P4mNC) offers more convenience for the patient than the normal NC. This study is designed to compare the effects of P4mNC and HRT cycles on FET outcomes.

Strategies for Pregnancy Achievement

The purpose of pilot study application is to build on the investigators' previous work that established the prospective association between stress and infertility. Specifically, the investigators hope to collect the preliminary data necessary to make them competitive to submit a R01 application to NIH for funding of a full-scale randomized controlled trial of an internet-based stress management program to examine its efficacy in decreasing stress and increasing pregnancy rates among women who have tried to get pregnant for 6-12 months without success. The program called Stress Free Now (SFN) was developed at the Cleveland Clinic and has been shown to be effective in lowering stress in a variety of populations. The program introduces concepts of mindfulness and cognitive-behavioral therapy to assist individuals in managing their stress levels. The intervention includes Internet-based interaction, daily emails and recommended relaxation practice of at least four days per week. Using targeted Facebook Ads and other recruitment modalities, the investigators will randomize 40 women ages 18-34 who have been trying to conceive for 6-12 months without success. The PI has been enrolling women in a similar study using this mechanism and has found it to be an efficient and cost-effective method of identifying potentially eligible individuals. Women will be randomized to SFN or a wait list control condition and will be followed for up to three months post-randomization with weekly journals as they try to conceive. The primary outcome of this randomized controlled trial is stress level, as measured by salivary alpha-amylase, while the secondary outcome will be pregnancy rate at the end of the three-month follow-up period.

Effect of Tadalafil on Endometrial Thickness and Frozen Embryo Transfer Outcomes

investigate the effect of different vasodilators as Tadalafil in women with unexplained infertility using IVF

Impact of a Mindfulness Intervention on Infertile Women Undergoing Assisted Reproductive Technique Treatments

Infertility and its treatments can have a significant impact on women's psychological health. Anxiety has a negative impact on quality of life during treatment and can lead to withdrawal of care. the investigators would like to test the effectiveness of an application available via the Internet that offers daily exercises such as mindfulness meditation. Women in the "treatment" group will be instructed to practice meditation exercises using the 15-minute daily application during in vitro fertilization treatment until pregnancy testing. Women in the control group will have the standard care of the centre. The investigators will measure the effectiveness of the intervention on anxiety, depression, quality of life and mindfulness aspects. The investigators will also assess the impact on the chances of pregnancy and stress.

Identification of Biomarkers in Cervical Mucus

Cervical mucus is a biological fluid secreted by the endocervical glandular epithelium whose quantitative and qualitative characteristics vary in response to the hormonal stimulus produced by the ovary during the woman's menstrual cycle. As a fertility factor, it performs numerous biological functions: transport, nourishment, defense and capacitation of spermatozoa, defense against pathogens of the female genital tract. The aim of this research will be to deepen the knowledge of the biochemical characteristics of cervical mucus, in particular to perform characterization by infrared spectroscopy, for the identification of diagnostic, prognostic and predictive biomarkers for disorders affecting the female reproductive system. A healthy control population and a cohort of patients affected by unexplained infertility will be enrolled for the longitudinal study of the menstrual cycle with ultrasound and hormonal monitoring and serial sampling of cervical mucus.

Immune Cell Populations in the Endometrium

Specialized immunological studies in the diagnostics of idiopathic infertility and recurrent miscarriages have limited applicability, as the role of the immune system in these conditions is not thoroughly understood. In ovulatory cycles, changes occur in the populations of uterine lymphocytes, which may influence the receptivity of the endometrium and the implantation of the embryo. Particularly notable are the changes in natural killer (NK) cells, which reach their peak during the luteal phase and regulate the invasion of the trophoblast. The dominant NK cells exhibit a CD56bright phenotype and differ in cytokine profiles from peripheral blood cells. Cyclical changes also affect macrophages and T lymphocytes; however, it is unclear whether their proportions differ in women with reduced fertility. There is a need to investigate how the composition of lymphocytes in blood influences the populations in the endometrium. The aim of this study is to analyze the correlation between peripheral and endometrial lymphocytes in women with idiopathic infertility and recurrent miscarriages, compared to fertile women.

Efficacy and Safety of Gushen Antai Pill on Ongoing Pregnancy Rate in Women With Normal Ovarian Reserve Undergoing IVF-ET

The purpose of this study is to investigate whether oral Gushen Antai pills supplementation for luteal phase support will improve ongoing pregnancy rate in women with normal ovarian reserve in fresh embryo transfer cycles.

Ovarian Tissue Allo-transplantation

Premature ovarian failure, also known as primary ovarian insufficiency (POI), or premature menopause, affects 1-2% of women under 40. The diagnosis is typically made based on high levels of follicle stimulating hormone (FSH) and absent or irregular menstrual periods. It leads to infertility and menopause-like effects (hot flashes and thin bones) due to low estrogen levels. POI can result from various factors such as genetic conditions, autoimmune diseases, or previous medical treatments like chemotherapy. Treatment of POI usually involves hormone replacement therapy and, if pregnancy is desired, assisted reproductive technologies such as in vitro fertilization (IVF) using an egg donor. However, IVF may not be an option for everyone due to personal, religious, ethical or financial reasons. Recent advances in medicine have identified ovarian tissue transplantation (OTT) as a potential solution. OTT involves transplanting either fresh or frozen ovarian tissue into the pelvic area, where it can begin functioning again. Studies in animals and humans have shown success in restoring hormonal function and even achieving pregnancies in some cases. Initial human trials of ovarian tissue transplants from another individual began with identical twins and have since expanded to include non-identical siblings with compatible tissue matches using immunosuppression. Success rates of OTT have been promising, with multiple live births reported between identical twins. Long-term studies indicate that transplanted tissue can remain functional for up to eight years. Ovarian tissue transplantation offers a promising avenue for women with POI to help restore fertility and hormonal function. Continued research and refinement of tissue techniques are essential to improve outcomes and expand access to this innovative treatment option. This study will enroll 10 participants who will undergo ovarian tissue transplantation donated by a non-identical sister using an immunosuppression protocol at University Hospitals.

Study on the Pharmacokinetics and Safety of QL1012D and Gonal-F® in Healthy Female Volunteers

The goal of this Interventional study is to Compare the Pharmacokinetics and Safety of Recombinant Human Follicle Stimulating Hormone Injection (QL1012D) and Gonal-F® in Healthy Female Volunteers. It aims to evaluate the bioequivalence of recombinant human follicle stimulating hormone injection (QL1012D) and Gonal-F®, both given subcutaneously.

Study of Endometrial Immune and Microbiological Modifications in Cases of Recurrent Implantation Failure and/or Recurrent Pregnancy Loss

The IMERR study aims to improve understanding of certain causes of infertility related to recurrent implantation failure (RIF) and/or recurrent pregnancy loss (RPL), conditions that affect many women undergoing assisted reproductive technology (ART). Despite medical advances, some patients repeatedly fail to achieve pregnancy, or experience repeated miscarriages. These situations may be linked to subtle immune or microbial disturbances in the uterus. This study seeks to identify immune and microbiological profiles in the endometrium during the implantation window-a crucial period when the embryo attaches to the uterine wall. We will compare women who have experienced RIF and/or RPL with women who have had no such history. Blood and uterine samples will be analyzed to investigate whether certain immune or microbial features are associated with these reproductive failures. The ultimate goal is to uncover predictive factors that may explain why some women experience implantation failure or pregnancy loss, and to lay the foundation for future personalized treatments to improve reproductive outcomes.