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Article ; Online: The optimal timing of frozen-thawed embryo transfer

Yu-Qi Gao / Jing-Yan Song / Zhen-Gao Sun

Frontiers in Medicine, Vol

delayed or not delayed? A systematic review and meta-analysis

2024 Volume 10

Abstract: BackgroundThe use of frozen embryo transfer (FET) has grown exponentially over the past few years. However, in clinical practice, there are no specific criteria as to whether a delay of at least one menstrual cycle is required for an FET after a failed ... ...

Abstract	BackgroundThe use of frozen embryo transfer (FET) has grown exponentially over the past few years. However, in clinical practice, there are no specific criteria as to whether a delay of at least one menstrual cycle is required for an FET after a failed fresh ET or a freeze-all cycle.ObjectiveThrough the effects on live birth rate (LBR), clinical pregnancy rate (CPR) and pregnancy loss rate (PLR), to determine whether FET requires a delay of at least one menstrual cycle after fresh ET failure or a freeze-all cycle.MethodsThe search was conducted through PubMed, Web of Science, CNKI, and Wanfang databases for terms related to FET timing as of April 2023. There are no restrictions on the year of publication or follow-up time. Women aged 20 to 46 with any indication for in vitro fertilization and embryo transfer (IVF-ET) treatment are eligible for inclusion. Oocyte donation studies are excluded. Except for the case report, study protocol, and abstract, all original studies are included.ResultsIn 4,124 search results, 19 studies were included in the review. The meta-analysis includes studies on the adjusted odds ratio (OR) and 95% confidence interval (CI) of reported live birth rate (LBR), clinical pregnancy rate (CPR), and pregnancy loss rate (PLR), 17 studies were retrospective cohort study, and 2 studies were randomized controlled trial, a total of 6,917 immediate FET cycles and 16,105 delayed FET cycles were involved. In this meta-analysis, the combined OR of LBR was [OR = 1.09, 95% CI (0.93–1.28)], the combined OR of CPR was [OR = 1.05, 95% CI (0.92–1.20)], and the combined OR of PLR was (OR = 0.96, 95% CI 0.75–1.22). There was no statistical significance between the two groups.ConclusionOverall, delaying FET by at least one menstrual cycle has no advantage in LBR, CPR, or PLR. So, flexible scheduling of FETs is available to both doctors and patients.Systematic review registrationhttps://www.crd.york.ac.uk/PROSPERO/, identifier CRD42020161648.
Keywords	in vitro fertilization ; frozen-thawed embryo transfer ; immediate ; delayed ; live birth ; Medicine (General) ; R5-920
Subject code	610
Language	English
Publishing date	2024-01-01T00:00:00Z
Publisher	Frontiers Media S.A.
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Premature timing of progesterone luteal phase support initiation did not negatively impact live birth rates in modified natural frozen thawed embryo transfer cycles

Wen-Jing Jiang / Zhen-Gao Sun / Jing-Yan Song

Heliyon, Vol 9, Iss 2, Pp e13218- (2023)

2023

Abstract: Study question: In a modified natural cycle frozen-thawed embryo transfer (mNC-FET), does the premature timing of progesterone luteal phase support (LPS) initiation 24 h following human chorionic gonadotropin (hCG) trigger impact live birth? Summary ... ...

Abstract	Study question: In a modified natural cycle frozen-thawed embryo transfer (mNC-FET), does the premature timing of progesterone luteal phase support (LPS) initiation 24 h following human chorionic gonadotropin (hCG) trigger impact live birth? Summary answer: Premature LPS initiation did not negatively affect the live birth rate (LBR) in mNC-FET cycles compared with conventional LPS initiation 48 h after hCG triggering. What is known already: During natural cycle FET, human chorionic gonadotropin is routinely used to mimic endogenous luteinizing hormone (LH) surge to induce ovulation, which allows more flexibility in embryo transfer scheduling, thus relieving the burden of multiple visits by patients and laboratory workloads, which is also known as mNC-FET. Moreover, recent data demonstrates that ovulatory women undergoing natural cycle FETs have a lower risk of maternal and fetal complications due to the essential role of the corpus luteum in implantation, placentation and pregnancy maintenance. While several studies have confirmed the positive effects of LPS in mNC-FETs, the timing of progesterone LPS initiation is still unclear, as compared with fresh cycles where robust research has been conducted. To the best of our knowledge, no clinical studies comparing different beginning days in mNC-FET cycles have been published. Study design, size, duration: This retrospective cohort study involved 756 mNC-FET cycles performed at a university-affiliated reproductive center between January 2019 and August 2021. The primary outcome measured was the LBR. Participants/materials, setting, methods: Ovulatory women ≤42 years of age who were referred for their autologous mNC-FET cycles were included in the study. According to the timing of progesterone LPS initiation following the hCG trigger, patients were assigned into two categories: premature LPS group (progesterone initiation 24 h after hCG trigger, n = 182) versus conventional LPS group (progesterone initiation 48 h after hCG trigger, n = 574). Multivariate logistic ...
Keywords	Modified natural cycle/frozen-thawed embryo transfer/human chorionic gonadotropin /luteinizing hormone/in vitro fertilization and embryo transfer ; Science (General) ; Q1-390 ; Social sciences (General) ; H1-99
Subject code	630
Language	English
Publishing date	2023-02-01T00:00:00Z
Publisher	Elsevier
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Impact of progesterone-free luteal phase support following natural cycle frozen embryo transfer

Wen-Jing Jiang / Zhen-Gao Sun / Jing-Yan Song

Frontiers in Medicine, Vol

Study protocol for a multicenter, non-inferiority, randomized controlled trial

2022 Volume 9

Abstract: IntroductionNowadays, frozen-thawed embryo transfer (FET) has become one of the standard treatments for infertility in the field of assisted reproductive technology (ART). Natural cycle FET (NC-FET) has many advantages, such as simplicity and economics, ... ...

Abstract	IntroductionNowadays, frozen-thawed embryo transfer (FET) has become one of the standard treatments for infertility in the field of assisted reproductive technology (ART). Natural cycle FET (NC-FET) has many advantages, such as simplicity and economics, no effect on patients’ menstrual cycles, estrogen and progesterone levels, as well as no interference in endometrial growth and transformation, which is aligned with the natural physiological state of embryo implantation. Nonetheless, there is a controversy regarding the need for luteal phase support (LPS) during NC-FET cycles. The purpose of this study is to assess whether LPS was not inferior to non-LPS in terms of OPR in NC-FET cycles.Methods and analysisThis study including 1,010 ovulatory women undergoing in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) cycles with an elective freeze-all strategy followed by NC-FET will be performed at four university-affiliated reproductive centers. Participants will be randomly assigned in a 1:1 ratio to receive LPS treatment or not. This study is designed as an open-label, non-inferiority, randomized controlled trial (RCT), and the primary statistical strategies were intention-to-treat (ITT) and per-protocol (PP) analysis.DiscussionThere may not have been any significant difference in the chance of a live birth after FET if no progesterone was supplemental during the luteal phase. However, due to the limited number of previous studies, which are mainly retrospective, evidence is still limited. Thus, by conducting this multicenter RCT, we intend to evaluate whether LPS is necessary in NC-FET.Ethics and disseminationA Reproductive Ethics Committee of the Affiliated Hospital of Shandong University of Traditional Chinese Medicine (SDUTCM) has approved this study. This study will handle the data as required by general data protection regulations. Participants will sign a written informed consent regarding participation in the study and storage of blood samples in a biobank for future research. This study ...
Keywords	luteal phase support (LPS) ; natural cycle ; frozen embryo transfer (FET) ; spontaneous ovulation ; assisted reproductive technology (ART) ; Medicine (General) ; R5-920
Subject code	630
Language	English
Publishing date	2022-11-01T00:00:00Z
Publisher	Frontiers Media S.A.
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Erzhi Tiangui Granules Improve In Vitro Fertilization Outcomes in Infertile Women with Advanced Age

Jinlong Sun / Jing-Yan Song / Yao Dong / Shan Xiang / Qiong Guo

Evidence-Based Complementary and Alternative Medicine, Vol

2021 Volume 2021

Abstract: Background. The fertility of females with advanced age declines with aging. Therefore, for medical and social reasons, it is important to establish mechanisms to protect and improve the fertility of such populations. With widespread use of traditional ... ...

Abstract	Background. The fertility of females with advanced age declines with aging. Therefore, for medical and social reasons, it is important to establish mechanisms to protect and improve the fertility of such populations. With widespread use of traditional Chinese medicine (TCM) in in vitro fertilization (IVF), studies have evaluated their impact on improving the fertility of females with advanced age. In this study, we performed proteomic analysis of follicular fluid to reveal mechanisms of the Erzhi Tiangui (EZTG) granule (Chinese herbs for replenishing vital essence to tonify the kidney) in improving the outcomes of IVF in infertile women with advanced age. Methods. This was a randomized, double-blind, and placebo-controlled trial in which 100 patients with advanced age were divided into the EZTG group and the placebo group by the random number table plus envelope method. Both groups were subjected to controlled ovarian stimulation with a GnRH antagonist regimen. Differences between the two groups were evaluated, including the TCM syndrome score after treatment, gonadotrophin (Gn) days and Gn doses, the number of retrieved oocytes, 2 pronucleus (PN) fertilization, 2PN cleavage, and high-quality embryos. Differentially expressed proteins were identified using the LC-MS/MS method, and their functions were determined through bioinformatics analyses. Results. The number of high-quality embryos in the placebo group was significantly lower than that in the EZTG group (2.88 ± 1.85 vs. 4.13 ± 2.83, p=0.011). Eleven differentially expressed proteins were identified between the two groups. Four proteins were highly expressed, whereas seven were suppressed in the control group, compared to the EZTG group. The overall trend suggested that the apoptotic effect in the follicular fluid of the EZTG group was downregulated. Conclusion. Treatment with the EZTG granule can improve embryo quality in IVF of advanced age females with both kidney Qi and Yin deficiency syndromes. The mechanism is attributed to downregulation of ...
Keywords	Other systems of medicine ; RZ201-999
Subject code	610
Language	English
Publishing date	2021-01-01T00:00:00Z
Publisher	Hindawi Limited
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Is Human Chorionic Gonadotropin Trigger Beneficial for Natural Cycle Frozen-Thawed Embryo Transfer?

Dan-Dan Gao / Li Li / Yi Zhang / Xiao-Xuan Wang / Jing-Yan Song / Zhen-Gao Sun

Frontiers in Medicine, Vol

2021 Volume 8

Abstract: Objective: The aim of this study is to investigate, in ovulatory patients, whether there is a difference in reproductive outcomes following frozen-thawed embryo transfer (FET) in natural cycles (NC) compared to modified natural cycles (mNC).Methods: This ...

Abstract	Objective: The aim of this study is to investigate, in ovulatory patients, whether there is a difference in reproductive outcomes following frozen-thawed embryo transfer (FET) in natural cycles (NC) compared to modified natural cycles (mNC).Methods: This retrospective cohort study, performed at the public tertiary fertility clinic, involved all infertile patients undergoing endometrial preparation prior to FET in NC and mNC from January, 2017 to November, 2020. One thousand hundred and sixty-two patients were divided into two groups: mNC group (n = 248) had FET in a NC after ovulation triggering with human chorionic gonadotropin (hCG); NC group (n = 914) had FET in a NC after spontaneous ovulation were observed. The primary outcome was live birth rate. All pregnancy outcomes were analyzed by propensity score matching (PSM) and multivariable logistic regression analyses.Results: The NC group showed a higher live birth rate [344/914 (37.6%) vs. 68/248 (27.4%), P = 0.003; 87/240 (36.3%) vs. 66/240 (27.5%), P = 0.040] than the mNC group before and after PSM analysis. Multivariable analysis also showed mNC to be associated with a decreased likelihood of live birth compared with NC [odds ratio (OR) 95% confidence interval (CI) 0.71 (0.51–0.98), P = 0.039].Conclusion: For women with regular menstrual cycles, NC-FET may have a higher chance of live birth than that in the mNC-FET cycles. As a consequence, it's critical to avoid hCG triggering as much as possible when FETs utilize a natural cycle strategy for endometrial preparation. Nevertheless, further more well-designed randomized clinical trials are still needed to determine this finding.
Keywords	human chorionic gonadotropin ; modified natural cycle ; natural cycle ; propensity score matching ; frozen-thawed embryo transfer (FET) ; Medicine (General) ; R5-920
Subject code	610
Language	English
Publishing date	2021-10-01T00:00:00Z
Publisher	Frontiers Media S.A.
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Study protocol

Ying-jie Ma / Xian-ling Cao / Ting Ma / Jing-yan Song / Ling-yu Yu / Yang-yang Yu / Jian-Yun Zhao / Zhen-Gao Sun

Trials, Vol 22, Iss 1, Pp 1-

a multi-center, double-blind, randomized, 6-month, placebo-controlled trial to investigate the effect of supplementing hormone therapy FET cycles with Gushen’antai pills on the outcomes of in vitro fertilization

2021 Volume 11

Abstract: Abstract Background Infertility is a widespread global challenge. Currently, the most effective treatment strategy for infertility is in vitro fertilization (IVF), which is an assisted reproductive technique (ART). The use of IVF for assisted pregnancy ... ...

Abstract	Abstract Background Infertility is a widespread global challenge. Currently, the most effective treatment strategy for infertility is in vitro fertilization (IVF), which is an assisted reproductive technique (ART). The use of IVF for assisted pregnancy dates back to the last 41 years when the first IVF baby was born. During IVF, many oocytes are obtained in an IVF cycle, and more than one embryo is formed. Subsequently, frozen-thawed embryo transfer (FET) is increasingly being used in IVF cycles for women in whom a fresh embryo transfer fails to result in a pregnancy, or in those who return for a second baby. However, the pregnancy success rates following FET treatment cycles are reportedly lower than in fresh embryo transfers. Therefore, recent related studies are increasing determining mechanisms of improving the sustained pregnancy rate of FET and reducing the rate of early abortion. The Gushen’antai pill (GSATP), which contains a mixture of 10 herbs, has been widely used in traditional Chinese medicine (TCM) as a pharmacological option to prevent miscarriage. However, randomized controlled trials (RCT) have never been conducted to provide high-level clinical evidence on the clinical efficacy of GSATP. The objective of this study is to investigate the effect of GSATP of hormone therapy (HT) FET cycles on pregnancy rate. Methods A total of 300 subjects aged between 18 and 40 years which prepared for HT cycle FET will be enrolled in the study. The patients were from five different hospitals, with 60 patients from each hospital. Patients were randomly divided into two groups, and medication was started on the day of endometrial transformation. After FET 28 days, B-ultrasound was done to determine whether to continue the medication. Baseline assessments were carried out before the trial and outcomes were collected 4, 6, 8, 10, and 12 weeks of each gestational cycle. Discussion Differences in ongoing pregnancy rate, clinical pregnancy rate, implantation rate, and threatened abortion rate between the two groups will be statistically analyzed. We can finally have an objective evaluation of the efficacy of the traditional Chinese medicine Gushen’antai pills. Trial registration ChiCTR1900026737 . Registered October 20, 2019.
Keywords	FET ; Hormone therapy ; TCM ; Randomized controlled trial ; Ongoing pregnancy rate ; Medicine (General) ; R5-920
Subject code	150
Language	English
Publishing date	2021-09-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: The Mechanism of Traditional Chinese Medicine Based on Semi-Targeted Metabolomics to Improve IVF Outcomes in Senile Patients

Ying-Jie Ma / Li-Hua Yuan / Ji-Mei Xiao / Hua-Ying Jiang / Yuan-Hong Sa / Hong-Qi Sun / Jing-Yan Song / Zhen-Gao Sun

Evidence-Based Complementary and Alternative Medicine, Vol

2021 Volume 2021

Abstract: Objective. To identify the biological function and metabolic pathway of differential metabolites in follicular fluid of senile patients with kidney qi deficiency undergoing in vitro fertilization-embryo transfer (IVF-ET) and observe the effect of kidney- ... ...

Abstract	Objective. To identify the biological function and metabolic pathway of differential metabolites in follicular fluid of senile patients with kidney qi deficiency undergoing in vitro fertilization-embryo transfer (IVF-ET) and observe the effect of kidney-invigorating herbs on IVF outcomes in senile patients. Methods. A total of 95 women undergoing IVF treatment were recruited and divided into three groups, including 34 cases in the treatment group (the senile patients with kidney qi deficiency after the intervention of Chinese medicine), 31 cases in the experiment group (the senile patients with kidney qi deficiency of no intervention of Chinese medicine), and 30 cases in the control group (young women with infertility due to male factor). The three groups of women were treated with long protocol ovarian hyperstimulation; the treatment group was given Qi-Zi-Yu-Si decoction on the day of HCG downregulation. Their IVF clinical outcomes were observed. The metabolites changes of kidney qi deficiency syndrome were analyzed in follicular fluid metabolomics using liquid chromatography-mass spectrometry (UPLC-MS/MS). Results. The syndrome score of kidney qi deficiency syndrome in the treatment group was significantly improved after treatment (P<0.01). Compared with the experiment group, the available embryo rate and implantation rate were increased, and the difference was statistically significant (P<0.05). Progesterone, indoleacrylic acid, 2-propenyl 1-(1-propenylsulfinyl) propyl disulfide, N-acetyltryptophan, decanoylcarnitine, 20a-dihydroprogesterone, testosterone acetate, eicosatrienoic acid, 1H-indole-3-carboxaldehyde, choline, phosphorylcholine, and tryptophan were downregulated in the treatment group. Through pathway analysis, glycerophospholipid metabolism and steroid hormone biosynthesis were regulated in senile patients with kidney qi deficiency after Qi-Zi-Yu-Si decoction intervention. Conclusion. Qi-Zi-Yu-Si decoction can effectively improve the IVF outcome and clinical symptoms of senile patients. ...
Keywords	Other systems of medicine ; RZ201-999
Subject code	616
Language	English
Publishing date	2021-01-01T00:00:00Z
Publisher	Hindawi Limited
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Effect of duration of gonadotropin releasing hormone agonist on the outcome of in vitro fertilization-embryo transfer in a short-acting long regimen

Zhen-Ni MU / Zhen-Gao Sun / Jing-Yan Song / Hong-Gen Liu / Yan Qiao / Qing-Chang Xia

Libyan Journal of Medicine, Vol 14, Iss

2019 Volume 1

Abstract: Objective: To investigate the effect of the duration of gonadotropin releasing hormone agonist (GnRH-a) use on the outcome of in vitro fertilization and embryo transfer (IVF-ET) during the short-acting long-term hyperstimulation cycle. Methodology: ... ...

Abstract	Objective: To investigate the effect of the duration of gonadotropin releasing hormone agonist (GnRH-a) use on the outcome of in vitro fertilization and embryo transfer (IVF-ET) during the short-acting long-term hyperstimulation cycle. Methodology: Clinical data from 776 patients receiving controlled ovarian stimulation (COS) after short-term regimen downregulation were retrospectively analyzed. According to the duration of GnRH-a, the patients were divided into 3 groups: Group A, 14 days for GnRH-a; Group B, 15–17 days for GnRH-a; and Group C, >18 days for GnRH-a. The clinical data, treatment and clinical outcomes were compared among the groups. Results: There were no significant differences in fertilization rate, implantation rate, clinical pregnancy rate, abortion rate, ovarian hyperstimulation syndrome (OHSS) rate(P > 0.05). The total costs in group A were significantly less than those in group B and C(P < 0.001). The number of eggs and quality embryos generated in group A was significantly higher than that in groups B and C (P = 0.014, P = 0.005). Conclusions: In the short-acting GnRH agonist long protocol, satisfactory IVF-ET pregnancy outcome was obtained with the use of GnRH-a for 14 days under the premise of lowering the receptor-regulating standard. Excessive application of GnRH-a will affect the number of eggs and embryos and increase the cost of medical treatment.
Keywords	short-acting long protocol ; pituitary down-regulation ; gnrh-a ; clinical pregnancy rate ; in vitro fertilization ; Medicine ; R
Subject code	610 ; 630
Language	English
Publishing date	2019-01-01T00:00:00Z
Publisher	Taylor & Francis Group
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: A Multi-Task Group Bi-LSTM Networks Application on Electrocardiogram Classification

Qiu-Jie Lv / Hsin-Yi Chen / Wei-Bin Zhong / Ying-Ying Wang / Jing-Yan Song / Sai-Di Guo / Lian-Xin Qi / Calvin Yu-Chian Chen

IEEE Journal of Translational Engineering in Health and Medicine, Vol 8, Pp 1-

2020 Volume 11

Abstract: Background: Cardiovascular diseases (CVD) are the leading cause of death globally. Electrocardiogram (ECG) analysis can provide thoroughly assessment for different CVDs efficiently. We propose a multi-task group bidirectional long short-term memory ( ... ...

Abstract	Background: Cardiovascular diseases (CVD) are the leading cause of death globally. Electrocardiogram (ECG) analysis can provide thoroughly assessment for different CVDs efficiently. We propose a multi-task group bidirectional long short-term memory (MTGBi-LSTM) framework to intelligent recognize multiple CVDs based on multi-lead ECG signals. Methods: This model employs a Group Bi-LSTM (GBi-LSTM) and Residual Group Convolutional Neural Network (Res-GCNN) to learn the dual feature representation of ECG space and time series. GBi-LSTM is divided into Global Bi-LSTM and Intra-Group Bi-LSTM, which can learn the features of each ECG lead and the relationship between leads. Then, through attention mechanism, the different lead information of ECG is integrated to make the model to possess the powerful feature discriminability. Through multi-task learning, the model can fully mine the association information between diseases and obtain more accurate diagnostic results. In addition, we propose a dynamic weighted loss function to better quantify the loss to overcome the imbalance between classes. Results: Based on more than 170,000 clinical 12-lead ECG analysis, the MTGBi-LSTM method achieved accuracy, precision, recall and F1 of 88.86%, 90.67%, 94.19% and 92.39%, respectively. The experimental results show that the proposed MTGBi-LSTM method can reliably realize ECG analysis and provide an effective tool for computer-aided diagnosis of CVD.
Keywords	ECG ; bidirectional long short-term memory network ; attention mechanism ; multi-task learning ; Computer applications to medicine. Medical informatics ; R858-859.7 ; Medical technology ; R855-855.5
Subject code	004 ; 006
Language	English
Publishing date	2020-01-01T00:00:00Z
Publisher	IEEE
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: The Role of Traditional Chinese Formula Ding-Kun Pill (DKP) in Expected Poor Ovarian Response Women (POSEIDON Group 4) Undergoing In Vitro Fertilization-Embryo Transfer

Jing-Yan Song / Dan-Dan Gao / Xian-Ling Cao / Shan Xiang / Yan-Hua Chen / Yi-Li Teng / Xiu-Fang Li / Hai-Ping Liu / Fu-Xin Wang / Bin Zhang / Li-Hua Xu / Li Zhou / Xiang-Hong Huang / Zhen-Gao Sun

Frontiers in Endocrinology, Vol

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

2021 Volume 12

Abstract: ObjectiveThe primary objective of the study was to assess traditional Chinese formula DKP supplementation in terms of efficacy and safety on reproductive outcomes of expected poor ovarian responder (POR, POSEIDON Group 4) undergoing in vitro ... ...

Abstract	ObjectiveThe primary objective of the study was to assess traditional Chinese formula DKP supplementation in terms of efficacy and safety on reproductive outcomes of expected poor ovarian responder (POR, POSEIDON Group 4) undergoing in vitro fertilization-embryo transfer (IVF-ET).Design, Setting, and ParticipantsWomen eligible for IVF-ET were invited to participate in this randomized, double-blind, placebo-controlled, superiority trial at academic fertility centers of ten public hospitals in Chinese Mainland. A total of 462 patients (35–44 years) equally divided between DKP and placebo groups with antral follicle count (AFC) <5 or anti-müllerian hormone (AMH) <1.2 ng/ml were randomized.InterventionsAll participants were given DKP or 7 g placebo twice daily on the previous menstrual cycle day 5 until oocyte retrieval, which took approximately 5 to 6 weeks.Main Outcome MeasureThe primary outcome was the ongoing pregnancy defined as more than 20 gestational weeks of an intrauterine living fetus confirmed by pelvic ultrasonography.ResultsDemographic characteristics were equally distributed between the study populations. Intention-to-treat (ITT) analysis revealed that ongoing pregnancy rate (OPR) was not significantly different between DKP and placebo groups [26.4% (61/231) versus 24.2% (56/231); relative risk (RR) 1.09, 95% confidence interval (CI) 0.80 to 1.49, P = 0.593]. No significant differences between groups were observed for the secondary outcomes. The additional per protocol (PP) analysis was in line with ITT results: OPR in DKP group was 27.2% (61/224) versus 24.1% (55/228) in placebo group [RR 1.13, 95%CI (0.82 to 1.55), P = 0.449]. After subgroup analysis the findings concluded that POR population of 35–37 years had a significantly higher OPR after 5–6 weeks of oral DKP (41.8%, 33/79) versus placebo (25.4%, 18/71) [RR 1.65, 95% CI (1.02 to 2.65), P = 0.034, P for interaction = 0.028].ConclusionThis well-designed randomized controlled trial (RCT) offers new high-quality evidence to supplement existing retrospective literature concerning DKP performance in expected PORs. DKP could be recommended as a safe and natural remedy for expected PORs (aged 35–37 years) who fulfill the POSEIDON group 4 criteria. However, additional interventional clinical studies are undoubtedly required to be conducted in the future to validate this hypothesis.Clinical Trial Registrationwww.chictr.org.cn, identifier ChiCTR1900026614.
Keywords	POSEIDON criteria ; low prognosis ; Ding-Kun Pill ; traditional Chinese medicine ; poor ovarian response ; in vitro fertilization-embryo transfer ; Diseases of the endocrine glands. Clinical endocrinology ; RC648-665
Subject code	610
Language	English
Publishing date	2021-06-01T00:00:00Z
Publisher	Frontiers Media S.A.
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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