In Vitro Fertilization

This research aims to compare the pharmacokinetics of SJ04, a biosimilar of Ovidrel4, in healthy Chinese female subjects aged 20 to 40 years. The study evaluates how similar the body processes these two recombinant human chorionic gonadotropin injections when given by subcutaneous injection. It is a randomized, open-label, single-dose, two-cycle, double-crossover trial involving healthy women to assess drug similarity and safety. Participants are randomly assigned to two groups: one receives SJ04 first followed by Ovidrel4 after a two-week washout period, and the other receives Ovidrel4 first followed by SJ04 after the same interval. Each injection is a single subcutaneous dose of 250 1g given once per cycle. The crossover design allows each subject to receive both treatments with a washout period in between. During the study, researchers monitor pharmacokinetic measures such as the area under the plasma concentration curve and peak plasma concentration on day 8 after dosing. They also track adverse events and immune responses. The trial involves screening, drug administration on specified days, and follow-up assessments to evaluate safety and drug behavior. Participation lasts through both cycles including the washout and observation periods.

Researchers are exploring a new non-invasive method to select embryos during assisted reproductive technology treatments such as IVF and ICSI. This study evaluates an integrated approach combining artificial intelligence-enhanced morphokinetic (MK) analysis using time-lapse imaging and Raman spectroscopy (RS) of the spent culture medium to improve embryo assessment. The goal is to increase the clinical pregnancy rate by accurately identifying embryos with chromosomal abnormalities without the need for invasive genetic testing. The study has two phases. Phase I is a retrospective study collecting data to train the AI model combining MK and RS methods. Phase II is a prospective randomized controlled trial where participants are assigned to one of two groups: embryos selected by the MK-RS integrated method or embryos selected by traditional morphological assessment by embryologists. Embryo images are captured every 10 minutes, and spent culture medium is analyzed by RS to detect metabolic markers. The MK-RS method aims to complete embryo assessment within 5-6 days after fertilization. Participants will undergo IVF/ICSI treatment with embryo culture using a time-lapse incubator. Researchers will collect images and culture medium samples to analyze embryo development and metabolic profiles. The main outcome measured is the clinical pregnancy rate at 6-8 weeks of gestation. Secondary outcomes include miscarriage rate, multiple pregnancy rate, ploidy status, and live birth rate. The study involves monitoring embryo development, collecting biological samples, and evaluating pregnancy outcomes through follow-up.

Researchers are evaluating the Aurora test, a non-invasive method aimed at improving embryo selection during In Vitro Fertilization (IVF) and Intracytoplasmic Sperm Injection (ICSI) cycles. The study focuses on women undergoing ICSI treatment and compares embryo selection based on traditional morphology with selection that also includes the Aurora test score. The goal is to see if this new test can increase clinical pregnancy rates and live birth rates. The Aurora test analyzes mRNA expression in cumulus cells surrounding the oocyte to predict the embryo's developmental potential, offering an objective alternative to current subjective assessments. The study involves patients undergoing either fresh or frozen single embryo transfers on day 5 after fertilization. The Aurora test is conducted by analyzing cumulus cells collected during oocyte retrieval. RNA is extracted and evaluated to assign an Aurora test score to each embryo, indicating its pregnancy potential. Embryos are first selected based on morphology, then ranked by this score to determine transfer order. If no live birth occurs and the trial is ongoing, frozen embryo transfer cycles will also use the Aurora test for selection. The study includes a prospective group and two matched historical control groups for comparison. Participants will have their cumulus cells collected and analyzed, with embryo development tracked by embryologists based on morphology and Aurora test scores. Outcomes measured include blastocyst selection at day 5, clinical pregnancy rates confirmed by ultrasound, and live birth rates. Patient eligibility, embryo development, and transfer outcomes will be monitored throughout the study, with data compared against historical controls. The total participation duration depends on treatment cycles and pregnancy outcomes, with follow-up extending through frozen embryo transfers if applicable.

This trial investigates different surgical methods for treating endometriomas, which are ovarian cysts larger than 2 cm, in adult women aged 18 to 43 who have symptoms like pelvic pain or fertility issues. The study aims to compare pregnancy rates within 24 months after surgery, along with birth rates, types of pregnancies, recurrence of cysts, complications, and changes in pain levels. Researchers seek to find which surgical approach yields better pregnancy outcomes and fewer problems. Participants are randomly assigned to one of three surgical treatments: cystectomy, where the cyst wall is gently removed from the ovary; plasma vaporization, which destroys the cyst wall using plasma energy; or ethanol sclerotherapy, which uses alcohol to destroy the cyst lining. After surgery, women will have follow-up visits at 3 months and 24 months to monitor their recovery and pregnancy progress. During the study, participants will be evaluated through medical imaging, symptom questionnaires, and monitoring of pregnancy outcomes including natural and assisted pregnancies. Researchers will track recurrence of cysts over 24 months and assess pain using a standardized scale. Safety and complications will be recorded during the first 3 months post-surgery. The total participation spans from surgery through two years of follow-up evaluations.

This research aims to improve pregnancy success rates in women undergoing frozen embryo transfers (FET) after in vitro fertilization (IVF). It evaluates whether placing a "blank" culture medium into the uterus a few days before the embryo transfer can enhance immune tolerance and support embryo implantation. The study compares this approach to a sham transfer procedure without the culture medium, focusing on women who have experienced previous embryo transfer failures. Participants are randomly assigned to one of two groups: the experimental group receives a small amount of warmed embryo culture medium injected into the uterine cavity two to three days before the frozen embryo transfer, while the control group undergoes a sham transfer with an empty catheter during the same timeframe. The study is single-blind and involves multiple centers. During the trial, researchers will monitor pregnancy outcomes, including early pregnancy occurrence, biochemical and clinical pregnancy rates at various time points, early miscarriage rates, and live birth rates. They will also assess cost-effectiveness between the two care strategies. Participant involvement includes consent, membership in a health insurance plan, and follow-up evaluations up to and beyond the pregnancy period, with the primary outcome measured at 12 weeks of amenorrhea.

Infertility is a significant medical condition affecting individuals and couples emotionally and physically, with in vitro fertilization (IVF) treatment requiring active patient involvement for success. This research aims to evaluate an artificial intelligence and machine learning (AI-ML) model called the Univfy PreIVF Report, designed to improve patient engagement and provide personalized predictions for IVF treatment outcomes. The study will prospectively assess how this AI-ML tool supports individualized patient needs in medically assisted reproduction. Participants are divided into two groups: a retrospective cohort analyzed after their initial visits between December 2024 and June 2025, and a prospective cohort who will receive the AI-ML based Univfy PreIVF Report alongside medical explanation from their physician during their new patient visit. This report offers accurate personalized probabilities of achieving a live birth, aiming to enhance adherence to treatment protocols and support informed decisions. Participants will be followed for up to nine months after enrollment to measure conversion rates to medically assisted reproduction treatments, with additional evaluations at three and six months. The study will track adherence to treatment recommendations and the effectiveness of AI-based counseling in fostering engagement. Outcomes will be assessed through conversion rates and patient adherence, providing evidence for integrating AI-ML technologies in reproductive medicine.

Researchers are investigating whether using artificial intelligence (AI) to guide monitoring and timing of ovulation trigger in women undergoing ovarian stimulation for in vitro fertilization (IVF) can achieve clinical outcomes similar to traditional physician-led decisions. This trial aims to compare AI-assisted decision-making with routine clinical management to optimize the number of eggs retrieved, improve workflow efficiency, and reduce clinical workload, especially weekend procedures. Participants will be randomly assigned to one of two groups: one where trigger decisions are made by the physician assisted by the AI software called STIMAI®, and the other where trigger timing is determined by the physician alone based on clinical judgement. The AI software analyzes patient data to predict the optimal trigger day, offering options for triggering today or tomorrow, while the physician makes the final decision. The study focuses on individualized treatment to improve outcomes and scheduling. During the study, participants will undergo controlled ovarian stimulation with regular monitoring including ultrasounds. Researchers will measure the number of mature eggs retrieved about 34-36 hours after ovulation trigger, as well as other outcomes like follicle counts, length of stimulation, and number of clinic visits. The trial also tracks spontaneous ovulation and the distribution of retrieval procedures throughout the week. Participation will last through the stimulation cycle until egg retrieval, with assessments of both clinical results and process efficiency.

Researchers are evaluating the effectiveness of the Opt-IVF decision support tool for personalized drug dosage in women undergoing IVF treatment in the United States. This randomized clinical trial aims to compare outcomes of patients receiving dosages predicted by Opt-IVF against those receiving standard physician-prescribed dosages. The study focuses on whether the Opt-IVF tool can provide better or similar results to current treatments by assessing various fertility outcomes. The trial involves two groups: one receiving dosages determined by their doctor as standard practice, and the other receiving dosages recommended by the Opt-IVF tool. The study will monitor treatment cycles and dosage profiles, comparing measures such as the number of mature follicles, total hormone dosages used, and embryo quality. This clinical trial is conducted for research purposes and the decision support tool has not been submitted for regulatory approval. Participants will be monitored closely throughout their stimulation cycles with assessments occurring two to three weeks after the start of treatment. Researchers will measure total hormone dosages, number of oocytes retrieved, mature oocytes, embryos formed, and quality of embryos. Pregnancy rates will be evaluated one month after the first embryo transfer. The trial includes over 100 infertile women undergoing IVF, with careful tracking of treatment outcomes and safety throughout the study period.

Researchers are conducting an observational study to improve understanding of the menstrual cycle and various gynecologic health conditions such as polycystic ovary syndrome (PCOS), infertility, and breast cancer. This study focuses on reproductive health and menstrual patterns in women and aims to gather long-term data to describe these aspects epidemiologically. The study is hosted on the Apple Research app, which participants can use to find, enroll in, and take part in this research. It collects data related to menstrual cycle patterns and the prevalence of gynecologic health conditions over a period of up to 10 years. Participants will engage through the app, providing information about their menstrual cycles and health conditions. The study tracks menstrual cycle patterns and collects epidemiologic data over time, also determining the prevalence of related health issues. This observational approach allows long-term monitoring without administering treatments. The study is expected to continue through November 2029.

Female fertility can be affected by several factors including ovarian function, fallopian tube health, the uterine environment, and mental state, with the ovaries and endometrium playing key roles. Common reproductive diseases impacting fertility include ovarian dysfunction, poor ovarian response, intrauterine adhesion, recurrent implantation failure, and thin endometrium. These conditions currently lack effective treatments, and platelet-rich plasma (PRP) shows promise, prompting further research into its effects and mechanisms. This study evaluates the use of platelet-rich plasma injections delivered via transvaginal or laparoscopic methods for ovarian diseases such as premature ovarian insufficiency and poor ovarian response. For uterine diseases including intrauterine adhesion, thin endometrium, and repeated implantation failure, PRP is administered through intrauterine perfusion or injections under the endometrium. The study focuses on monitoring the safety of PRP treatment up to three months post-enrollment. Participants are female patients aged 18 to 50 years diagnosed with one of the specified reproductive diseases. Their progress will be tracked through assessments of adverse and serious adverse events from enrollment through the three-month treatment period. Researchers will evaluate the safety of PRP injections and collect data to better understand its potential therapeutic effects in reproductive medicine.