Female Infertility

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.

This research aims to evaluate a gender-transformative intervention designed to reduce intimate partner violence (IPV) against infertile women. It focuses on couples diagnosed with female-factor infertility undergoing their first or second IVF or ICSI cycle. The trial addresses the overlap between infertility and IPV, recognizing that infertile women face higher risks of IPV and that their needs have often been overlooked. Participants are randomly assigned to one of two groups. The intervention group receives five 60-minute sessions led by trained nurses and social workers throughout the fertility treatment cycle. These sessions cover gender norms, gender equality, and healthy relationship skills at key treatment stages: before the cycle starts, during follicular monitoring, before oocyte retrieval, two weeks after embryo transfer, and 28-30 days post-transfer. The control group receives standard reproductive care. A total of 376 couples will participate, split evenly between the two groups. During the study, couples will undergo assessments at baseline and multiple points up to about 14 months after delivery. Researchers will measure the rate of IPV against infertile women over the past 12 months as the primary outcome. Secondary assessments include IPV against male partners, attitudes toward gender roles, marital quality, coping with stress, patient satisfaction with treatment, pregnancy outcomes, and neonatal health. This comprehensive follow-up includes questionnaires, clinical pregnancy tests, and monitoring of birth outcomes to understand the intervention's impact over time.

Premature ovarian insufficiency (POI) occurs when ovarian function declines in women before age 40, significantly affecting health and quality of life. This research aims to better understand the causes, progression, and health impacts of POI, as well as evaluate hormone replacement therapy (HRT) options. The study will create a hospital-based, multi-center case-control and prospective cohort to gather comprehensive data on POI's natural course and effects. The study includes several groups: women diagnosed with POI, control women with regular menstrual cycles, those scheduled for ovarian surgery, and those undergoing oophorectomy. Participants provide biological samples, lifestyle and health information, and undergo long-term follow-up assessments. Data collection spans multiple health factors including reproductive hormones, bone density, psychological well-being, and metabolic markers. Participants will be monitored at regular intervals up to 36 months with tests such as bone density scans, hormone level checks, blood glucose and insulin measurements, and psychological assessments for anxiety and depression. The study also tracks symptoms related to low estrogen and sexual health. Safety and health outcomes are observed through blood counts, liver and kidney function tests, and ultrasound exams. This comprehensive approach aims to deepen understanding and support improved care for women with POI.

This research aims to compare two oxygen concentration protocols—constant 5% versus sequential 5%-2%—used during embryo culture in assisted reproductive technology. The study focuses on women undergoing blastocyst transplantation to evaluate differences in term live birth rates and offspring health, including potential effects on telomere length, which is linked to aging and health outcomes. The trial is conducted across five centers, including the Clinical Center of Reproductive Medicine at the First Affiliated Hospital of Nanjing Medical University. Participants are randomly assigned to one of two groups: one receives embryo culture under a constant 5% oxygen concentration, and the other under a sequential protocol reducing from 5% to 2%. Both groups follow their respective blastocyst culture protocols during in vitro fertilization or intracytoplasmic sperm injection cycles. The study monitors outcomes related to live births and health status of offspring associated with each oxygen protocol. Women enrolled in the trial will be followed for three years, during which live birth rates, clinical pregnancy rates, implantation rates, miscarriage rates, and ectopic pregnancy rates will be recorded. Researchers will also assess offspring health by measuring peripheral blood telomere length. Evaluations include monitoring pregnancy outcomes and any perinatal complications. Data will be statistically analyzed to determine the effects of oxygen concentration protocols on reproductive success and offspring well-being.

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 investigating the outcomes after transferring a mosaic embryo, which contains both normal and abnormal chromosomal cells, in women undergoing in vitro fertilization (IVF) with preimplantation genetic testing (PGT). This prospective study aims to understand if transferring these embryos results in successful pregnancies and healthy live births, as some studies have suggested. The research focuses on implantation rates and live birth rates to determine if mosaic embryos should be routinely offered for transfer to patients experiencing infertility. Participants will undergo a single transfer of a mosaic embryo to the uterus after completing an IVF cycle with PGT at the Colorado Center for Reproductive Medicine. PGT involves testing a small number of cells from the embryo before transfer. Embryos identified as mosaic are usually not transferred as standard practice, but this study evaluates their potential for successful pregnancy. The study does not use a placebo or comparison group. Women in the study will be monitored through multiple follow-up periods after embryo transfer. Researchers will assess implantation rates 3 to 4 weeks after transfer and track live birth rates up to 9 to 12 months later. Additional outcomes include miscarriage rates, pregnancy complications, stillbirth rates, prenatal testing results, and neonatal outcomes up to 15 months after birth. Participants will have various clinical evaluations and tests as part of their routine care during the study period, which lasts up to about a year after embryo transfer.

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.

Researchers are investigating whether producing sperm after a very short abstinence period of just 1 hour can improve the rates of embryos with normal chromosomes during in vitro fertilization (IVF) treatment. The study aims to compare this ultrashort abstinence with the current standard abstinence period of 2 to 5 days to see if it leads to better embryo quality and pregnancy outcomes. This research is focused on couples experiencing infertility, particularly male factor infertility, and is sponsored by UConn Health. Participants will provide two sperm samples on the day of egg retrieval: one after the standard 2-5 days of abstinence and another after only 1 hour of abstinence. Their eggs will be randomly divided into two groups, with half fertilized using sperm from the standard abstinence sample and the other half fertilized using sperm from the ultrashort abstinence sample. Both groups will be part of the IVF process involving insemination or injection of sperm into the eggs. The study will assess embryo chromosome normality and other IVF outcomes. During the study, participants will undergo egg retrieval and fertilization procedures, with close monitoring of embryo development. Researchers will evaluate the rate of chromosomally normal embryos within 2 to 4 weeks of the IVF cycle, as well as pregnancy rates after embryo transfer, fertilization rates, and blastulation rates. Participation lasts through these IVF cycle stages, with data collected to understand how sperm abstinence timing affects embryo quality and pregnancy chances.

This research aims to evaluate the effects of royal jelly major proteins (MRJPs) delivered as rose tablet candies on ovarian function and endometrial receptivity in women aged 20 to 45 with normal menstrual cycles. The study will explore how MRJPs influence female reproductive health, focusing on their role in improving fertility factors such as hormone levels, ovarian reserve, and the uterine lining's ability to support embryo implantation. It also seeks to determine the safety and potential clinical value of MRJPs for reproductive medicine. Participants will be randomly assigned to one of two groups: one receiving oral MRJPs candy containing 70% MRJPs freeze-dried powder, and the other receiving a placebo candy mainly composed of whey protein powder. Both groups will take one tablet twice daily for one menstrual cycle. The MRJPs candy uses patented technologies to ensure quality and stability of the active ingredients. The placebo group allows comparison to evaluate the specific effects of MRJPs. Throughout the trial, researchers will monitor hormone levels, including anti-Müllerian hormone, and assess endometrial receptivity from enrollment through the one-month treatment period. Various tests and measurements will be conducted to track ovarian function and hormonal changes. The study is conducted with ethical oversight and scientific rigor to protect participants and ensure reliable results, with total participation lasting about one menstrual cycle plus screening and follow-up.

Researchers are evaluating the efficacy and safety of the Bushen Yiqi formula combined with dehydroepiandrosterone (DHEA) in treating women with diminished ovarian reserve (DOR). This study aims to determine whether this combined therapy can improve ovarian reserve, hormone levels, ovarian follicle characteristics, and clinical symptoms, while also assessing potential safety concerns. The trial compares the combined treatment to DHEA plus a placebo to see if the combination offers better results. Participants will be randomly assigned to one of two groups: one receiving DHEA combined with the Bushen Yiqi formula and the other receiving DHEA with a placebo. Both treatments are given orally for 12 weeks. The Bushen Yiqi formula is a granulated herbal mixture taken twice daily, while DHEA tablets are taken three times daily. The placebo is designed to look and taste like the herbal formula to maintain blinding. During the study, participants will undergo regular clinical assessments including measurement of ovarian reserve markers like AMH and antral follicle count, sex hormone levels (FSH, LH, E2, testosterone), traditional Chinese medicine symptom scores, menopausal index scores, inflammatory markers (CRP and IL-6), and safety evaluations. Blood samples for AMH will be collected at specific menstrual cycle days before treatment, after treatment, and after a 3-month follow-up. The total participation period includes treatment and follow-up assessments to monitor outcomes and safety.