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  • Comparison of Ovulation Induction Cycle Outcomes Between Early and Late Dose Increments for Low Dose Gonadotropin Step-up Protocol Among Infertile Women Diagnosed With Polycystic Ovary Syndrome: Prospective Randomised Trial

    Low dose gonadotropin step-up ovulation induction treatment is the universally accepted and utilized teratment protocol for infertile women diagnosed with polycystic ovary syndrome. First dose increment is advised on 14th day of ovarian stimulation with gonadotropins to decrease multiple follicle generation and cycle cancellation rates. However, clinicians impatiently increase gonadotropin dose on 7th day of stimulation without strong scientific evidence. This randomised controlled study will be the first study which will compare safety and ovulation induction cyle outcomes of early and late dose increments among infertile women diagnosed with polycystic ovary syndrome. We will start low dose step-up ovulation induction treatment by using 50 IU recombinant FSH for 21-39 years old non- obese patients (BMI <30 kg/m2) diagnosed with PCOS and . We will perform folliculometry on 7th day of ovulation induction. In case of absence for at least one >10 mm dominant follicle, we will randomise these women by using blind envelope selection method for assignment of early or late dose incerement groups. Half of the patients will receive 25 IU dose increment on 7th day of ovulation induction, remaining half will receive dose increment on 14th day of ovulation induction. We will continue ovarian stimulation without any other dose increment until 35th day of stimulation as deadline time restriction. We will perform folliculometry and serum estradiol measurement intermittently during ovulation induction. We will record ovulation induction cycle outcomes and clinical pregnancy results of the study group following finalization for treatment cyle of each patient. We will compare ovulation induction cycle outcomes of these two dose increment groups.

    Phase

    N/A

    Span

    105 weeks

    Sponsor

    Saglik Bilimleri Universitesi

    Recruiting

    Healthy Volunteers

  • IUI With Letrozole Versus in Natural Cycle

    Phase

    N/A

    Span

    196 weeks

    Sponsor

    Peking University Third Hospital

    Recruiting

  • Intracavernous Injection of Botox 100 U for Treatment of PDE5Is Inconvenient Patients With ED

    Background: Direct Intracavernosal injections of vasoactive agents to treat erectile dysfunction were first described in 1982 using papaverine. Later on many agents have been introduced for ICI. one of most newly introduced ICI agents for treatment of ED is Botulinum Toxin Type A. Purpose: The aim of this study will to compare the safety, efficacy, tolerability and adverse events s of ICI of BTX-A 100 unit in comparison with ICI Trimix in the treatment of Erectile Dysfunction for PDE5Is non-responders. Design, Settings, and Participants: This study will be conducted on 124 patients at minimum, complain of erectile dysfunction not responding to different PDE5Is therapy presenting to Urology department and outpatient clinic at Banha University Hospital. patients will be randomized into 2 equal groups: The treatment group A: will receive a single ICI of BTX-A 100 units . The treatment group B: will receive on-demand ICI of Trimix . Assessment for all groups will be done by Sexual Health Inventory for men (SHIM), Sexual Encounter Profile questions 2 and 3 (SEP 2 & SEP 3), and the global assessment question (GAQ) based on pre-treatment, 2 weeks, 3 months and every 3 months after treatment.

    Phase

    2/3

    Span

    191 weeks

    Sponsor

    Benha University

    Recruiting

  • Effect of Prophylactic Antibiotics for Hysterosalpingography on Post Procedure Morbidity

    Hysterosalpingography is a radiological procedure that outlines the female genital tract1. It is routinely done as part of work up for female infertility with the aim of identifying lesions that may cause female factor infertility1. It is considered as a minor gynaecological procedure2. The procedure involves exposing the cervix with a bivalve speculum and injecting a contrast medium through a cannula that is applied to the cervix. Images of the genital tract are then obtained by fluoroscopy. The lower genital tract is rich in micro flora. The natural milieu of the lower genital tract prevents infection. However, the upper genital tract is sterile. Microorganisms can ascend from the lower genital tract to the upper genital tract through the cervix and lead to infections. Infections of the upper genital tract can result in acute or chronic pelvic infection with subsequent chronic abdominal pain, ectopic pregnancy, menstrual irregularities and infertility as a result of inflammation and scarring of the fallopian tubes. Hysterosalpingography can lead to transcervical transmission of microorganisms from the lower genital tract to the upper genital tract. Cervical trauma during the procedure can facilitate ascending infection. Also, direct transcervical transfer of microorganisms from the lower genital tract to the upper genital tract can occur. Different approaches of preventing iatrogenic upper genital tract infection following hysterosalpingography exist. Prophylactic antibiotics can be given to all clients undergoing the procedure. On the other hand, prophylactic antibiotics may be limited to only those that have symptoms suggestive of genital tract infection based on their history. However, this may not suffice because some genital tract infections are mainly asymptomatic. Another approach is to screen all clients undergoing hysterosalpingography for genital tract infection and treat as necessary. Screening may also be limited to those with history suggestive of genital tract infection. This approach may also miss the clients with asymptomatic infections. Despite the possibility of iatrogenic upper genital tract infection following hysterosalpingography and availability of possible approaches in preventing such infection, there is no standard recommendation for the use of prophylactic antibiotics for hysterosalpingography2,3. Thinkhamrop et al conducted a review on prophylactic antibiotic for transcervical intrauterine procedures2. The procedures included the collection of endometrial tissue to assess the cause of abnormal uterine bleeding, hysterosalpingography for infertility evaluation, hysteroscopy for intrauterine cavity diagnosis and treatment, and the evacuation of conceptive products. They reported that there were no available randomized controlled trials on the subject matter to enable recommendations for the use of antibiotics for such procedures. This study aims at determining the effect of prophylactic antibiotic for Hysterosalpingography on post procedure morbidity. Specific objectives include determining the effect of prophylactic antibiotic for hysterosalpingography on post procedure febrile morbidity, infectious morbidity and need for antibiotic therapy. Effect on adverse effect of the antibiotics will also be reported. METHODOLOGY STUDY DESIGN The study will be a randomized controlled trial. STUDY AREA The study will be conducted at the departments of Obstetrics and Gynaecology and radiology Ahmadu Bello University Teaching Hospital, Zaria. The participants will be recruited from the departments of Obstetrics and Gynaecology and radiology, Ahmadu Bello University Teaching Hospital, Zaria, as they present for review and work up for infertility. Patients will be followed up for the outcome via mobile calls and outpatient gynaecology clinic attendance. STUDY POPULATION The study will comprise of women who present to the department of radiology Ahmadu Bello University Teaching Hospital, Zaria for hysterosalpingography as part of routine work up for infertility. SAMPLING APPROACH/RANDOMISATION A probability sampling method will be used. Simple random sampling using a computer generated table of random numbers will be used. The WINPEPI version 11.65 software was used to generate the table of random numbers. The numbers 001-156 will be randomly allocated to two groups A and B. Group A will be the study group and group B will be the control group (see appendix). Each number from the table of random numbers will be copied on separate paper and then sealed in a brown envelope. The envelopes will then be kept inside a box after shuffling. Each patient will be allocated to the group that the number she picks corresponds to on the computer printout. SAMPLE SIZE DETERMINATION: The sample size for each group was determined by using the statistical formula for comparison of proportions. Each group will be rounded up to 78. SAMPLING RECRUITEMENT: Women that fulfil the inclusion criteria will be counselled about the study in the departments of Obstetrics and Gynaecology. After obtaining a written consent, the consent form will be attached to the radiology request form for hysterosalpingography and they will be referred to the radiology departments. At the radiology departments, participants will be requested to pick one of the brown envelopes which will contain the randomization group. Group A will be the study group and will be given oral Doxycycline capsule 100mg bd for 5/7. She will be instructed to commence the medication on day 1 of her next menstrual cycle and hysterosalpingogram will be done within the proliferative phase of the same menstrual cycle after cessation of bleeding. Group B will be given oral multivitamin capsule i bd for 5/7. She will be instructed to commence the medication on day 1 of her next menstrual cycle and hysterosalpingogram will be done within the proliferative phase of the same menstrual cycle after cessation of bleeding. The clients will be contacted over the phone for follow up 24 hours after the procedure. They will also be requested to present to the emergency gynaecology unit in case they develop any symptom. All clients will be booked for routine follow up appointment in the gynaecology clinic two weeks after the procedure. The clients will also be given digital thermometers and taught how to use them in case they develop fever before they present to the emergency unit. DATA COLLECTION METHOD: A proforma will be filled for the participants. This will include Biodata, contact, details of their Sociodemographic and reproductive profiles. History of previous minor gynaecological procedures will also be obtained. ANALYTICAL APPROACH Data will be analysed using the statistical package for social sciences (SPSS) version 20.0. Chi-square test will be used to analyse categorical data and student t-test will be used to analyze continuous data. Logistic regression will be used to examine the influence of compounders. A p- value of less than 0.05 will be considered as significant. The primary and secondary outcomes will be analysed to determine any significant statistical differences. A p-value of less than 0.05 will be considered as significant. Relative risk (95% confidence level) will also be determined for every outcome. The socio-demographic characteristics, reproductive profile and history of previous minor gynaecological procedure will be analysed to determine whether there are any significant differences within the two groups which may affect the outcome of the study. Chi-square test will be used for categorical data and student t-test will be used for continuous data. If there is statistically significant difference in the characteristics of the participants, logistic regression will be used to eliminate the effect of these differences on the outcome of the study.

    Phase

    N/A

    Span

    155 weeks

    Sponsor

    Ahmadu Bello University Teaching Hospital

    Recruiting

    Healthy Volunteers

  • Sexual Dysfunction in Patients With Relapsing Remitting Multiple Sclerosis and Associated Comorbidities

    The present study is a cross sectional study on 120 MS adolescent patients meeting the McDonald's criteria; 60 male cases and 60 female cases recruited from Mansoura University Hospitals, Egypt. All patients were subjected to the following: 1. Clinical Evaluation: 1. Thorough neurological examination. 2. Cognitive functions by Minimental State Examination (MMSE). e. Expanded Disability Severity Scale (EDSS). 2. Neurophysiological Evaluation: a. Visual Evoked Potential (VEP). 3. Imaging Evaluation: a. Conventional MRI. 4. Cerebrospinal Fluid (CSF): 5. Sexual dysfunction measure: through the international index of erectile function (IIEF), female sexual function questionnaire (SFQ) and the sexual Quality of life male and female version (SQoL) (American Psychiatric Association, 1994). 6. Depressive symptoms assessment through The BDI (The Beck Depression Inventory) which is the most common instrument measuring the severity of depression. 7. Fatigue symptoms were evaluated through fatigue subscale of Multiple Sclerosis Quality of Life-54(MSQOL-54).

    Phase

    N/A

    Span

    30 weeks

    Sponsor

    Mansoura University Hospital

    Recruiting

  • Oral Dydrogesterone vs. Micronized Vaginal Progesterone for Luteal Phase Support in Frozen-thawed Embryo Transfer Cycles

    Phase

    4

    Span

    52 weeks

    Sponsor

    Memorial Sisli Hospital, Istanbul

    Recruiting

    Healthy Volunteers

  • Effect of ESWT on ED in Type 2 Diabetics

    ED in DM is often complex and caused by several mechanisms including vascular disease, autonomic neuropathy, hormonal imbalance, and psychogenic factors. However, as the endothelial dysfunction is an important factor contributing to the development of ED in diabetic patients, such patients can be resistant to phosphodiesterase 5 inhibitors (PDE5I) like sildenafil therapy. There are reports of lower efficacy of sildenafil in DM patients compared to general population.In the field of sexual medicine numerous studies have shown that ESWT is safe, noninvasive, and, most importantly, an effective method for treating vascular ED Before starting the study, clearance will be obtained from the institutional ethical committee and prior informed consent of all the participants will be obtained before conducting the study. Patients will be recruited from outpatient clinic of andrology (Cairo University Hospitals). The patients were randomly divided into two equal groups: Group (1): (Study group): Men in this group (n= 20) men receive extracorporeal shock wave (ESWT) twice weekly for 3 consecutive weeks and repeated after a 3-week rest period, for a total of 12 treatment sessions+sildenafil 5mg) Group (2): (Control group):) will receive sham treatment underwent identical therapy with ESWT application with a similar appearance and sound as the active low intensity ESWT+sildenafil 5mg

    Phase

    N/A

    Span

    37 weeks

    Sponsor

    Cairo University

    Recruiting

  • Comparing the Effect of Sitagliptin/Metformin and Metformin in PCOS Patients

    This study was conducted in Infertility clinic of Mahdiyeh Educational Hospital, Tehran. Patients in the four groups receive the drug 2 months before the start of the ovulation cycle, and treatment will continue until the day of the oocyte aspiration. The drug provide by midwife to patients and both patient and physician blind to the treatment regimen. The participants randomly divide into four groups.The ovulation induction stimulate with GnRh antagonist.

    Phase

    1/2

    Span

    81 weeks

    Sponsor

    Shahid Beheshti University of Medical Sciences

    Recruiting

  • Effect of Reproductive Tract Microbiota on Pregnancy Outcome in IVF/ICSI

    A single center,observational cohort study will enroll 120 infertile participants and then divide them into 3 groups: 1)Male infertility;2)Recurrent implantation failure; 3)Recurrent spontaneous abortion. The study will last for 1 year and recruit participants in Reproductive medicine center of Peking university third hospital. Each participant will be followed up for at least 1 year. Collect samples and record information at the first month, then follow-up 2 months to record the pregnancy outcomes. DNA will be extracted from the samples and then have sequence to figure out the compositions of microbiota.

    Phase

    N/A

    Span

    72 weeks

    Sponsor

    Peking University Third Hospital

    Recruiting

  • The Impact of Lifestyle on Sperm Telomere Length and Telomerase Activity in Men Undergoing IVF Treatments

    Following approval of the study by the Hospital Ethical Committee (Helsinki), semen samples and blood will be collected from infertile individuals referred to our IVF unit at Hillel Yaffe Medical Center. Informed written consent will be obtained from each participant. Standard semen analysis will be carried out according to World Health Organization protocol. An aliquot of semen sample will be used for assessment of sperm motility, concentration, and morphology by using computer-aided sperm analysis (CASA) and the remaining sample will be used for assessment of sperm telomere lengths and telomerase activity. Genomic DNA will be extracted from the remaining washed sperm and peripheral blood. Sperm telomere length will be determined by real-time polymerase chain reaction (qRT-PCR) and telomerase activity will be determined by TRAP assay (Telomeric Repeat Amplification Protocol).

    Phase

    N/A

    Span

    167 weeks

    Sponsor

    Hillel Yaffe Medical Center

    Recruiting

    Healthy Volunteers

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