Evaluation of Acupuncture's Effectiveness on Pregnancy Outcomes in Women with Recurrent Implantation Failure RIF: a Large Cohort Study

Study Title: Evaluating the Effectiveness of Acupuncture on Pregnancy Outcomes in Recurrent Implantation Failure (RIF) Patients Undergoing In Vitro Fertilization (IVF): A Large Cohort Study

Background:

Recurrent implantation failure (RIF) is a complex condition that poses significant challenges to the success of assisted reproductive technology (ART). Defined by the European Society of Human Reproduction and Embryology (ESHRE), RIF occurs when a clinical pregnancy is not achieved after the transfer of good-quality embryos in multiple IVF cycles. Causes include embryo quality, uterine abnormalities, immunological factors, and hormonal imbalances. The psychological and physical stress associated with repeated failures further complicates treatment.

Acupuncture, a traditional Chinese medicine practice, has been used for over 3,000 years to treat various conditions. In the context of infertility, acupuncture is believed to enhance uterine blood flow, regulate endocrine function, and reduce patient stress, thus creating a favorable environment for implantation. While prior studies have suggested that acupuncture may improve IVF outcomes, evidence specific to patients with RIF remains limited, particularly in Vietnam, where it has been integrated into modern reproductive medicine only recently.

Objective:

To investigate the impact of acupuncture on pregnancy outcomes, including clinical pregnancy rate (CPR), ongoing pregnancy rate (OPR), and live birth rate (LBR), in patients with RIF undergoing frozen embryo transfer (FET) cycles.

Study Design:

This is a retrospective cohort study conducted at the IVF Department of Hung Vuong Hospital, a leading center for reproductive medicine in Ho Chi Minh City, Vietnam.

Participants:

The study includes 1,969 IVF cycles performed between January 2019 and December 2023 on patients diagnosed with RIF. Patients were categorized into two groups based on whether they received acupuncture during their treatment cycles.

Inclusion Criteria:

Women diagnosed with RIF, defined as the absence of a clinical pregnancy after three or more embryo transfers using good-quality embryos.

At least one viable frozen embryo available for transfer. Endometrial preparation using hormone replacement therapy (HRT-E+P). Written consent from both partners for participation in IVF treatment.

Exclusion Criteria:

Untreated uterine anomalies (e.g., septate uterus). Preimplantation genetic testing (PGT) cycles. Egg or sperm donation. Unmanaged endocrine disorders (e.g., hyperthyroidism, diabetes). Patients without complete medical records or those who did not consent to the use of their data.

Intervention:

Acupuncture was performed at two critical time points during the FET cycle:

Before Embryo Transfer: A session lasting 25 minutes, targeting acupoints such as Baihui (DU20), Guanyuan (CV4), and Sanyinjiao (SP6), aimed at improving uterine receptivity and reducing stress.

After Embryo Transfer: Another 25-minute session targeting points including Zusanli (ST36) and Taichong (LR3), designed to enhance implantation and maintain relaxation.

Standardized acupuncture protocols were developed based on evidence from global and local studies, ensuring consistency in treatment.

Outcome Measures:

Primary Outcomes:

Clinical pregnancy rate (CPR): Presence of a gestational sac on ultrasound. Ongoing pregnancy rate (OPR): Pregnancy sustained beyond 12 weeks. Live birth rate (LBR): Birth of a viable infant.

Secondary Outcomes:

Biochemical pregnancy rate: Positive beta-hCG levels. Miscarriage rates: Early and late pregnancy losses.

Methodology:

Data Collection: Clinical data were extracted from electronic medical records. Information on patient demographics, IVF history, embryo quality, and acupuncture details were recorded.

Acupuncture Protocol: Acupuncture sessions were performed using sterile, single-use needles by certified practitioners trained in reproductive health.

Data Analysis: Statistical analyses were conducted using Stata 14. Logistic regression models adjusted for confounders, including age, BMI, and number of prior failed cycles, were used to evaluate associations between acupuncture and pregnancy outcomes.

Statistical Analysis Plan:

Descriptive statistics summarized baseline characteristics. Chi-square tests and Fisher's exact tests compared pregnancy outcomes between groups.

Logistic regression analysis adjusted for confounding variables, with results reported as odds ratios (OR) and 95% confidence intervals (CI).

Ethical Considerations:

The study was approved by the institutional ethics committee of Hung Vuong Hospital. All participants provided written informed consent for their data to be used in the study. Data were anonymized to ensure confidentiality.

Significance:

This study aims to provide robust evidence regarding the integration of acupuncture into fertility treatments for patients with RIF. By evaluating its impact on various pregnancy outcomes, the study seeks to address a critical gap in both local and global reproductive healthcare. Findings could inform clinical guidelines and promote a multidisciplinary approach combining traditional and modern medicine to improve IVF success rates.

Potential Impact:

If successful, this study could:

Validate acupuncture as an effective adjunctive therapy for RIF patients. Encourage the adoption of acupuncture in reproductive medicine, enhancing holistic patient care.

Provide insights into optimal acupuncture protocols for maximizing IVF success. This research represents a significant step in bridging traditional medicine with cutting-edge reproductive technologies, offering renewed hope to couples facing infertility challenges.