International Journal of Fertility & Sterility最新文献

{"title":"An Approach to Improve Endometrial Receptivity: Is It Beneficial to Flush The Uterine Cavity with Follicular Fluid and Granulosa Cells? A Phase III Randomised Clinical Trial.","authors":"Elham Hosseini, Samaneh Aghajanpour, Zahra Chekini, Nadia Zameni, Zahra Zolfaghary, Reza Aflatoonian, Maryam Hafezi","doi":"10.22074/ijfs.2023.2000897.1461","DOIUrl":"10.22074/ijfs.2023.2000897.1461","url":null,"abstract":"<p><strong>Background: </strong>The follicular fluid (FF) of mature oocytes contains a high concentration of growth factors and cytokines that have the potential to influence implantation in either a paracrine or autocrine manner. During the physiological processes of ovulation, FF enters the fallopian tubes in conjunction with the oocyte. The purpose of this study is to evaluate implantation and clinical pregnancy rates following uterine flushing with FF and granulosa cells in infertile women with moderate male factor infertility after ovum retrieval for intracytoplasmic sperm injection (ICSI).</p><p><strong>Materials and methods: </strong>This phase III randomised clinical trial enrolled 140 women with moderate male factor infertility who intended to undergo ICSI at Royan Infertility Clinic (Tehran, Iran). A computer-generated program and opaque sealed envelopes were used to randomly allocate patients to either an intervention group (n=70) or a control group (n=70). Participants in the intervention group received 2 ml of clear FF (without blood contamination) from 2 to 3 dominant follicles after oocyte retrieval. The control group only underwent uterine cavity catheterisation.</p><p><strong>Results: </strong>The intervention group had a clinical pregnancy rate of 38.5% (25/65) compared to the control group [42.9% (27/63); P=0.719] and an implantation rate of 24.1% compared to the control group (27%; P=0.408). These rates did not differ between the groups. There were no statistically significant differences between the intervention and control groups in terms of pregnancy-related complications-ectopic pregnancy, blighted ovum or anembryonic pregnancy, and abortion.</p><p><strong>Conclusion: </strong>Uterine cavity flushing with FF from mature follicles following oocyte retrieval had no effect, either positively or negatively, on clinical pregnancy or implantation rates in women with moderate male factor infertility (registration number: NCT04077970).</p>","PeriodicalId":14080,"journal":{"name":"International Journal of Fertility & Sterility","volume":null,"pages":null},"PeriodicalIF":2.3,"publicationDate":"2024-07-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11263849/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141734080","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Can We Harvest More Mature Oocytes by Repeating Gonadotropin-Releasing Hormone Agonist Doses in Polycystic Ovarian Syndrome Patients at Risk of OHSS in Antagonist Cycles? A Randomised Clinical Trial.","authors":"Seyedeh Houra Hashemi, Maryam Hafezi, Arezoo Arabipoor, Maryam Zareei, Samira Vesali, Poopak Eftekhari-Yazdi","doi":"10.22074/ijfs.2023.2008905.1513","DOIUrl":"10.22074/ijfs.2023.2008905.1513","url":null,"abstract":"<p><strong>Background: </strong>There is an ongoing debate about the optimal dosage of gonadotropin-releasing hormone (GnRH) agonist for oocyte triggering in polycystic ovarian syndrome (PCOS) patients at risk for ovarian hyperstimulation syndrome (OHSS). In this study, we intend to ascertain whether the use of repeated doses of a GnRH agonist for oocyte triggering in these patients can enhance the outcomes of controlled ovarian stimulation (COS) for <i>in vitro</i> fertilization/ intracytoplasmic sperm injection (IVF/ICSI) cycles.</p><p><strong>Materials and methods: </strong>This randomised clinical trial enrolled 70 PCOS women candidates for IVF/ICSI with the standard antagonist protocol at Royan Institute (Tehran, Iran) from May 2020 to June 2022. Patients at risk of OHSS with oestradiol (E2) levels >3000 pg/ml on the day of trigger were randomly assigned to a control or experimental group. Group A (control group) patients received 0.2 mg triptorelin (Decapeptyl^®) for final oocyte maturation. Group B (experimental group) patients received a second dose of 0.1 mg Decapeptyl^®12 hours after their first dose, for a total dose of 0.3 mg. IVF/ICSI outcomes were compared between the groups.</p><p><strong>Results: </strong>Ultimately, 35 women from the study group and 33 from the control group completed the treatment cycle. Both groups were comparable in terms of demographic characteristics, baseline hormonal profiles, and PCOS phenotypes. The dosage of gonadotropin, stimulation duration, number of retrieved oocytes, oocyte maturation rate, and oocyte recovery ratio did not significantly differ between the groups. No significant differences were found in terms of the number of blastocyst and cleavage embryos, nor the quality of obtained embryos between the groups. The mild to moderate OHSS rate was significantly lower in the study group (P=0.038).</p><p><strong>Conclusion: </strong>A second dose of GnRH agonist 12 hours after the first dose did not improve the number and maturity of oocytes, or pregnancy outcomes in PCOS patients (registration number: NCT04600986).</p>","PeriodicalId":14080,"journal":{"name":"International Journal of Fertility & Sterility","volume":null,"pages":null},"PeriodicalIF":2.3,"publicationDate":"2024-07-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11263846/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141734081","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Live Birth after Cleavage-Stage versus Blastocyst-Stage Embryo Transfer in Assisted Reproductive Technology: A Randomised Controlled Study.","authors":"Malihe Mahmoudinia, Behnaze Sovizi, Seyed Mohammad Reza Ebadi, Faezeh Zakerinasab, Tahereh Sadeghi, Mahbbobeh Mahmoudinia","doi":"10.22074/ijfs.2023.2000574.1463","DOIUrl":"10.22074/ijfs.2023.2000574.1463","url":null,"abstract":"<p><strong>Background: </strong>Blastocyst stage transfer appears to improve pregnancy outcomes. The aim of this study is to evaluate the pregnancy results between fresh cycle blastocyst stage embryo transfer and cleavage stage embryo transfer in patients who undergo intracytoplasmic sperm injection (ICSI).</p><p><strong>Materials and methods: </strong>This randomised clinical trial study was conducted at the Infertility Research Centre of Milad Hospital in Mashhad, Iran from 2018 to 2020 on 240 infertile women who presented for their first ICSI procedure. These patients were assigned to receive either cleavage embryo transfer (n=112) or blastocyst stage transfer (n=107). Pregnancy outcomes were measured in both groups.</p><p><strong>Results: </strong>There were no differences regarding age, body mass index (BMI), serum follicle-stimulating hormone (FSH), duration of infertility, and aetiology of infertility between the groups (P>0.05). There were more follicles, total oocytes, and metaphase II (M2) oocytes in the blastocyst stage group. Considerably more cleavage stage embryos were transferred compared to the number of transferred blastocysts (P=0.001). The blastocyst group had more vitrified embryos than the cleavage group (P=0.000). The rates of implantation (P=0.332), chemical pregnancy (P=0.165), clinical pregnancy (P=0.694), and live births (P=0.727) were higher in the blastocyst group, but they were not significantly different. The rate of abortion was also not significantly higher in the blastocyst group (P=0.296).</p><p><strong>Conclusion: </strong>Blastocysts transferred in the fresh cycle of an ICSI procedure may be more advantageous compared to cleavage stage embryo transfer (registration number: IRCT20181030041503N1).</p>","PeriodicalId":14080,"journal":{"name":"International Journal of Fertility & Sterility","volume":null,"pages":null},"PeriodicalIF":2.3,"publicationDate":"2024-07-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11263845/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141734086","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of Testicular Platelet-Rich Plasma (PRP) Injection on Sperm Parameters in Men with Severe Oligoasthenoteratozoospermia (OAT): A Clinical Evaluation.","authors":"Faezeh Fazli, Hossein Torkashvand, Ali Reza Soltanian, Ali Babalhavaeji, Hanieh Olomi, Shamim Pilehvari","doi":"10.22074/ijfs.2024.2011066.1535","DOIUrl":"10.22074/ijfs.2024.2011066.1535","url":null,"abstract":"<p><strong>Background: </strong>Severe oligoasthenoteratozoospermia (OAT), characterized by a reduced sperm count, motility, and altered morphology, presents a significant challenge in the field of male infertility. Platelet-rich plasma (PRP), renowned for its regenerative capabilities, emerges as a potential intervention for this condition. This study aims to explore the impact of PRP on male infertility, focusing specifically on individuals with severe OAT.</p><p><strong>Materials and methods: </strong>The clinical trial study involved 88 infertile men diagnosed with OAT and devoid of underlying diseases. These participants were referred to the infertility center and subsequently divided into two cohorts: a control (44 individuals) and an intervention group (44 individuals). Patients in the intervention group received 2 cc of PRP in each testicle, prepared by centrifuging the patients autologous blood samples. Sperm parameters and DNA fragmentation index (DFI) of the patients were measured before and after the procedure. Statistical analysis used SPSS version 16 software, with a significance level set at less than 5%.</p><p><strong>Results: </strong>The statistical analysis revealed a significant difference in concentration (11.32 ± 8.44 vs. 16.06 ± 15.16, P=0.030), progressive motility (8.86 ± 7.79 vs. 11.97 ± 11.82%, P=0.014) and DNA fragmentation (25.62 ± 12.84 vs. 17.23 ± 9.15%, P<0.001) between the control and intervention groups after PRP injection. However, no significant difference was found in normal morphology (1.63 ± 1.44 vs. 1.81 ± 3.68%, P=0.628) and volume (2.13 ± 0.82 vs. 2.24 ± 1.43, P=0.663) between the control and intervention groups after PRP injection.</p><p><strong>Conclusion: </strong>This study demonstrates the effectiveness of PRP treatment in increasing sperm concentration and motility, while also reducing sperm DNA fragmentation. However, further studies are needed to validate these findings (registration number: IRCT20220317054318N2).</p>","PeriodicalId":14080,"journal":{"name":"International Journal of Fertility & Sterility","volume":null,"pages":null},"PeriodicalIF":2.3,"publicationDate":"2024-07-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11263848/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141734083","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Effect of Uterine Length Measurement before Embryo Transfer versus Transabdominal Ultrasound-Guided Embryo Transfer on FET Cycle Outcome: A Randomised Clinical Trial.","authors":"Fereshteh Bahrami, Maryam Eftekhar, Nasim Tabibnejad","doi":"10.22074/ijfs.2023.2000790.1460","DOIUrl":"10.22074/ijfs.2023.2000790.1460","url":null,"abstract":"<p><strong>Background: </strong>Embryo transfer (ET) is an important step in assisted reproductive technology. Uterine length measurement before ET (ULMbET) enables the determination of catheter length and anatomical variation before the ET. Therefore, in this study, we aim to compare ULMbET and transabdominal ultrasound-guided ET (TAUGET).</p><p><strong>Materials and methods: </strong>This open-label randomised clinical trial enrolled 264 women who were scheduled for frozen- thawed ET (FET) cycles. The women were randomised to the ULMbET or TAUGET group for ET. The primary outcome of this study was clinical pregnancy.</p><p><strong>Results: </strong>A total of 132 women were randomly assigned to the ULMbET group and 132 women to the TAUGET group. However, four women in the ULMbET group did not receive the allocated method after randomisation. Finally, 128 women from the ULMbET group and 132 women from the TAUGET group were assessed. No statistically significant differences existed in chemical pregnancy rate (31.3 vs. 36.4%, P=0.384), clinical pregnancy rate (23.4 vs. 28%, P=0.397), and implantation rate (15 vs. 17.8%, P=0.401) between the ULMbET and TAUGET groups, respectively.</p><p><strong>Conclusion: </strong>The results of this clinical trial show no differences in pregnancy outcomes in FET cycles following ULMbET and TAUGET (registration number: IRCT20110509006420N240).</p>","PeriodicalId":14080,"journal":{"name":"International Journal of Fertility & Sterility","volume":null,"pages":null},"PeriodicalIF":2.3,"publicationDate":"2024-07-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11263847/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141734100","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Hysteroscopic Endometrial Fundal Incision versus Hysteroscopy Only in Oocyte Recipients: A Randomized Controlled Trial Assessing The Reproductive Outcomes.","authors":"Nikolaos Peitsidis, Ioannis Tsakiridis, Robert Najdecki, Georgios Michos, Ioannis Kalogiannidis, Apostolos Athanasiadis, Evangelos Papanikolaou","doi":"10.22074/ijfs.2024.2009369.1523","DOIUrl":"10.22074/ijfs.2024.2009369.1523","url":null,"abstract":"<p><strong>Background: </strong>Endometrial scratching (ES) remains controversial regarding its potential effectiveness in improving pregnancy rates. The objective of the present study was to assess the impact of endometrial fundal incision (EFI) during hysteroscopy on reproductive outcomes in a population of oocyte recipients.</p><p><strong>Materials and methods: </strong>A randomized controlled trial was conducted between 2020 and 2023 at the Third Department of Obstetrics and Gynecology, School of Medicine, Faculty of Health Sciences, Aristotle University of Thessaloniki and \"Assisting Nature Centre of Reproduction and Genetics\". The study population consisted of women who underwent hysteroscopy randomly assigned in a 1:1 ratio to either EFI (one to three months before embryotransfer with donor oocytes) or no intervention throughout office hysteroscopy. Clinical pregnancy and live birth rates were the primary outcomes.</p><p><strong>Results: </strong>After the exclusion of patients with intraoperative diagnosed endometrial pathology, a total of 124 women underwent randomization. The pregnancy test was positive in 79% (n=49/62) of the women in the EFI compared to 59.7% (n=37/62) in the hysteroscopy-only group (P=0.019), while the live birth rates did not differ between the two groups (58.1%, n=36/62 vs. 51.6%, n=32/62, P=0.470).</p><p><strong>Conclusion: </strong>EFI during hysteroscopy seems to improve pregnancy rates in oocyte recipients without intrauterine pathology, while live birth rates are not affected by the EFI. These results should be interpreted with caution before the implementation of EFI in the routine in vitro fertilization (IVF) practice (registration number: NCT04580056).</p>","PeriodicalId":14080,"journal":{"name":"International Journal of Fertility & Sterility","volume":null,"pages":null},"PeriodicalIF":2.3,"publicationDate":"2024-07-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11263851/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141734084","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Effect of Adding Daily 50 mg Intramuscular Progesterone to 800 mg Progesterone Suppository on The <i>In Vitro</i> Fertilization Success Rate in Women with Low Progesterone Levels: A Clinical Trial Study.","authors":"Mahbod Ebrahimi, Firoozeh Akbari Asbagh, Fatemeh Davari Tanha, Fatemeh Amirkhanloo, Ghazal Sahraiyan, Elham Feizabad, Sara Lotfi","doi":"10.22074/ijfs.2023.2008438.1506","DOIUrl":"10.22074/ijfs.2023.2008438.1506","url":null,"abstract":"<p><strong>Background: </strong>A low progesterone level on the embryo transfer (ET) day significantly reduces the pregnancy rate. Therefore, the present study aims to investigate the effect of adding daily 50 mg intramuscular progesterone to a total of 800 mg progesterone suppository on the <i>in vitro</i> fertilization (IVF) success rate in women with low progesterone levels.</p><p><strong>Materials and methods: </strong>This parallel open-label clinical trial was performed on 218 IVF candidate infertile women who had <9.2 ng/ml progesterone levels on the ET day. These women were randomised to the intervention or control group using the randomisation allocation rule. In the intervention group, 50 mg progesterone was prescribed intramuscularly once daily in addition to 400 mg of progesterone suppository every 12 hours from the day of ET. The control group received only 400 mg of progesterone suppositories every 12 hours. In the case of pregnancy, the drugs above were continued until 12 weeks after the ET.</p><p><strong>Results: </strong>Clinical pregnancy occurred in 54 (50.0%) women in the intervention group and in 39 (36.8%) women in the control group, which was significantly different (P=0.035). Ongoing pregnancy occurred in 47 (43.5%) women in the intervention group, and 33 (31.1%) women in the control group, which was significantly different (P=0.042). There were no significant differences in terms of abortion and multiple pregnancy rates between the two groups.</p><p><strong>Conclusion: </strong>Intramuscular injection of 50 mg progesterone significantly increases the clinical and ongoing pregnancy rates (registration number: IRCT20150105020558N6).</p>","PeriodicalId":14080,"journal":{"name":"International Journal of Fertility & Sterility","volume":null,"pages":null},"PeriodicalIF":2.3,"publicationDate":"2024-07-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11263853/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141734099","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Improving Fertility in Non-obstructive Azoospermia: Results from an Autologous Bone Mar-row-Derived Mesenchymal Stromal/Stem Cell Phase I Clinical Trial.","authors":"Rano Zhankina, Ulanbek Zhanbyrbekuly, Manarbek Askarov, Afshin Zare, Nazanin Jafari, Dana Saipiyeva, Ravil Sherkhanov, Daniyar Akhmetov, Alireza Hashemi, Mojtaba Farjam, Nader Tanideh, Behrouz Aflatoonian, Nadiar Maratovich Mussin, Asset Askerovich Kaliyev, Yerlan Sultangereyev, Hanieh Baneshi, Reza Shirazi, Mahdi Mahdipour, Shabnam Bakhshalizadeh, Farhad Rahmanifar, Amin Tamadon","doi":"10.22074/ijfs.2023.2005045.1480","DOIUrl":"10.22074/ijfs.2023.2005045.1480","url":null,"abstract":"<p><strong>Background: </strong>In this phase I clinical trial, our primary objective was to develop an innovative therapeutic approach utilizing autologous bone marrow-derived mesenchymal stromal/stem cells (BM-MSCs) for the treatment of nonobstructive azoospermia (NOA). Additionally, we aimed to assess the feasibility and safety of this approach.</p><p><strong>Materials and methods: </strong>We recruited 80 participants in this non-randomized, open-label clinical trial, including patients undergoing NOA treatment using autologous BM-MSCs (n=40) and those receiving hormone therapy as a control group (n=40). Detailed participant characteristics, such as age, baseline hormonal profiles, etiology of NOA, and medical history, were thoroughly documented. Autotransplantation of BM-MSCs into the testicular network was achieved using microsurgical testicular sperm extraction (microTESE). Semen analysis and hormonal assessments were performed both before and six months after treatment. Additionally, we conducted an <i>in-silico</i> analysis to explore potential protein-protein interactions between exosomes secreted from BM-MSCs and receptors present in human seminiferous tubule cells.</p><p><strong>Results: </strong>Our results revealed significant improvements following treatment, including increased testosterone and inhibin B levels, elevated sperm concentration, and reduced levels of follicle-stimulating hormone (FSH), luteinizing hormone (LH), and prolactin. Notably, in nine patients (22.5%) previously diagnosed with secondary infertility and exhibiting azoospermia before treatment, the proposed approach yielded successful outcomes, as indicated by hormonal profile changes over six months. Importantly, these improvements were achieved without complications. Additionally, our <i>in-silico</i> analysis identified potential binding interactions between the protein content of BM-MSC-derived exosomes and receptors integral to spermatogenesis.</p><p><strong>Conclusion: </strong>Autotransplantation of BM-MSCs into the testicular network using microTESE in NOA patients led to the regeneration of seminiferous tubules and the regulation of hormonal profiles governing spermatogenesis. Our findings support the safety and effectiveness of autologous BM-MSCs as a promising treatment modality for NOA, with a particular focus on the achieved outcomes in patients with secondary infertility (registration number: IRCT20190519043634N1).</p>","PeriodicalId":14080,"journal":{"name":"International Journal of Fertility & Sterility","volume":null,"pages":null},"PeriodicalIF":2.3,"publicationDate":"2024-07-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11263852/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141734085","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Efficacy and Safety of DLBS3233, A Combined Bioactive Fraction of <i>Cinnamomum burmanii</i> and <i>Lagerstroemia</i> speciosa Plants on The Endocrine-Metabolic Profile of Women with Polycystic Ovary Syndrome: A Randomized Clinical Trial.","authors":"Andon Hestiantoro, Wiryawan Permadi, Raymond R Tjandrawinata, Budi Wiweko, Mulyanusa Amarallah Ritonga, Ade Indra Ferrina, Kanadi Sumapraja, R Muharam, Tono Djuwantono","doi":"10.22074/ijfs.2023.551350.1283","DOIUrl":"10.22074/ijfs.2023.551350.1283","url":null,"abstract":"<p><strong>Background: </strong>A bioactive fraction of <i>Cinnamomum burmanii</i> and <i>Lagerstroemia</i> speciosa, DLBS3233, has recently been used for type-2-diabetes treatment due to its favorable effect on insulin sensitivity. The insulin resistance leading to metabolic syndrome is closely linked to hyperandrogenemia in polycystic ovary syndrome (PCOS). This study evaluated the metabolic and reproductive efficacy and safety of DLBS3233 in insulin-resistant PCOS women.</p><p><strong>Materials and methods: </strong>This was a 2-arm, randomized, double-blind, controlled, noninferiority clinical study over a 6-month therapy with DLBS3233 100-mg daily in comparison to metformin-XR 750 mg twice daily, involving 124 PCOS women with insulin resistance. The primary efficacy endpoint was the improvement of Homeostasis Model Assessment-Insulin Resistance (HOMA-IR). Secondary endpoints were improvements in other metabolic and reproductive parameters. Safety endpoints were based on blood pressure, heart rate, electrocardiogram findings, liver and renal function, and adverse events.</p><p><strong>Results: </strong>After 6 months, HOMA-IR improvement in DLBS3233-treated group (-1.03 ± 0.50) and metformin-XR (-1.19 ± 0.50) were comparable, with a between-group difference fell within the pre-set non-inferiority margin (0.16; 95% confidence interval (CI): -1.24, 1.56; P=0.3168). The HOMA-IR in both groups were significantly improved from baseline. On all secondary endpoints, both groups showed comparable effects. Markedly fewer adverse events occurred in the DLBS3233 treated group than in the Metformin-XR-treated group and most were mild clinically and had been resolved by the end of the study.</p><p><strong>Conclusion: </strong>Treatment with DLBS3233 100-mg daily in PCOS women demonstrated comparable efficacy to metformin- XR 750-mg twice daily in improving insulin resistance. However, the non-inferiority of DLBS3233 to metformin- XR remains inconclusive. DLBS3233 was more tolerable than metformin-XR (registration number: NCT01733459).</p>","PeriodicalId":14080,"journal":{"name":"International Journal of Fertility & Sterility","volume":null,"pages":null},"PeriodicalIF":2.3,"publicationDate":"2024-07-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11263850/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141734101","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical Trials for The Management of Infertility.","authors":"Babak Eshrati","doi":"10.22074/ijfs.2024.713736","DOIUrl":"10.22074/ijfs.2024.713736","url":null,"abstract":"<p><p>In the ever-evolving landscape of infertility science, clinical trials emerge as the cornerstone of progress. These trials, propelled by the unwavering dedication of scientific pioneers, serve as the bedrock for innovation and discovery in reproductive health. Through rigorous experimentation and meticulous analysis, they illuminate the path towards novel solutions for the complex challenges of infertility.</p>","PeriodicalId":14080,"journal":{"name":"International Journal of Fertility & Sterility","volume":null,"pages":null},"PeriodicalIF":2.3,"publicationDate":"2024-07-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11263843/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141734082","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}