scholarly journals Comparison of the effect of immediate versus delayed transfer following a stimulated IVF cycle on the ongoing pregnancy rate of frozen-thawed embryo transfer cycles: a study protocol for a randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (5) ◽  
pp. e020507 ◽  
Author(s):  
He Li ◽  
Lu Li ◽  
Xiang Lu ◽  
Xiaoxi Sun ◽  
Ernest Hung Yu Ng
2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
P K Sim ◽  
P Nadkarni

Abstract Study question Between spontaneous ovulation (SPO) and induced ovulation (INO) comparing clinical pregnancy rate and ongoing pregnancy rate for frozen-thawed embryo transfer (FET) cycle, which is better? Summary answer Both spontaneous ovulation and induced ovulation protocols showed no significant difference in clinical pregnancy rates and ongoing pregnancy rates. What is known already Recent practice worldwide is moving towards elective freezing of all embryos and subsequent frozen-thawed transfer, both for a perceived higher pregnancy rate as well as the significant reduction of ovarian hyperstimulation. The timing of FET can be determined by either detecting the spontaneous Luteinizing Hormone surge (SPO group) or by the administration of hCG (INO group). There is still an ongoing debate to determine which is the best protocol for frozen-thawed embryo transfer in the non-hormone replacement therapy (non-HRT) cycle. Study design, size, duration This retrospective study included 500 FET cycles for patients who had regular menses between June 2017 and June 2020. The FET cycles were grouped by type as follows: SPO (n = 281) and INO (n = 219). The primary outcome was the clinical pregnancy rate and the secondary outcome was ongoing pregnancy rate. Ongoing pregnancy is defined as a viable intrauterine pregnancy at 12 weeks of gestation confirmed on an ultrasound scan. Participants/materials, setting, methods This study was conducted in a single IVF centre. Vitrification was used as the cryopreservation method. To standardize outcome measures, only patients having single blastocyst transfer and aged under 38 years old were included. The average age of the patient was 32.9. Gamete donation, embryo donation, pre-implantation testing and assisted hatching cycles were also excluded from the analysis. Categorical data were analysed using Chi-square test SPSS version 25. Main results and the role of chance Clinical pregnancy rate for SPO group was 54.8% (154/281) versus 52.9% (116/219) in INO group. Even though clinical pregnancy rate was higher in SPO group as compared to INO group, it did not reach significance level (ꭓ2 = 0.17, p = 0.68). As all patients had single blastocyst transferred, the implantation rate was the same as clinical pregnancy rate. Ongoing pregnancy rate was also found higher in SPO group as compared to INO group (135/281, 48.0% and 97/219, 44.3% respectively) but again failed to reach significance level (ꭓ2 = 0.70, p = 0.40). Limitations, reasons for caution The retrospective nature of the study and therefore, the analysis was not adjusted for confounding factors such as blastocyst grading, etiology of infertility, and ethnicity of patients. Wider implications of the findings: In natural cycle, both spontaneous ovulation and induced ovulation protocols had the same pregnancy outcomes for frozen-thawed embryo transfer. However, induced ovulation can facilitate in scheduling FET timing to avoid weekends and public holidays, if necessary. Trial registration number Not applicable


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.


2021 ◽  
Vol 12 ◽  
Author(s):  
Zhuo Liu ◽  
Fengyi Dong ◽  
Yunhan Wang ◽  
Mingming Zheng ◽  
Mengyang Song ◽  
...  

IntroductionIn clinical practice, the ideal time at which to perform a Frozen–thawed Embryo Transfer (FET) after a failed In-vitro Fertilization-embryo Transfer (IVF-ET) is still unclear to most practicing physicians. In addition, physicians often delay the introduction of FET due to concerns on the possible residual effects of ovarian hyperstimulation, which may interfere with the regular menstrual cycle. Moreover, given that most of the published studies on the topic are retrospective with contradictory findings, it is crucial to provide evidence-based randomized control guides for clinical practice.Methods/analysisThe study is a randomized, non-inferiority, parallel-group, controlled trial that will enroll a total of 732 women undergoing their first FET after a failed fresh embryo transfer (ET) cycle. The participants will then be randomized into two groups based on a computer-generated randomized list. The two groups include: (i) an immediate group were FET will be carried out during the first menstrual cycle after a failed fresh ET cycle and (ii) a delayed group where FET will be carried out during the second menstrual cycle after a failed fresh ET cycle. Primary outcomes will be defined as viable pregnancies with fetal heartbeats, diagnosed through pelvic ultrasonography after twelve weeks of gestation.Ethics and disseminationThe study was approved by the Ethics Committee of the Assisted Reproductive Medicine at the Affiliated Hospital of Shandong University of Traditional Chinese Medicine (SDTCM/E-2020.2.01). In addition, written informed consent will be obtained from all the participants before the study. The results of this trial will be disseminated in a peer-reviewed journal.DiscussionCurrently, there is no consensus with regard to the duration after which the effects of ovarian stimulation are observed after a failed fresh ET and the optimal time required to begin FET. Moreover, no randomized controlled trial exists that compares the ongoing pregnancy rates after immediate versus delayed FET following a failed fresh ET cycle. Therefore, it is important to conduct a well-designed randomized trial to determine whether it is necessary to delay FET for at least one menstrual cycle after the failure of fresh ET.Clinical Trial RegistrationChiCTR2000033313 (http://www.chictr.org.cn/enIndex.aspx).


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