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Infertility clinical trials

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NCT ID: NCT05421364 Not yet recruiting - Female Infertility Clinical Trials

Effects of Intrauterine Administration of Autologous PBMC on the Endometrial Cells Populations

Start date: July 9, 2022
Phase: N/A
Study type: Interventional

The behaviour of the endometrium during its receptive phase is highly dependent on the endometrial cell type composition. Each cell type has its role in the endometrial preparation for the invading embryo. Alteration in the immune cells dialogue could be the main reason for unsuccessful implantation in certain patients. Immune cell homeostasis is often improved by intrauterine administration of autologous PBMC. There have been numerous reports on the positive effects of the intrauterine administration of autologous PBMC on the IVF outcomes (embryo implantation and ongoing pregnancy success). However, there is little data on the direct effect of the PBMC administration on the cell composition of the endometrium. This study will focus on the changes in the endometrial cell populations by PBMC treatment that could lead to IVF outcome improvement. The aim of this project is to analyze the effect of intrauterine administration of autologous PBMC on the endometrial cell populations and on the IVF outcome parameters (implantation and ongoing pregnancy success as IVF outcome variables).

NCT ID: NCT05421234 Active, not recruiting - COVID-19 Clinical Trials

Effect of COVID-19 on Platelet Mitochondrial Bioenergetic, Antioxidants and Oxidative Stress in Infertile Men.

COVInfertility
Start date: April 1, 2022
Phase: N/A
Study type: Interventional

To verify the hypothesis that infertility and the effect of SARS-CoV-2 on infertility may damage platelet mitochondrial bioenergetics and endogenous coenzyme Q10 levels in infertile men.

NCT ID: NCT05419921 Recruiting - Clinical trials for Tubal Factor Infertility

Comparison of the Diagnostic Accuracy of Hysterosalpingo-lidocaine-foam Sonography Versus Hysterosalpingography in Tubal Patency Assessment to the Gold Standard of Laparoscopy and Dye Testing

Start date: July 1, 2022
Phase:
Study type: Observational

This is a cross-sectional study that compares the diagnostic accuracy of Hysterosalpingo-lidocaine-foam sonography combined with power doppler (HyLiFoSy-PD) in the assessment of tubal patency, with the diagnostic accuracy of hysterosalpingogram (HSG), and to the gold standard of laparoscopy and dye testing.

NCT ID: NCT05418140 Not yet recruiting - Infertility Clinical Trials

Adenomyosis and Pregnancy Outcomes in Women Undergoing Assisted Reproductive Technology Treatment

AdAPT-ART
Start date: June 10, 2022
Phase:
Study type: Observational

Rationale: A rising number of adenomyosis cases are being diagnosed in women in the age group of 30 to 40 years. This is due to a combination of better diagnostic imaging techniques and a higher number of women delaying the fulfilment of their fertility aspirations. The association between adenomyosis and pregnancy outcomes in women with subfertility has not been adequately explained by existing evidence due to lack of data on the association between the severity of adenomyosis, disease location, presence of symptoms and coexisting gynaecological conditions and pregnancy loss in women undergoing fertility treatment. There is a need to improve our understanding of prognostic features which would be beneficial in counselling women with adenomyosis undergoing fertility treatment and inform future management options. The investigators propose a research body of work aimed at improving our understanding of adenomyosis and its association with pregnancy loss. Objective: The aim of the study is to determine the association between adenomyosis and pregnancy loss in women undergoing assisted reproductive technology (ART) treatment. Study design: Prospective multicentre cohort study. The cohort will comprise of women with adenomyosis undergoing ART treatment and the control group will include women with normal uterus on baseline ultrasound scan undergoing ART treatment during the study duration. Settings: The study will be conducted at all main CARE fertility units, one of the largest providers of fertility treatment in the United Kingdom. Participant population with exposure and sample size: The cohort group will comprise of women diagnosed with adenomyosis on pre-treatment baseline ultrasound scan before ART treatment who satisfy the eligibility criteria and consent to participate in the study. The total sample size for this study will be 750 participants with 375 women in each arm. Recruitment will take place over the course of 18 months. Diagnostic tool for detection of exposure: The diagnosis of adenomyosis will be made using transvaginal ultrasound scan (TVS) (2D and 3D Ultrasound and applying Morphological Uterus Sonographic Assessment (MUSA) criteria. Schematic mapping system of adenomyosis severity proposed by Lazzeri and colleagues will be used to grade the severity of adenomyosis. Eligibility: Inclusion criteria: All women aged >18 years and ≤42 years undergoing IVF/ICSI cycle. Exclusion criteria: Women with coexisting fibroid uterus, endometrioma confirmed on USS or known laparoscopic diagnosis of endometriosis (with histological confirmation), untreated hydrosalpinx, uterine malformation, previous myomectomy, previous surgery for adenomyosis or inconclusive USS. Recruitment: All women undergoing pre-treatment pelvic ultrasound scans before ART treatment will be screened for adenomyosis at the participating centres. Women who meet the eligibility criteria will be provided with an information leaflet about the study. They will be enrolled in the study after informed consent is obtained. The severity of adenomyosis will be subsequently evaluated using stored 2D and 3D ultrasound scan (USS) images. Several demographic, clinical and treatment characteristics will be recorded for each participant. Control: To ensure adequate comparability of the cohort, women with normal uterus on baseline ultrasound scan during the study duration will be used as control and will be matched for the following variables: age, embryo quality, type of ART cycle (donor or self and IVF or ICSI) and number of embryos transferred. The eligibility criteria will be applicable to the controls as well. Outcome measures: Primary outcome: Pregnancy loss up to 24 weeks out of all pregnancies achieved. The pregnancy loss will include biochemical pregnancy loss, miscarriage, pregnancy of unknown location (PUL) and ectopic pregnancy. This will be reported per embryo transfer and per woman. Secondary outcomes:1. Implantation rate per embryo transfer (number of gestational sacs divided by number of embryos transferred) and per woman; 2. Biochemical pregnancy rate per embryo transfer (positive pregnancy test following embryo transfer) and per woman; 3. Clinical pregnancy rate per embryo transfer (presence of at least one intrauterine gestational sac on ultrasound) and per woman; 4. Ongoing pregnancy rate per woman (defined as a live pregnancy at 12 weeks onwards); 5. Live birth rate after 34 weeks per woman. Subgroup analysis: We will carry out subgroup analysis according to specific patient characteristics. These analyses will include, but not necessarily be limited to women with the following characteristics:1. Varying severity of adenomyosis; 2. Presence /absence of symptoms of adenomyosis; 3. Frozen vs. Fresh embryo transfer; 4. Short vs. long vs. ultralong ovarian stimulation protocol; 5. Recurrent miscarriages; 6. Other associations that may become apparent in post-hoc analyses.

NCT ID: NCT05413629 Active, not recruiting - Infertility, Female Clinical Trials

The Effect of Web Based Education on the Level of Coping With Infertility Stress and Infertility Self-Efficacy

education
Start date: March 1, 2022
Phase: N/A
Study type: Interventional

In the study, it is aimed to reduce the infertility stress level of women undergoing infertility treatment, to increase the level of coping with infertility stress, to increase infertility self-efficacy, to evaluate the usability of web-based education in the field of infertility, to increase the effectiveness and quality of education by integrating web-based education into the nursing care process, and continuous traceability, to prevention of possible wrong treatment process management in the field of infertility, to prevention of possible loss of cycles and to prevention the material and moral couple from being adversely affected by this process. Method: The study was planned to be carried out between 20.01.2022 and 01.06.2023 with women between the ages of 23-39 who applied to Düzce University Health Practice and Research Center, Infertility Polyclinic. In the research, the Solomon four-group design sample design consisting of two experimental and two control groups will be used. The study planned to consist of a total of 132 patients, 33 patients in each group, taking into account possible data losses. By design, all of the pre-test and post-test measurement tools will be applied to the first experimental and control group, and only the post-test measurement tools will be applied to the second experimental and control group. Randomization will be applied in determining the experimental and control groups. The data will be collected using Personal Information Form (Appendix-1), Infertility Stress Scale (ISS) (Appendix 2), Coping with the Infertility Stress Scale (CISS) (Appendix-3), and Infertility Self-Efficacy Scale - Short Form (ISE-SF) (Appendix 4). Research data will be collected in approximately day 24 to 27 days for each patient from the initiation of Controlled Ovarian Stimulation (COS) treatment to pregnancy determination of patients planned for intrauterine insemination (IUI) treatment. Web-based training is 60 minutes in total, including 4 modules. The web-based training content includes general information about fertility, infertility diagnosis-treatment methods, drugs used in IUI treatment and its application, and issues to be considered after IUI.

NCT ID: NCT05412147 Not yet recruiting - Infertility, Female Clinical Trials

The Effect of RECO-18 on Infertile Women Undergoing in Vitro Fertilization-embryo Transfer

Start date: July 2022
Phase: N/A
Study type: Interventional

How to improve the fertility of infertile women has become a hot topic in the field of assisted reproduction. Animal experiment has shown that RECO-18 significantly improved the female fertility in mice, and the specific mechanism was related to reducing follicular atresia, promoting follicle development and improving oocyte quality. Therefore the investigators aim to conduct a pilot study to explore the effect of RECO-18 in infertile women undergoing assisted reproduction treatment. This study is a prospective, randomized, controlled clinical study. The treatment group takes RECO-18 while the control group takes the multi-vitamins. The primary indicator is the ongoing pregnancy rate at 12 weeks' gestation; the secondary indicators are the number of oocytes retrieved, the normal fertilization rate and the rate of high quality embryos, implantation rate, clinical pregnancy rate, and early miscarriage rate.

NCT ID: NCT05410782 Not yet recruiting - Infertility, Male Clinical Trials

Power Prenatal Supplements for Sperm Quality

Start date: June 15, 2022
Phase: N/A
Study type: Interventional

Male factor infertility is a leading cause of primary and secondary infertility. Poor sperm quality is defined as having an abnormal semen analysis [WHO 2020 - https://www.who.int/publications/i/item/9789240030787]. The effects of supplements (vitamins, minerals, and anti-oxidants) on improving sperm quality are still debated (https://pubmed.ncbi.nlm.nih.gov/30462179). Taking additional supplements to improve sperm quality represent a modifiable risk-factor that would be an easy intervention for patients struggling with male factor infertility. The life cycle of sperm production is estimated at 3 months, so any intervention would require a 3 month course to see its full effect. We hypothesize that a 90 day course of the "Power Prenatal for Sperm", a male fertility supplement by Bird&Be (https://birdandbe.com/the-power-prenatal-for-sperm) will improve sperm quality based on semen analysis results prior to, and after taking the supplements.

NCT ID: NCT05404464 Active, not recruiting - Infertility Clinical Trials

Construction of CITIC Xiangya Assisted Reproduction Data Repository

CXARDR
Start date: January 1, 2016
Phase:
Study type: Observational [Patient Registry]

Human Assisted Reproductive Technology (ART) has become a very effective and nearly irreplaceable clinical treatment for infertility, helping millions of women achieve fertility. However, ART may still have potential health risks to mothers and offspring. To better research and monitor the efficacy and safety of ART, the investigators established CXARDR based on the real medical data in Reproductive and Genetic Hospital of CITIC-Xiangya, which is the world's largest ART single treatment center. CXARDR covers the ART full-cycle treatment records since the hospital perfected its electronic medical record system in 2016, as well as biological samples from the CITIC-Xiangya Genetic Resource Bank. From the preoperative investigation of ART to the 1-year follow-up of ART offspring, CXARDR provides the details of the whole process of treatment and the follow-up outcomes of ART patients, making up for the gap in the data of reproductive and obstetric institutions. The huge biological samples with clinical information also provide more possibilities for in-depth basic researches in the field of reproduction and genetics. During the past five years (January 2016 to November 2020), the CXARDR has accumulated data concerning more than 223,000 ART treatment cycles from 120,000 infertile couples. The CXARDR also links more than 180,000 blood samples, 65,000 follicular fluid samples, 80,000 semen samples, and 31,000 granulosa cell samples from 75,000 couples. The data volume is substantial with over 800 variables being documented, and most variables are designed as structured fields. The whole process of data access, data extraction, data processing and data analysis was conducted through a dedicated server inside the CITIC-Xiangya Data Center. All investigators cannot access sensitive information, are required to sign data confidentiality agreement, and need to be approved by the CITIC-Xiangya Ethics Committee.

NCT ID: NCT05403476 Not yet recruiting - Clinical trials for Male Idiopathic Infertility

A Trial to Compare Efficacy and Safety of Follitropin Delta Versus Placebo (Inactive Treatment) in the Treatment of Men With Idiopathic Infertility (Unexplained Reduction of Semen Quality) (ADAM)

Start date: July 15, 2022
Phase: Phase 2
Study type: Interventional

The primary purpose of this trial is to investigate whether men with idiopathic infertility (unexplained reduction of semen quality), after being treated with a daily dose of 12 µg recombinant follicle stimulating hormone (rFSH) for 6 months, can improve the chance of spontaneous pregnancy observed in their female partners in comparison to placebo (inactive treatment).

NCT ID: NCT05402800 Recruiting - Sexual Dysfunction Clinical Trials

Sexual Dysfunction in Infertile Women With PCOS Undergoing Fertility Treatment

Start date: January 1, 2022
Phase:
Study type: Observational

Infertility, defined as the inability to become pregnant after one year of regular unprotected sexual intercourse. It is estimated that around 20 % of couples suffer from infertility with prevalence rates of infertility differing substantial among countries . Sexual function in females is very complex and is affected by many factors. The prevalence of sexual dysfunction is higher in infertile patients compared to the normal population . Whether sexual dysfunction is the cause or consequence of subfertility is difficult to establish. For instance, sexual dysfunction might result in decreased coital frequency compounding the issue of subfertility due to reduced exposure. On the other hand, the psychological pressure to get pregnant stemming from sex on demand could result in a reduction in enjoyment of sex aggravating sexual dysfunction. Indeed, situational sexual dysfunction and loss of a couple's intimacy may occur as a consequence of timed intercourse where focus for coitus is no longer pleasure but conception .