Assessing Ketorolac (Toradol) at Oocyte Retrieval
InfertilityInfertility4 moreTo determine if a nonsteroidal anti-inflammatory drug (NSAID), Ketorolac (Toradol), can improve pain control and decrease narcotic use after undergoing egg retrieval.
Virtual Reality for Acute Pain and Anxiety During Egg Retrieval for in Vitro Fertility Treatment...
InfertilityIn Vitro Fertilization2 moreThis study is a comparison between the current standard practice of performing a transvaginal oocyte retrieval (TVOR) with paracervical block (PCB) and a relatively recently developed technology of virtual reality that is added to the above mentioned standard practice of TVOR + PCB. The aim of the study is to find out whether this newer technology has an advantage for the patient, in terms of anxiety and pain reduction or satisfaction.
Evaluation of Ovarian Morphology and Function in Overweight Women During Weight Loss
Weight LossAnovulation2 moreThe objective of this study is to explore the effects of weight loss on body composition, metabolic status, reproductive hormones, and ovarian follicle development in obese women with regular menstrual cycles versus obese women with irregular menstrual cycles and/or polycystic ovary syndrome (PCOS).
Feasibility Trial of the TELL Tool Intervention
Fertility IssuesDisclosure1 moreA radical paradigm shift is taking place where technology, notably the explosion in easy accessible direct-to-consumer genetic testing (e.g., 23andMe) and a high consumer interest in genealogy (e.g., Ancestry.com), has hijacked gamete (eggs, sperm) and embryo donation recipient parents' control over whether to inform their children about their donor conception. Historically, the practice of gamete donation has been shrouded in secrecy, however, the skyrocketing use of direct-to-consumer genetic testing means that at any point in an adult life, an uninformed donor-conceived person can learn their DNA does not match their presumed ancestry of their parents and family members, putting into question their genetic relatedness to their parents and launching a spiraling sequence of negative health consequences and trauma. Furthermore, the lack of one's knowledge about actual genetic heritage in the age of precision medicine can be enormously detrimental to health and can result in medical maltreatment, including death. To address this serious problem and in accordance with International Patient Decision Aid Standards, we developed a digital, tailored, multicomponent Tool to Empower ParentaL TeLling and Talking (i.e., TELL Tool). The objective of this R34 study is to examine the feasibility, acceptability, and preliminary effects of the TELL Tool intervention in a pilot randomized-controlled feasibility trial with 60 donor-recipient parents and 10 clinicians to determine intervention viability and inform a larger, efficacy trial. An eBook with content about good parenting principles serves as the attention control.
Determination of Vaginal Colonization and the Effect of an Oral Probiotic (PROSALVAG)
Microbial ColonizationDysbiosis1 moreThe aim of this study is to determine the efficacy of an oral nutraceutical with probiotics in restore vaginal health.
Heated and Non Heated Ovarian Aspiration Needle Protocol
InfertilityFemaleThe success of IVF is influenced by factors as cause of infertility and age. Furthermore, there is a large influence of external factors, from the laboratory environment, handling and cultivation of gametes and embryos. The existence of factors capable of affecting the success of the treatment lead to the need of a quality control to attenuate the unfavorable effects. After ovarian stimulation, follicular aspiration is performed. At this moment, factors such as aspiration technique, needle type and temperature are the main variables to be controlled. It is known that oocytes are the more sensitive cells to temperature fluctuations. Currently, the standard protocol for follicular aspiration does not include the warming of the aspiration needle. However, due to the existing evidence in the literature, that the follicular fluid temperature drops during the aspiration procedure, this work aims to evaluate the influence of a pre warming of the aspiration needle as a new protocol.
Quality of Human Embryos in IVF, Culturing in Differentiated Oxygen
InfertilityIVF1 moreThe goal of this clinical trial is to evaluate the importance of differential O2 tension to the developing embryos. As a secondary aim, we investigate the levels of reactive oxygen species (ROS) in spent media from the developing blastocysts. This is a prospective, interventional multicenter study using sibling embryos. Woman (age 18-41 and normal weight) undergoing assisted reproductive technology (ART) can be included in the study. Patients included in the project will follow standard IVF protocol and treatment. By retrieving ≥ 8 oocytes after pickup and upon prior acceptance by the patient, she/the couple can be included in the study. According to standard treatment, both groups of oocytes will be placed in an incubator with 5% O2.After 3 days of cultivation, the dishes with the study-embryos will be transferred to an incubator with 2% O2. The control embryos will remain in the conventional 5% O2 incubator. On the fifth day, the embryos will be evaluated, and the blastocyst with expected greatest implantation potential will be transferred to the patients uterus. Surplus embryos with expected implantation potential will be cryopreserved. After transfer or cryopreservation, the media from the wells with used blastocysts will be collected and stored for ROS analysis. Value for public Health: If our hypothesis is confirmed, we will be able to optimize the developmental conditions and decreased ROS levels for the embryo in vitro. From a clinical perspective, this could affect the implantation rate of the blastocyst and thus the success of pregnancies for infertile couples while reducing the number of treatments to obtain a viable pregnancy.
Mild Stimulation Protocol Using Clomiphene Citrate for Women With PCOS Undergoing in Vitro Fertilization...
PCO - Polycystic OvariesInfertilityInfertility is of increasing significance affecting almost 48.5 million couples around the world. Anovulation is a major cause of infertility in women with polycystic ovary syndrome (PCOS) accounting for about 80% of women with anovulatory infertility. Ultrasound morphological features of PCOS include the presence of 16 or more follicles measuring 2-9 mm in diameter, and/or an overall large ovarian volume of >10mm3. Women with PCOS ultrasound features exhibit an exaggerated response to controlled ovarian stimulation. Controlled ovarian hyperstimulation is an established prerequisite to assisted reproductive techniques with the aim of obtaining a higher yield of oocytes and ultimately increasing success rates. According to the ESHRE/ASRM consensus on infertility treatment related to polycystic ovary syndrome, IVF seems to represent a reasonable treatment option as the risks of multiple pregnancies and ovarian hyper-stimulation syndrome may be kept to a minimum. The optimal stimulation protocol however is still debatable. Recently, patient-friendly stimulation protocols for assisted reproductive technology were introduced aiming at minimizing overall treatment costs and health hazards to the patient. Mild stimulation protocols are considered relatively novel protocols. They consist of combining oral stimulation agents (clomiphene citrate or letrozole) with low-dose gonadotropins as effective alternatives to conventional gonadotropin-only stimulation protocols. Mild stimulation protocol has been associated with better tolerance, ease of use, and comparable livebirth outcomes. The investigators aim to test the hypothesis that mild stimulation protocols could produce a similar proportion of term livebirths to conventional treatment, while reducing treatment costs and health hazards. This is a prospective non-randomized controlled trial comparing a mild ovarian stimulation protocol to conventional treatment for assisted reproductive technology at the Division of Reproductive Endocrinology and Infertility - Haifa Idriss Fertility Center - American University of Beirut Medical Center.
In Vitro Fertilisation Versus Intracytoplasmic Sperm Injection in Patients Without Severe Male Factor...
InfertilityOver recent decades, the use of intracytoplasmic sperm injection (ICSI) has increased, even among patients without severe male factor infertility. Despite the increasing use, there is no evidence to support that ICSI results in a higher live birth rate compared to conventional in vitro fertilisation (IVF) in cases without severe male factor infertility. The primary objective of this trial is to determine whether ICSI is superior to standard IVF in patients without severe male factor infertility. The primary outcome measure is live birth rate. A total of 824 participants with infertility without severe male factor will be included in the study and allocated randomly into two groups (IVF or ICSI). The main inclusion criteria for the women are age 18-42 years, normal to slightly decreased male partner sperm/ use of donor sperm and no prior fertility treatment. In addition to live birth rate, outcome measures include fertilisation rate, total fertilisation failure, embryo quality, clinical pregnancy, miscarriage rate, preterm delivery, birth weight and congenital anomalies of the child. The study will be performed in accordance with the ethical principles in the Helsinki Declaration. The study is approved by the Scientific Ethical Committee of the Capital Region of Denmark and the Knowledge Centre on Data Protection Compliance. Study findings will be presented in international conferences and submitted for publication in peer-reviewed journals.
Oral Versus Vaginal Progesterone for Luteal Phase Supplementation in Frozen Embryo Transfer Cycles...
Frozen Embryo TransferHormone Replacement Therapy3 moreTo investigate the efficacy of dydrogesterone 30 mg compared to micronized vaginal progesterone 800 mg daily for luteal phase support in hormone replacement therapy frozen embryo transfer cycles, as confirmed by visualization of fetal heart activity by pelvic ultrasound assessment of ongoing pregnancy at 12 weeks of gestation.