Effects of the Zishen Yutai Pill Compared With Placebo on Live Births Among Women in a Fresh Embryo Transfer Cycle: A Randomized Controlled Trial.

OBJECTIVE: To assess the efficacy of the Zishen Yutai Pill compared with placebo on live birth rates among women after fresh embryo transfer cycles. METHODS: We conducted a double-blind, multicenter, placebo-controlled, randomized trial to investigate whether administration of the Zishen Yutai Pill would improve pregnancy outcomes among women undergoing fresh embryo transfer after in vitro fertilization or intracytoplasmic sperm injection. The primary outcome was live birth rate. Secondary outcomes were rates of implantation, biochemical pregnancy, clinical pregnancy, pregnancy loss, cycle cancellation, and maternal, fetal, and neonatal complications. A total sample size of 2,265 women (1:1 in two groups) was used to detect a live birth rate difference between the Zishen Yutai Pill and placebo. Participants were enrolled and randomized to receive 5 g of the Zishen Yutai Pill or placebo orally, three times per day during the study. RESULTS: Recruitment was completed between April 2014 and June 2017, with 2,580 patients screened. Two thousand two hundred sixty-five patients were randomized: 1,131 to the Zishen Yutai Pill and 1,134 to placebo. Characteristics were similar between groups. In intention-to-treat analysis, the rates of live birth in the Zishen Yutai Pill (ZYP) group and placebo group were 26.8% and 23.0% (rate ratio [RR], 1.16; 95% CI 1.01-1.34; P=.038), respectively. The implantation rates were 36.8% and 32.6% in the ZYP and placebo groups, respectively (RR 1.13; 95% CI 1.01-1.25; P=.027). The biochemical pregnancy rate for the ZYP group was 35.5% compared with 31.1% in the placebo group (RR 1.14; 95% CI 1.02-1.28; P=.026). The rates of clinical pregnancy in the ZYP and placebo groups were 31.2% compared with 27.3%, respectively (RR 1.14; 95% CI 1.00-1.30; P=.043). There were no significant between-group differences in the rates of pregnancy loss, maternal, or neonatal complications (all P>.05). CONCLUSION: The Zishen Yutai Pill increased the rate of live birth after fresh embryo transfer compared with placebo. CLINICAL TRIAL REGISTRATION: Chictr.org.cn, Chictr-TRC-14004494.

Using autologous intrauterine platelet-rich plasma to improve the reproductive outcomes of women with recurrent implantation failure.

OBJECTIVE: Reproductive clinics are often faced with cases of repeated implantation failure (RIF). This study evaluated whether platelet-rich plasma (PRP) might improve the implantation outcomes of patients suffering from RIF. METHODS: Thirty women with RIF submitted to frozen-thawed embryo transfers were included in the study. Intrauterine infusions of autologous purified platelet preparations were administered 48 hours prior to embryo transfer. Differences in implantation, clinical pregnancy, and miscarriage rates of cycles with and without PRP infusions were analyzed. RESULTS: The implantation rate seen in the PRP group was 6.7%. No significant difference was found the between the implantation, clinical pregnancy, ongoing pregnancy, and miscarriage rates of frozen-thawed embryo transfers with and without PRP infusion. However, the effect size of PRP infusion (Cohen's d=0.39) on implantation rates revealed a relationship in medium strength. CONCLUSION: Platelet-rich plasma might potentially yield beneficial effects as a safe therapeutic option offered alongside other treatments designed to improve the reproductive outcomes of women with repeated implantation failure.

The effects of acupuncture on pregnancy outcomes of in vitro fertilization with embryo transfer: An interdisciplinary systematic review.

The present systematic review is designed to summarize the evidence concerning the effect of acupuncture on pregnancy outcomes in vitro fertilization with embryo transfer (IVF-ET). We searched MEDLINE, the Wanfang Database, the China Academic Journal Electronic Full-text Database in the China National Knowledge Infrastructure, and the Index to Chinese Periodical Literature. Randomized controlled trials with intervention groups using acupuncture and control groups consisting of no acupuncture or sham (placebo) acupuncture in IVF-ET treatment were selected. Study characteristics were examined from these studies and an intention-to-treat approach was used to extract outcome data from each study. In total, 31 articles including 4450 women passed our selection criteria. The legitimacy, characteristics, and IVF outcomes of the included trials were summarized. Additional Traditional Chinese Medicine (TCM) theory-based, standardized, large-size, randomized, and multicenter trials are necessary prior to any conclusions being drawn on whether TCM can improve IVF outcomes.

Dehydroepiandrosterone supplementation in women undergoing assisted reproductive technology with poor ovarian response. A prospective case-control study.

Objective The effects of dehydroepiandrosterone (DHEA) supplementation in Saudi Arabian women with poor ovarian response (POR) is presently unknown. The present study aimed to assess the benefits of DHEA supplementation in women undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). Methods This was a prospective case-control study involving 62 women who were diagnosed with POR and underwent IVF/ICSI between January 2012 and June 2016. The positive influence of DHEA in 34 women, compared with 28 women without supplementation, was defined as improvements in the number of oocytes retrieved, the fertilization rate, the number of grade I embryos generated and the pregnancy rate. Results Both groups were evenly matched for age, body mass index and laboratory test parameters. There were statistically significant differences between the groups with and without DHEA supplementation for oocyte yield (6.35 ± 2.41 versus 3.98 ± 3.2), Grade I embryos generated (55% versus 30%), positive pregnancy rate (21/34 versus 10/28), and live birth rate (18/34 versus 4/28). Conclusion DHEA supplementation in women with POR had a positive effect on hormonal profiles, the quality of the endometrium, the number of oocytes retrieved, the quality of embryos, and the pregnancy and live birth rates.

[The effect of warm needling pretreatment for endometrial receptivity of frozen embryo transfer].

OBJECTIVE: To explore the effect of warming needling pretreatment for endometrial receptivity before frozen-thawed embryo transfer (FET). METHODS: Fifty-six repeatedly embryo transfer (ET) failure patients with ultrasound showing follicular phase endometrium of C type, hysteroscopy examination presenting endometritis were randomly assigned into an observation group (25 cases) and a control group (31 cases). The patients in the observation group three months before ET were treated with antibiotics in the menstrual period, warming needle (once a day) at Zhongwan (CV 12), Tianshu (ST 25), Guanyuan (CV 4), Zhongji (CV 3), Zigong (EX-CA 1), Liangqiu (ST 34), Zusanli (ST 36), Shangjuxu (ST 37), Xiajuxu (ST 39) after menstruation until the ovulation stopped, and oral administration of progesterone was applied after ovulation. The patients in the control group three months before ET were treated with antibiotics in the menstrual period, and oral administration of progesterone was applied after ovulation. Continuous three menstrual periods were carried out for the both groups. The changes of endometrial thickness, type and endometrial blood flow and the outcome of FET were observed. RESULTS: Endometrial morphology and blood flow were improved after treatment in the two groups (all P<0.01), with better results in the observation group (both P<0.01). The embryo transplantation rate and pregnancy rate in the observation group were higher than those in the control group (both P<0.01), and the early abortion rate decreased (P<0.01). CONCLUSIONS: Warm needling may improve endometrial receptivity, embryo transplantation rate and pregnancy rate and decrease early abortion rate by regulating endometrial morphology and blood flow.

Pregnancy outcomes of women randomized to receive real versus placebo acupuncture on the day of fresh or frozen-thawed embryo transfer.

INTRODUCTION: Acupuncture is commonly used in various aspect of Western medicine in recent years including in-vitro fertilization (IVF) treatment. Although there are many clinical trials of acupuncture in IVF and the Cochrane meta-analysis did not find benefit of adjuvant acupuncture for IVF, there is no report on the pregnancy outcomes of women who had received acupuncture during their IVF treatment. OBJECTIVES: To compare the pregnancy outcomes of women randomized to receive real versus placebo acupuncture during their IVF treatment. METHODS: A retrospective chart review was performed on the 212 women with on-going pregnancies after receiving real or placebo acupuncture by sterile disposable stainless steel needles or Streitberger's placebo needles to the acupoints before and after the embryo transfer on the day of fresh or frozen-thawed embryo transfer. The pregnancy outcomes were obtained from the Hospital Authority Clinical Management System for deliveries in the public sector or from a self-returned questionnaire if those in the private sector. RESULTS: No significant differences were found between the demographics of the two groups including their age, gravida, parity and the duration of subfertility. Maternal adverse outcomes including gestational diabetes and hypertensive disorder were comparable for the real acupuncture group (35.3% and 4.4% respectively) and the placebo acupuncture group (39.7% and 5.5% respectively). None of the patients had placenta accreta. The preterm delivery (<37 weeks gestation) rate in the real acupuncture group (23/86, 26.7%) was similar to that in the placebo acupuncture group (25/97, 25.8%). No statistical significant difference was found in the mode of delivery. There were no significant differences between the two groups for Apgar scores and birthweight. CONCLUSION: Acupuncture during IVF treatment does not influence pregnancy outcomes.

Massage therapy improves in vitro fertilization outcome in patients undergoing blastocyst transfer in a cryo-cycle.

CONTEXT: Massage therapy is increasingly used to relieve physical and mental discomfort and is suggested as a safe therapeutic modality, without any significant risks or any known side effects. Although a multitude of complementary therapies, such as acupuncture, are applied in reproductive medicine, no information is available with regard to the application of massage as an adjuvant therapy in assisted-reproduction techniques (ARTs). OBJECTIVES: This study was intended to assess the effectiveness of a deep relaxation (andullation) therapy based on oscillating vibrations when used prior to embryo transfer (ET) in in vitro fertilization (IVF) cryo-cycles. DESIGN: The research team designed a retrospective, observational study. Participants willing to undergo the massage treatment were allocated to the intervention (andullation) group. SETTING: The study was performed at the IVF Centers Prof. Zech-Bregenz in Bregenz, Austria. PARTICIPANTS: A total of 267 IVF patients, with a mean age of 36.3 y, participated in this single-center study. INTERVENTION: All patients receiving a transfer of vitrified and warmed blastocysts between January and December 2012 were included in the evaluation. Prior to ET, the andullation group received a standardized program of therapy-a 30-min, deep relaxation massage on an oscillating (vibrating) device, whereas the control group did not. OUTCOME MEASURES: To determine efficacy, the primary outcomes that the study measured were (1) pregnancy rates (PRs), by testing urine and obtaining a positive ß-human chorionic gonadotropin (ß-hCG); and (2) ongoing, pregnancies (oPR), by observation of fetal heartbeat and birth rates (BR) as well as miscarriage rates. The patients' medical histories and types of infertility as well as the quality of the embryo transfers (ETs) were evaluated. RESULTS: In patients using the massage therapy prior to ET, significantly higher PRs, oPRs, and BRs were observed compared with the control group-PR: 58.9% vs 41.7%, P<.05; oPR: 53.6% vs 33.2%, P<.01; and BR: 32.0% vs 20.3%, P<.05. No differences were detected among groups for patients' ages, hormonal substitution protocols, endometrium structures and buildups, quality of transferred embryos, or quality of transfers. No adverse effects were noted in the massage group. CONCLUSIONS: The research team's results suggested that andullation therapy prior to blastocyst transfer in a cryo-cycle improves embryo implantation, most likely due to a reduction in stress (ie, a relaxation effect on patients), a reduction in uterine contractions, and, probably, an enhancement of the blood flow in the abdominal region. These findings provide support for use of andullation as a complementary therapy for ART.

The effect of medical clowning on pregnancy rates after in vitro fertilization and embryo transfer.

This experimental prospective quasi-randomized study examining the impact of a medical clowning encounter after embryo transfer (ET) after in vitro fertilization (IVF) found that the pregnancy rate in the intervention group was 36.4%, compared with 20.2% in the control group (adjusted odds ratio, 2.67; 95% confidence interval, 1.36-5.24). Medical clowning as an adjunct to IVF-ET may have a beneficial effect on pregnancy rates and deserves further investigation.

Influence of acupuncture stimulation on pregnancy rates for women undergoing embryo transfer.

OBJECTIVE: To evaluate the effects of acupuncture on clinical pregnancy rates for women undergoing ET. DESIGN: Single-blind, randomized controlled trial using a noninvasive sham acupuncture control. SETTING: Repromed, The Reproductive Medicine Unit of The University of Adelaide. PATIENT(S): Women undergoing IVF. INTERVENTION(S): Women were randomly allocated to acupuncture or noninvasive sham acupuncture with the placebo needle. All women received three sessions, the first undertaken on day 9 of stimulating injections, the second before ET, and the third immediately after ET. MAIN OUTCOME MEASURE(S): The primary outcome was pregnancy. Secondary outcomes were implantation, ongoing pregnancy rate at 18 weeks, adverse events, and health status. RESULT(S): Two hundred twenty-eight subjects were randomized. The pregnancy rate was 31% in the acupuncture group and 23% in the control group. For those subjects receiving acupuncture, the odds of achieving a pregnancy were 1.5 higher than for the control group, but the difference did not reach statistical significance. The ongoing pregnancy rate at 18 weeks was higher in the treatment group (28% vs. 18%), but the difference was not statistically significant. CONCLUSION(S): There was no significant difference in the pregnancy rate between groups; however, a smaller treatment effect can not be excluded. Our results suggest that acupuncture was safe for women undergoing ET.

Acupuncture on the day of embryo transfer significantly improves the reproductive outcome in infertile women: a prospective, randomized trial.

OBJECTIVE: To evaluate the effect of acupuncture on reproductive outcome in patients treated with IVF/intracytoplasmic sperm injection (ICSI). One group of patients received acupuncture on the day of ET, another group on ET day and again 2 days later (i.e., closer to implantation day), and both groups were compared with a control group that did not receive acupuncture. DESIGN: Prospective, randomized trial. SETTING: Private fertility center. PATIENT(S): During the study period all patients receiving IVF or ICSI treatment were offered participation in the study. On the day of oocyte retrieval, patients were randomly allocated (with sealed envelopes) to receive acupuncture on the day of ET (ACU 1 group, n = 95), on that day and again 2 days later (ACU 2 group, n = 91), or no acupuncture (control group, n = 87). INTERVENTION(S): Acupuncture was performed immediately before and after ET (ACU 1 and 2 groups), with each session lasting 25 minutes; and one 25-minute session was performed 2 days later in the ACU 2 group. MAIN OUTCOME MEASURE(S): Clinical pregnancy and ongoing pregnancy rates in the three groups. RESULT(S): Clinical and ongoing pregnancy rates were significantly higher in the ACU 1 group as compared with controls (37 of 95 [39%] vs. 21 of 87 [26%] and 34 of 95 [36%] vs. 19 of 87 [22%]). The clinical and ongoing pregnancy rates in the ACU 2 group (36% and 26%) were higher than in controls, but the difference did not reach statistical difference. CONCLUSION(S): Acupuncture on the day of ET significantly improves the reproductive outcome of IVF/ICSI, compared with no acupuncture. Repeating acupuncture on ET day +2 provided no additional beneficial effect.

Impact of hypnosis during embryo transfer on the outcome of in vitro fertilization-embryo transfer: a case-control study.

OBJECTIVE: To investigate whether hypnosis during ET contributes to successful IVF/ET outcome. DESIGN: Case-control clinical study. SETTING: Academic Fertility and IVF Unit, Soroka Medical Center, Beer-Sheva, Israel. PATIENT(S): Infertile couples undergoing IVF. INTERVENTION(S): Ninety-eight IVF/ET cycles with hypnosis during the ET procedure were matched with 96 regular IVF/ET cycles. MAIN OUTCOME MEASURES: Comparison of clinical pregnancy and implantation rates between the two groups. RESULT(S): We obtained 52 clinical pregnancies out of 98 cycles (53.1%) with an implantation rate of 28% among hypnosis IVF/ET cycles, and 29 out of 96 (30.2%) clinical pregnancies and an implantation rate of 14.4% in the control cycles. Our overall IVF program pregnancy rate for the same period was 32.1%. Logistic regression analysis was performed emphasizing the positive contribution of hypnosis to the IVF/ET conception rates. CONCLUSION(S): This study suggests that the use of hypnosis during ET may significantly improve the IVF/ET cycle outcome in terms of increased implantation and clinical pregnancy rates. Furthermore, it seems that the patients' attitude to the treatment was more favorable.

Embryo transfer by midwife or gynecologist: a prospective randomized study.

BACKGROUND: Embryo transfer (ET) in assisted reproduction treatments has traditionally been performed by gynecologists in the Nordic countries. As gynecologists often have a busy schedule, midwives and nurses have become increasingly important in performing the treatment, providing subject information, ultrasound monitoring and assistance at ET. As part of the continuous development of our IVF treatment we have carried out a prospective randomized pilot study where either a midwife or a gynecologist has performed ET. The aim of this study was to see if a skilled IVF midwife could perform ET with similar results to a gynecologist. METHODS: On the day of oocyte aspiration the subjects were randomized, by means of closed envelopes, for ET to be performed either by a midwife or a gynecologist. A total of 102 subjects were included in the study, 51 for ET by a skilled midwife and 51 by a gynecologist. There were no differences in the groups in respect to ET routine and catheters used. RESULTS: No significant differences were observed in subject characteristics as regards age, method of pituitary down-regulation or proportion of IVF/ICSI cycles. Similar clinical pregnancy rates between ETs performed by midwives vs. gynecologists, 31% vs. 29%, respectively, were seen. Subject experience as judged by a questionnaire also showed high acceptance of ET by a midwife. CONCLUSION: The results show that it is a feasible option to allow midwives to carry out ETs.