Clinical Research Directory

Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele

Pregnant women, irrespective of their pregnancy risk, who undergo a cesarean section for any reason will be randomized to one of two suturing techniques: conventional suture or barbed suture for uterine repair after the cesarean section. Following surgery, these patients will be followed up for clinical outcomes, ultrasound evaluation of the uterine scar, and study of the hypoxic-inflammatory environment of the uterine cavity.

Mobile Health Application for Fertility-Related Stress and Healthy Lifestyle in Women With Infertility

The goal of this clinical trial is to learn whether a Turkish-language mobile health application (Umay) can reduce fertility-related stress and improve healthy lifestyle behaviours in women diagnosed with infertility who are receiving care at in vitro fertilisation clinics. The main questions it aims to answer are: * Does using the Umay application for eight weeks lower fertility-related stress? * Does using the application improve health-promoting lifestyle behaviours? * Do women find the application easy to use and acceptable? Researchers compared the Umay application with a printed infertility information booklet containing the same information. Participants: * Used the Umay application (short videos on infertility and treatment, healthy lifestyle and stress management, a daily activity plan, yoga and meditation content, and three daily reminder notifications) or read the printed booklet, for eight weeks, alongside routine clinical care. * Completed questionnaires on fertility-related stress (Fertility Problem Inventory) and lifestyle (Health-Promoting Lifestyle Profile II) at the start and after eight weeks. * In the application group, also completed a usability questionnaire after eight weeks.

Biorepository in Participants Who Undergo OTC for Gonadotoxic Therapy

Background: Medical advances have improved survival rates for many cancers and other illnesses. This means that more people are coping with the long-term effects of these treatments. Some treatments can cause female infertility. Ovarian tissue cryopreservation (OTC) may help. Before undergoing a treatment that may damage their fertility, patients may opt to freeze a sample of ovarian tissue. The tissue contains immature egg cells. When thawed, the tissue can be reimplanted. This procedure can help women become pregnant. Objective: This natural history study will create a databank of ovarian tissue. The NIH will provide OTC as a clinical service. The NIH will also request a portion of the tissue to use for research. Eligibility: Females aged 4 to 35 who opt to have OTC before receiving cancer treatment. Design: Participants will be screened. Their existing medical records will be reviewed. They will be asked if they want to donate a portion of their ovarian tissue for research. No more than 20% of the tissue collected will be taken for research. Some other tissues that would otherwise be discarded will also be kept. Medical data from each participant may also be collected and stored in the database. This data may include results of routine blood tests, imaging tests, and other information. The data will be coded for privacy. Participants will answer a questionnaire. They will be asked about their fertility treatment and general health. The survey takes about 30 minutes. They will repeat the questionnaire once a year for 30 years.

The Effectiveness of CPII for Infertility Induced by PCOS in China

Polycystic ovary syndrome (PCOS) is a common endocrine disorder in women of reproductive age and is associated with metabolic, reproductive and mental health complications. Its prevalence has been reported to be between 5% and 15% in different studies, showcasing its significant impact on the reproductive health of Chinese women. A holistic approach to PCOS treatment that integrates physical, emotional, and mental health is lacking in China. The integration of counseling and personalized care into existing healthcare frameworks may have economic implications on patients with PCOS-induced infertility. This study aimed to compare the effectiveness of the counselling, personalized care, and counseling-personalized care-integrated interventions versus the current module on the clinical outcomes over six months among patients of PCOS-induced infertility. The primary outcomes are menstrual cycle, hormonal parameters, metabolic parameters, and biochemical pregnancy. The secondary outcomes include anxiety and depression, sleep quality, and patient satisfaction. This study also explored the perceived challenges and barriers among patients with PCOS-induced infertility and healthcare providers involved in counseling-personalized care-integrated interventions in China. The mixed-method sequential interpretative design was applied. The quantitative component involved a non-randomized controlled trial. A total of 192 patients were recruited by convenient sampling from reproductive medicine centers of four hospitals in Shandong Province. One hospital implemented each module. Data has been collected through a review of medical records and questionnaires. Descriptive statistical and repeated measure analysis of variance has been applied using SPSS version 28.0. The qualitative component involved the phenomenological approach of in-depth interviews of patients and healthcare providers involved in the counseling-personalized care-integrated interventions. Approximately 36 respondents were invited for online interviews via purposive sampling. A thematic analysis has been performed using Nvivo version 14.

Hormonal Regulation of Puberty and Fertility

Background: \- The body produces gonadotropin-releasing hormone (GnRH) about every 2 hours. GnRH travels through the bloodstream to the pituitary gland, where it stimulates the gland to produce hormones called gonadotropins. These hormones stimulate the testicles or ovaries. The testicles produce testosterone and develop sperm. The ovaries produce estrogen and prepare for ovulation. Normal estrogen and testosterone levels are required for puberty. Some people, however, have either low levels or total lack of GnRH. This can cause problems with puberty and fertility. Researchers want to study people with low or no GnRH to better understand how it affects puberty and fertility. Objectives: \- To study disorders of GnRH production. Eligibility: * Adult men and women at least 18 years of age with low or no gonadotropin levels. * Adolescents between 14 and 18 years of age with low or no gonadotropin levels. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. * Participants will have tests to look at their hormone levels. Blood samples may be collected after taking different drugs, including insulin and cortisone. A 24-hour urine sample will be collected. * Participants will have imaging studies to look at bone and brain development. They will also have ultrasounds of the kidneys, abdomen, and reproductive organs. * Tests of smell and hearing will be used to look for abnormalities in these senses.

Fresh Versus Vitrified-Warmed Donor Oocytes: Embryological and Clinical Outcomes

This multicenter retrospective observational study compares embryological and clinical outcomes following treatment with fresh versus vitrified-warmed donor oocytes at Bocian Fertility Clinic centers in Poland. The study focuses on a standardized allocation strategy in which recipients are intended to receive six mature (metaphase II, MII) donor oocytes. In the vitrified-warmed group, oocytes are cryopreserved at the MII stage and subsequently warmed for use. Oocytes lost during warming are not routinely replaced, allowing the study to evaluate the consequences of warming-related losses within the initial allocation. The study will assess fertilization, embryo development, usable blastocyst yield, the probability of obtaining an embryo for transfer, and live birth following the first embryo transfer originating from the allocated oocytes. Clinical effectiveness will be evaluated from the initial oocyte allocation, including cycles in which no embryo transfer occurs. The objective is to determine whether fresh and vitrified-warmed donor-oocyte strategies are associated with differences in embryological efficiency and the likelihood of live birth when the initial number of mature allocated oocytes is standardized.

Vitamin D and Polycystic Ovarian Syndrome (PCOS)

Primary Objectives: To evaluate the efficacy of metformin and Vitamin D supplementation on serum insulin and serum androgen levels (Total testosterone, Steroid Hormone Binding Globulin, Free Androgen Index) levels compared metformin alone in infertile Poly cystic ovarian females of reproductive age group. Secondary Objectives: To measure change in endometrial thickness/number of follicles and follicular size by day 12 trans-vaginal ultrasound in the intervention group i.e. combination of metformin and vitamin D supplementation

A Study to Compare the Efficacy and Safety of Follitropin Alfa/Lutropin Alfa Versus hMG in Japanese Participants With LH and FSH Deficiency Undergoing ART (HINATA)

The purpose of this study is to assess the efficacy and safety of follitropin alfa/lutropin alfa in Japanese participants with Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) deficiency undergoing Assisted reproductive technology (ART). The study duration is approximately 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy in Part A.

Safety and Efficacy of Corifollitropin Alfa N02 Injection in Elderly Women Undergoing Assisted Reproductive Technology (ART)

This is a multi-centre, single-arm, observational trial to assess the safety and efficacy of corifollitropin alfa N02 Injection in elderly Chinese women undergoing ART, and then to explore the compliance and satisfaction during COS treatment.

Automation of the In Vitro Fertilization Laboratory

Enrolled patients will undergo an Assisted Reproductive technology (ART) treatment using intracytoplasmic sperm injection (ICSI, the direct injection of a single sperm cell into an oocyte) as the method of insemination. In this prospective cohort study, patients' sperm, eggs, and embryos will be processed using an automated system called AURA (Conceivable Life Sciences), which consists of five subsystems. Specifically, sperm samples will be prepared for fertilization using the subsystem C:SPERM. Cumulus-oocyte complexes (COCs) containing the oocytes will be isolated from follicular fluid using the subsystem C:EGG. One out of every four COCs will be removed from the AURA system at random and processed according to the local treatment clinic's standard operating procedure. All other COCs will continue automated procedures and will be denuded, fertilized, incubated, and vitrified using the AURA subsystems C:EGG. C:ICSI, C:CULTURE and C:VIT, respectively. All automated procedures will be conducted under the supervision of a laboratory manager, who can intervene, address any potential anomalies, and override any steps undertaken by the automated AURA system. The study aims to deliver a descriptive evaluation of the AURA system, including assessing the device's performance, defined by its level of automation, efficiency, and throughput. As a secondary objective, the study aims to characterize the clinical performance of each of AURA's subsystems and correlate this performance against pre-established benchmarks in a non-inferiority statistical analysis. Finally, the study seeks to collect technical data related to AURA's hardware and software operation.

Implementing IVM for Fertility Treatment in Clinical Practice

The ovarian reserve consists of a finite pool of follicles that gradually declines throughout a woman's reproductive life. During conventional IVF, exogenous gonadotropins are administered for 10-14 days to support the growth and maturation of multiple follicles, followed by induction of final oocyte maturation before oocyte retrieval. In vitro maturation (IVM) offers an alternative approach in which immature oocytes are retrieved from small antral follicles and matured in the laboratory within 24-44 hours. IVM requires no or only minimal ovarian stimulation and may therefore reduce treatment burden, costs, side effects, and the risk of ovarian hyperstimulation syndrome (OHSS). Recent advances in the retrieval of oocytes from small antral follicles, together with improved understanding of the molecular mechanisms regulating human oocyte maturation, have renewed interest in IVM and improved its clinical potential. The overall aim of this project is to implement and optimize IVM as a clinical fertility treatment in Denmark. Specifically, we aim to: (1) evaluate the clinical success rates of IVM compared with conventional IVF; (2) characterize molecular differences between in vivo- and in vitro-matured oocytes and resulting blastocysts, as well as between follicular cells from small antral and preovulatory follicles; and (3) use new insights into the regulation of human oocyte maturation to optimize IVM protocols and improve treatment outcomes. Ultimately, the project aims to establish IVM as a safe, effective, and less burdensome alternative to conventional IVF for selected patient groups.

Inherited Reproductive Disorders

Background: \- During puberty, children begin to develop into adults. Problems with the hormones released during puberty can affect the reproductive system. Some people have low hormone levels that severely delay or prevent puberty. Others start puberty abnormally early. Other people may have a normal puberty but develop reproductive disorders later in life. Researchers want to study people with reproductive disorders to learn more about how these disorders may be inherited. Objectives: \- To learn how reproductive system disorders may be inherited. Eligibility: * People with one of the following problems: * Abnormally early puberty * Abnormally late or no puberty * Normal puberty with hormonal problems that develop later in life * People who have not yet had puberty but have symptoms that indicate low hormone levels. Design: * Participants will provide a blood sample for testing. They will complete a questionnaire about their symptoms. They will also have a scratch-and-sniff test to study any problems with their ability to smell. * Participant medical records will be reviewed. Participants will also provide a family medical history. * Family members of those in the study may be invited to participate. * Treatment will not be provided as part of this study.

GnRH for Luteal Support in IVF/ICSI/FET Cycles

During IVF cycles an embryo is generally placed into the uterine cavity between 3 and 5 days after fertilization. For a successful pregnancy to take place, that embryo must then implant in the properly primed and staged endometrium, which subsequently must continue to develop to accommodate the growing and maturing embryo and then fetus. This process is normally regulated by hormonal interactions between the fetal, endometrial and luteal tissue. It has been found that after IVF additional support for the endometrium with progesterone improves implantation and subsequent live birth rates in IVF cycle . Recent data has shown that additional supplementation with a single administration of a GnRH agonist around the time the time of embryo transfer may further enhance these rates .

Aurora Test for ART Donor Patients (AURORA-Donor)

This is a randomized observational study. The main aim is to determine potential oocyte competence predictive mRNA expression profiles in the cumulus cells isolated form individual oocytes. In 2 patient cohorts: 1)GnRH Antagonist \& hr-FSH with GnRH Agonist trigger, 2) Progesterone \& hr-FSH with GnRH Agonist trigger.

The Efficacy of Remimazolam on Incidence of Hypoxia During Sedated Transvaginal Oocyte Retrieval

Hypoxia is the most common adverse reaction during sedation outside the operating room.Exploring novel drug combinations to reduce the incidence of hypoxia during sedation in patients undergoing transvaginal oocyte retrieval procedures enhances patient safety and lowers perioperative adverse event rates. This multicenter, prospective, randomized, controlled clinical study will compare the hypoxia incidence rate of the remimazolam-alfentanil combination against the commonly used propofol-alfentanil combination.

Use of Pulsatile Intravenous FSH to Mitigate Reprometabolic Syndrome

Hypothesis: The investigators hypothesize that pulsatile FSH intravenous administration to women with obesity will correct the Reprometabolic Syndrome (RMS) luteal deficiency phenotype. Specific Aim: To test the hypothesis that pulsatile IV administration of FSH will rescue the impaired folliculogenesis and relative hypogonadotropic hypogonadism, characteristic of obesity. This study will also try to rescue the diminished ovarian reserve phenotype in the same fashion. The investigators will accomplish this by administering a cycle of pulsatile FSH to women with obesity and comparing their hormone output to a cycle using conventional, daily FSH injection at the identical daily dose. The primary outcome will be luteal phase progesterone excretion.

Ovarian Reserve Testing in Female Young Adult Cancer Survivors

Young adult cancer survivors constitute an under served population to whom fertility potential is particularly important. For female young adult patients, cancer treatment such as alkylating chemotherapy are toxic to the finite number of eggs they have, resulting in risks of infertility and premature menopause related to ovarian failure. Reproductive issues are a major concern for young cancer survivors, but one that is understudied. Young cancer survivors have few tools to measure post-treatment ovarian reserve, or the quantity and quality of remaining eggs4. Accurate determination of ovarian reserve and fertility potential would not only be an important research tool, but also directly impact clinical management. The purpose of this study is to test if basal and provocative ovarian reserve testing can predict return of menses in female young adult cancer survivors, to compare basal and provocative ovarian reserve testing results between female young adult cancer survivors and healthy controls, and to compare basal and provocative ovarian reserve testing results between female young adult cancer survivors on and off of combined estrogen and progesterone hormone products. Participants will be asked to keep track of their periods over three months. If a participant is taking birth control pills, patches, or vaginal ring, they will asked to come off the birth control for 3 months. Participants will also be asked to undergo ovarian reserve testing by blood draws and pelvic ultrasounds at the start and end of the 3 months.

Effect of Recombinant Follicular Stimulating Hormone (FSH) Dosing Following Cori-follitropin Alfa

In the trial, women planned to be treated with 150μg corifollitropin alfa followed by rFSH in a fixed GnRH antagonist protocol will be asked to participate and sign the ICF. Corifollitropin alpha treatment will be initiated at D2-D3 of the cycle. Patients who need additional r-FSH following corifollitropin-alfa will be randomized on day 8 of the stimulation into 3 study groups. In group A, B and C, ovarian stimulation with Corifollitropin alfa (Elonva®, MSD) will be used for ovarian stimulation, followed by 50IU (Group A), 150IU (Group B) or 250IU (Group C) of recFSH (Puregon®, MSD).

Intra-ovarian CAPA-IVM vs Standard IVM

This prospective study compares two approaches to obtaining mature oocytes for fertility treatment within the same participant. Immature oocytes are first retrieved from the right ovary and matured in the laboratory using a two-step biphasic capacitation in vitro maturation method (CAPA-IVM). Beginning on Day 5 of the same menstrual cycle, the left ovary undergoes minimal controlled ovarian stimulation followed by routine oocyte retrieval and IVF/ICSI. The primary objective is to evaluate the maturation of CAPA-IVM oocytes to the metaphase II (MII) stage and compare reproductive laboratory outcomes between the CAPA-IVM and minimal-stimulation OS-IVF approaches. Secondary outcomes include fertilization, embryo development, blastocyst formation, embryo quality, pregnancy and live birth outcomes, and safety.

Fast Track to Fertility

The Fast Track to Fertility (FTF) program is an algorithmic text messaging communication and patient education platform designed to improve the efficiency the fertility workup. The initial pilot program resulted in an approximately 50% reduction in the time taken to complete the diagnostic workup. Since the pilot program, the investigators have enhanced the FTF Program (v2.0) beyond the texting platform, incorporating educational videos to increase patient knowledge and autonomy in the workup and treatment of infertility. This protocol pertains to a randomized controlled quality improvement initiative to measure the impact of the FTF v2.0 Program on fertility workup completion, efficiency, and patient outcomes.

Impact of a Predetermined Day 5 ET vs. a Predetermined Day 6 ET on Clinical Pregnancy Rate After ICSI Treatment

The aim of this prospective multicenter study is to investigate the influence of a predetermined embryo transfer on day 6 compared to a predetermined embryo transfer on day 5. The study population consists of the control group (predetermined embryo transfer on day 5) and the study group (predetermined embryo transfer on day 6). The primary endpoint is the clinical pregnancy rate (detection of a gestational sac) per embryo transfer and the secondary endpoint is the abortion rate per clinical pregnancy. The data from the multicenter study are obtained at three test centers (Fertility Center Dortmund, Fertility Center Essen and Fertility Center Bad Münder).

Prospective, Multi-centre, Non-Interventional Study to Investigate the Effectiveness of REKOVELLE® for Ovarian Stimulation for Asian Women in Real World Settings

Primary objective is to investigate the effectiveness of REKOVELLE® in women undergoing their first REKOVELLE® ovarian stimulation treatment in real world practice in Asian countries.

Inositol in Letrozol Resistant PCOS Women

Polycystic ovary syndrome (PCOS),is a complex neuro-endocrine disorder affecting approximately 5% to 10% of women in reproductive age.Inositols are considered insulin sensitizers, as they modulate the members of insulin signaling pathways.Thiss study compares between the effect of inositol and metformin in letrozol resistant PCOS women.

Artificial Intelligence in Embryo Selection in Assisted Reproduction for Embryos Cultured to the Fifth Day of Development

Embryo selection is one of the major challenges in Assisted Reproductive Technology (ART) in order to continuously improve clinical pregnancy rates. Morphological evaluation of embryos is the standard method used to assess embryo quality and to select the embryo to be transferred. However, this observational method has limitations: it can be subjective and may lead to inter- and intra-observer variability. To increase pregnancy rates, the transfer of two embryos may be proposed, which can result in high-risk multiple pregnancies. Despite the introduction of time-lapse systems and embryo selection algorithms aimed at increasing live birth rates, outcomes in ART remain suboptimal and can still be improved. The use of artificial intelligence (AI) is expanding in the medical field and is increasingly being applied in ART laboratories to optimize outcomes while avoiding multiple pregnancies. EMA™ is a secure artificial intelligence software platform developed by the company AiVF. The use of this software could allow a standardized and reproducible evaluation of embryo development up to the fifth day of embryonic culture. Through the application of an algorithm, the software may enable the selection of the embryo with the highest potential for achieving pregnancy. The primary objective of this study is to evaluate the use of the EMA™ artificial intelligence system in embryo selection for embryos cultured up to day 5, in comparison with the morphokinetic criteria currently used in the laboratory for the first fresh transfer of a day-5 embryo. The secondary objectives are to assess whether artificial intelligence (1) reduces the time to achieve pregnancy (defined as pregnancy achieved or not after the first transfer of a day-5 embryo) and (2) affects the miscarriage rate among patients treated in the ART CECOS unit. A medico-economic analysis will be conducted to evaluate the number of new patients undergoing an additional treatment attempt and to determine whether there is a correlated reduction in time to pregnancy by assessing the number of pregnancies achieved after the first transfer in patients already under treatment. A cost-effectiveness analysis will also be performed, comparing the cost-effectiveness ratios between the two study arms.