scholarly journals Effectiveness of modified downregulation for women with moderate and severe adenomyosis of the uterus prior to frozen thawed embryo transfer (MODA) study protocol: a pragmatic randomised-controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (10) ◽  
pp. e050248
Author(s):  
Sania Latif ◽  
Bassel H Al Wattar ◽  
Neerujah Balachandren ◽  
Tomasz Lukaszewski ◽  
Ertan Saridogan ◽  
...  

IntroductionAdenomyosis can adversely reduce chances of pregnancy in couples undergoing assisted conception. We aim to evaluate the effect of two different downregulation protocols on the reproductive outcomes in women with moderate and severe adenomyosis undergoing frozen-thawed embryo transfer (FTET).Methods and analysisWe will conduct a two-armed pragmatic randomised clinical trial comparing modified downregulation with gonadotrophin-releasing hormone (GnRH) analogue for 6 weeks to standard downregulation with GnRH analogue for 1 week prior to FTET. Our primary outcome is clinical pregnancy, defined as a viable intrauterine pregnancy confirmed by ultrasound at greater than 6 weeks gestation, with other secondary reproductive, neonatal and safety outcomes. We aim to randomise 162 patients over 3 years to achieve 80% power for detecting a 20% difference in the primary outcome at 5% significance.Ethics and disseminationTo date there is no consensus on the optimal protocol for management of subfertile women with adenomyosis. Modified downregulation could improve the clinical pregnancy rate by reducing the endometrial inflammatory reaction and/or myometrial contractility and their impact on uterine receptivity in women with moderate and severe adenomyosis of the uterus undergoing FTET. The MODA trial is designed to offer pragmatic, real-life evaluation of the optimal protocol for downregulation for this population during assisted conception treatments. Our findings will be published in peer-reviewed journals and presented at national and international scientific meetings and congresses. Ethical approval was granted by the NHS Research Ethics Committees (19/LO/1567).Trial registration numberNCT03946722.

2021 ◽  
Author(s):  
ling CUI ◽  
Fang Wang ◽  
Yonghong Lin

Abstract Background: To assess the effect of intrauterine administration of seminal plasma for patients with recurrent implantation failure before frozen-thawed embryo transfer. Methods: Trial design: This is a parallel group, randomized (1:1 allocation ratio) controlled trial.Participants: All patients will be recruited from Chengdu Women’s and Children’s Central Hospital. Inclusion criteria: 1. Women after IVF/ICSI treatment in Chengdu Women’s and Children’s Central Hospital. 2.Infertile women with a history of recurrent implantation failure. 3.Infertile couples (both male and female) aged between 20 and 39 years;4. Couples who have at least 1 good quality embryos for transfer. 5. Males had negative in infectious disease test. 6. The males have semen. 7. Women who intend to undergo FET after IVF or ICSI or pre-implantation genetic testing for aneuploidy (PGT-A). 8. Competent and able to give informed consent. Intervention and comparator: Treatment group receiving intrauterine administration of seminal plasma before frozen-thawed embryo transfer. Main outcomes: Clinical pregnancy after frozen-thawed embryo transfer. Randomisation: Patients will be randomly allocated to either treatment or control group at 1:1 ratio. Random numbers will be generated by using software SPSS 25.0 performed by an independent statistician from Chengdu Women’s and Children’s Central Hospital. Blinding (masking): Only the data analyst will be blinded to group assignment. Numbers to be randomised (sample size): To account for a 10% dropout rate, we will recruit 174 patients (87 in each group). Trial status: The date of approval is 31rd May 2021, version 2.0. Recruitment started on 1rd June and is expected to end in July 2022. Discussion: Intrauterine administration of seminal plasma before frozen-thawed embryo transfer of patients with recurrent implantation failure may improve clinical pregnancy rate, it has great Page 2 of 14 significance for assisted reproduction. Trial registration: The study protocol has been approved by the ethics committees at Chengdu Women’s and Children’s Central Hospital. The trial was registered at the Chinese Clinical Trial Registry ChiCTR2100046803. Registered on 28 May 2021.


Author(s):  
Abbas Aflatoonian ◽  
Banafsheh Mohammadi

Background: Luteal-phase support is a complex and controversial issue in the field of reproductive management. Objective: To compare the safety and efficacy of low-dose subcutaneous progesterone with the vaginal progesterone for luteal-phase support in patients undergoing rozenthawed embryo transfer. Materials and Methods: In this cross-sectional study, information related to 77 women that had frozen-thawed embryo transfer was reviewed. The patients were divided into two groups based on the route of progesterone administration used as a luteal-phase support. When the endometrial thickness reached ≥ 8 mm, in one group progesterone (Prolutex) 25 mg/ daily subcutaneous and in another group, vaginal progesterone (Cyclogest®) 400 mg twice or (Endometrin®) 100 mg thrice daily, were administrated and continued until menstruation or in case of clinical pregnancy for 8 wk after the embryo transfer when the fetal heart activity was detected by ultrasonography. Results: The patient’s characteristics were matched and there was no significant difference. The chemical and clinical pregnancy rate was higher in the vaginal progesterone group compared to the prolutex group, but statistically unnoticeable, (40% vs. 29.6%, p = 0.367) and (28% vs. 22.2%, p = 0.581), respectively. C Conclusion: The findings of this study demonstrate that the new subcutaneous progesterone can be a good alternative for intramuscular progesterone in women that dislike and do not accept vaginal formulations as luteal-phase support in assisted reproductive technology. Key words: Progesterone, Subcutaneous, Vaginal, Pregnancy.


2020 ◽  
Author(s):  
Yuan Liu ◽  
Yixia Yang ◽  
Xinting Zhou ◽  
Yanmei Hu ◽  
Yu Wu

Abstract Background: Previous studies have demonstrated that newborns from fresh embryo transfer are with higher risk of small for gestation (SGA) rate than those from frozen-thawed embryo transfer (FET). It is suggested that supraphysiologic serum estradiol in controlled ovarian stimulation (COS)is one of reasons. Out study aims to investigate whether exogenous estradiol delivered regimens have an impact on live birth rate and singleton birthweight in hormone replacement (HRT)-FET cycles.Methods:This retrospective study involved patients undergoing their first FET with HRT endometrium preparation followed by two cleavage-staged embryos transfer, comparing orally and vaginal estradiol tablets (OVE) group versus oral estradiol tablets (OE) group from January 2015 to December 2018 at our center. A total of 792 patients fulfilled the criteria, including 282 live birth singletons. Live birth was the primary outcome. Secondary outcome included clinical pregnancy rate, singleton birthweight, large for gestational age (LGA) rate, SGA rate, preterm delivery rate. Results:Patients in OVE group achieved higher serum estradiol level with more days of estradiol treatment. No difference in live birth (Adjusted OR 1.327; 95%CI 0.982, 1.794, p=0.066) and clinical pregnancy rate (Adjusted OR 1.278; 95%CI 0.937, 1.743, p=0.121) was found between OVE and OE groups. Estradiol route did not affect birth weight (β=-30.962, SE=68.723, p=0.653), the odds of LGA (Adjusted OR 1.165; 95%CI 0.545, 2.490, p=0.694), the odds of SGA (Adjusted OR 0.569; 95%CI 0.096, 3.369, p=0.535) or the preterm delivery rate (Adjusted OR 0.969; 95%CI 0.292, 3.214, p=0.959).Conclusion:Estrogen orally and vaginally together did not have an impact on clinical outcomes and singleton birthweight compared to estrogen orally taken, but was accompanied with relative higher serum E2 level and potential maternal undesirable risks.


2021 ◽  
Author(s):  
Ping Zhou ◽  
QiuPing Yao ◽  
Lihua Yang ◽  
Ya Yu ◽  
Jilai Xie ◽  
...  

Abstract Objective Thyroid autoimmunity (TAI) per se has been demonstrated to be related to adverse pregnancy outcomes, including recurrent miscarriage and unexplained infertility. Although therapy of glucocorticoid to infertile remains controversial, aspirin combined with prednisone(P + A) are used frequently in antithyroid antibodies (ATA) positive infertile women in clinical practice. Methods A multicenter retrospective study was performed in the Second Affiliated Hospital of Zhejiang University School of Medicine, Ningbo Women and Children's Hospital and People's Hospital of Jinhua. We recruited 494 euthyroid infertile women positive for anti-thyroperoxidase antibody (TPOAb) and/or thyroglobulin antibody (TgAb) with thyroid stimulating hormone 0.35-4.0mIU/L, who undergoing first in vitro fertilization and embryo transfer (IVF-ET) cycle during the period of 2017 to 2020. 346 women were ultimately recruited, including 187 patients receiving fresh embryo transfer and 159 patients receiving frozen-thawed embryo transfer. Among them, infertile 150 women were treated with prednisone(10mg/d) and aspirin(100mg/d), while the other 196 infertile women were untreated as control group. The treatment commenced on the day of embryo transfer and continued until the clinical pregnancy was determined by ultrasonography around 30 days after embryo transfer. Results Clinical pregnancy rate (CPR) of the first fresh embryo transfer cycle was 57.5% vs. 63.5% in control vs. in treated group (P = 0.414) and CPR was 57.8% versus 61.8% in the two groups in the frozen-thawed embryo transfer cycle(P = 0.606). Additionally, the prevalence of delivering a live birth at the fresh embryo transfer was 49.6% in the non-treatment group and 47.3% in the P + A treated group(P = 0.762). Cumulative CPR was similar in the groups at the fresh embryo transfer (control vs treated group: 56.9% vs 61.0%, P = 0.534). By conducting logistic regression, combined treatment of P + A appeared to have no influence on CPR or miscarriage rates (MR) at the first embryo transfer. Furthermore, the low but within the reference level of free triiodothyronine (FT3) was seen as a poor predictor of spontaneous abortion at the fresh embryo transfer. Conclusions To conclude, with regard to euthyroid women with TAI undergoing the first IVF-ET cycle, adjuvant treatment of P + A after the embryo transfer may be unnecessary irrespective of the fresh or frozen-thawed embryo transfer.


Sign in / Sign up

Export Citation Format

Share Document