scholarly journals Effect of Flexible Half-dose Gonadotropin-releasing Hormone Antagonist Protocol on in Vitro Fertilization Outcome in Predicted Normal Responder: A Study Protocol for a Multicentered, Randomized, Non-inferiority, Parallel Controlled Trial

2021 ◽  
Author(s):  
Ying-Jie Ma ◽  
Jing-Yan Song ◽  
Meng-Yao Li ◽  
Zhengao Sun
Keyword(s):  
Controlled Trial ◽  
Embryo Implantation ◽  
Reproductive Outcomes ◽  
Ongoing Pregnancy ◽  
Releasing Hormone ◽  
Randomized Controlled ◽  
Conventional Dose ◽  
Half Dose ◽  
Ivf Et

Abstract BackgroundGonadotropin-releasing hormone antagonists (GnRH-ant) are widely used in current in vitro fertilization-embryo transfer (IVF-ET), however, whether the lowest daily dose of GnRH-ant is individualized remains unknown. Due to the negative effect of GnRH-ant on endometrial receptivity, lessening the amount of GnRH-antagonists used during controlled ovarian stimulation may be helpful for embryo implantation. As such, a randomized controlled study is essential to validate the feasibility and efficacy of daily GnRH-ant dose reduction to 0.125 mg geared towards providing scientific evidence for guidance in clinical practice.MethodsIn total, 620 infertile women undergoing in vitro fertilization will be enrolled in the multicentered, randomized, parallel controlled trial. Based on a computer-generated random list, they will be randomly and equally subdivided into half-dose GnRH-ant group or conventional-dose GnRH-ant group. The primary outcome is ongoing pregnancy i.e., intrauterine pregnancy diagnosed by pelvic ultrasonography at more than 12 weeks of gestation accompanied by normal fetal heartbeats. Secondary outcomes include cycle cancellation, premature luteinizing hormone surge, positive pregnancy, embryo implantation rate, clinical pregnancy, early spontaneous abortion, and live birth. The intention-to-treat and per protocol analyses will be used to initially analyze the difference in ongoing pregnancy rate between the two groups, while the multiple imputation method was used to handle missing values in the data.DiscussionAt present, no randomized controlled trials (RCTs) have been performed on the use of the half-dose GnRH-ant protocol (0.125mg/d) to improve reproductive outcomes of IVF-ET in predicted normal responder, compared to conventional-dose GnRH-ant protocol (0.25mg/d). Half-dose GnRH-ant protocol might provide a suitable clinical solution for predicted normal responder undergoing IVF treatment. Thus, it is critical to conduct a well-designed RCT to evaluate the impact of a half-dose GnRH-ant protocol on the reproductive outcomes of IVF-ET in predicted normal responder.Trial registrationThis study was registered in the Chinese Clinical Trials Registry Platform on August 29, 2020. (chictr.org.cn; identifier: ChiCTR2000037629).

scholarly journals 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: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Jing-Yan Song ◽  
Dan-Dan Gao ◽  
Xian-Ling Cao ◽  
Shan Xiang ◽  
Yan-Hua Chen ◽  
...  
Keyword(s):  
Embryo Transfer ◽  
Controlled Trial ◽  
Public Hospitals ◽  
Ongoing Pregnancy ◽  
Double Blind ◽  
Ongoing Pregnancy Rate ◽  
Double Blind Placebo ◽  
Group 4 ◽  
Ivf Et

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.

Fixed versus flexible gonadotropin-releasing hormone antagonist administration in in vitro fertilization: a randomized controlled trial

2011 ◽  
Vol 95 (2) ◽  
pp. 558-562 ◽  
Author(s):  
Efstratios M. Kolibianakis ◽  
Christos A. Venetis ◽  
Lydia Kalogeropoulou ◽  
Evangelos Papanikolaou ◽  
Basil C. Tarlatzis
Keyword(s):  
Randomized Controlled Trial ◽  
In Vitro Fertilization ◽  
Controlled Trial ◽  
Gonadotropin Releasing Hormone ◽  
Vitro Fertilization ◽  
Releasing Hormone ◽  
Randomized Controlled

scholarly journals Effectiveness of Herb-partitioned Moxibustion on the Navel for Pregnancy Outcomes in Patients With Recurrent Implantation Failure Undergoing in Vitro Fertilization and Embryo Transfer: A Study Protocol for a Randomized Controlled Trial

2021 ◽  
Author(s):  
Qingchang Xia ◽  
Shuzhong Gao ◽  
Jingyan Song ◽  
Dongqing Du ◽  
Chunjing Li ◽  
...  
Keyword(s):  
Pregnancy Rate ◽  
Embryo Transfer ◽  
Controlled Trial ◽  
Control Group ◽  
Implantation Failure ◽  
Vitro Fertilization ◽  
Menstrual Cycles ◽  
Randomized Controlled ◽  
Ivf Et

Abstract BackgroundRecurrent implantation failure (RIF) in the majority of patients undergoing in vitro fertilization and embryo transfer (IVF-ET) is caused by various factors such as maternal age, embryo quality, endometrial receptivity (ER) and immunity. The incidence of RIF is usually between 5and 10%. Previous studies have shown that herb-partitioned moxibustion on the navel is one of the treatment methods of acupuncture with a positive effect on pregnancy. However, its application in the treatment of RIF has not been reported. Therefore, this study aimed to explore the effectiveness of herb-partitioned moxibustion on the navel in improving the outcome of frozen embryo transfer (FET) in patients with RIF. MethodsThis study conducted a randomized controlled trial (RCT). It is planned to recruit 210 patients undergoing RIF for FET from Affiliated Hospital of Shandong University of Traditional Chinese Medicine and randomly divide them into the treatment group and the control group in a ratio of 1:1. The patient of the treatment group will be treated with herb-partitioned moxibustion on the navel once a week for three consecutive menstrual cycles. During the fourth menstrual cycle, will be induced to prepare the endometrium before embryo transfer. No intervention will be used in the control group for 3 menstrual cycles. However, in the fourth menstrual cycle, an artificial cycle will be induced to prepare the endometrium before embryo transfer. The conception outcome will be recorded after a 3-months follow-up. Primary outcome will be assessed as the ongoing pregnancy rate compared with the control group. Secondary outcomes include the endometrial type, resistance index (RI), pulsatility index (PI) of the bilateral uterine artery, endometrial blood flow, serum estradiol (E2), progesterone (P), biochemical pregnancy rate, implantation rate and clinical pregnancy rate. DiscussionIf the results confirm that the herb-partitioned moxibustion on the navel can improve IVF-ET outcomes in patients with RIF, it will be recommended for application in clinical practice.Trial registration:Chinese clinical trial registry (ChiCTR). Trial registration number: ChiCTR2100043954. Registered on 8 July 2021.

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