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

NCT06708923 | Completed DMC

• 1 other identifier: CS/HV/24/36
• Study Type: interventional
• Target: 1,969
• Locations: 1 country
• Sites: 1

Brief Summary

Title: Evaluating the Effectiveness of Acupuncture on Pregnancy Outcomes in Recurrent Implantation Failure (RIF) Patients Undergoing In Vitro Fertilization (IVF): A Large Cohort Study Objective: This study aims to assess the efficacy of acupuncture in improving pregnancy outcomes, including clinical pregnancy rate (CPR), ongoing pregnancy rate (OPR), and live birth rate (LBR), in patients who have experienced recurrent implantation failure (RIF) during frozen embryo transfer (FET) cycles. Background: Recurrent implantation failure (RIF) is a significant challenge in assisted reproductive technologies (ART), affecting approximately 15% of IVF patients. The causes of RIF include uterine factors, embryo quality issues, and immune dysfunctions. Acupuncture, a traditional Chinese medical practice, has gained interest as an adjunctive treatment in IVF, potentially enhancing uterine blood flow, regulating hormones, and alleviating stress. While previous studies suggest a positive impact of acupuncture on IVF outcomes, its role in patients with RIF remains unclear, particularly in Vietnam, where its integration into modern fertility treatments is emerging. Methods: Design: Retrospective cohort study. Setting: IVF Department, Hung Vuong Hospital, Ho Chi Minh City. Participants: 1,969 IVF cycles from RIF-diagnosed patients between January 2019 and December 2023, divided into two groups: those who received acupuncture and those who did not. Interventions: Acupuncture sessions were performed 25 minutes before and after embryo transfer, targeting specific acupoints (e.g., Baihui, Guanyuan, Sanyinjiao). Standardized hormonal protocols (HRT-E+P) and embryology practices were applied uniformly across all participants. Outcome Measures: CPR, OPR, LBR, biochemical pregnancy rates, and miscarriage rates were analyzed. Statistical Analysis: Descriptive statistics summarized baseline characteristics. Logistic regression was used to evaluate the association between acupuncture and pregnancy outcomes, adjusting for potential confounders such as age, BMI, and number of prior failed cycles. Results (Preliminary): The study hypothesizes that patients receiving acupuncture will demonstrate improved CPR, OPR, and LBR compared to non-acupuncture counterparts. Previous research has suggested a trend toward higher clinical pregnancy rates with acupuncture, but statistical significance and the mechanisms behind these effects require further exploration. Ethical Considerations: Patient data were anonymized, and the study was approved by the institutional ethics committee. Participation was voluntary, with informed consent obtained prior to treatment. Conclusions: This research seeks to provide robust evidence on the integration of acupuncture into fertility treatment protocols for RIF patients, addressing a critical gap in both global and Vietnamese reproductive healthcare. If proven effective, acupuncture could become a valuable complementary therapy in enhancing IVF success rates. This study represents a crucial step toward combining traditional and modern medical practices to improve reproductive outcomes.

Conditions

Infertility (IVF Patients); Acupuncture

Keywords

Recurrent Implantation Failure (RIF); Acupuncture; In Vitro Fertilization (IVF)

Outcome Measures

Primary Outcomes (1)

• Clinical Pregnancy Rate (CPR)

  The proportion of participants achieving a clinical pregnancy, defined as the presence of a gestational sac observed via ultrasound after frozen embryo transfer (FET).

  6-8 weeks post-embryo transfer.

Secondary Outcomes (2)

• Ongoing Pregnancy Rate (OPR)

  12 weeks post-embryo transfer.

• Live Birth Rate (LBR)

  Approximately 9 months post-embryo transfer.

Study Arms (1)

IVF with Acupuncture Group: Patients undergoing IVF cycles with acupuncture performed before and aft

EXPERIMENTAL

IVF with Acupuncture Group: This group includes patients who underwent IVF cycles with acupuncture performed at two key time points: Before Embryo Transfer: Acupuncture was administered 25 minutes prior to transfer at specific acupoints (e.g., Baihui, Guanyuan, Sanyinjiao) to enhance endometrial receptivity and reduce stress. After Embryo Transfer: A second acupuncture session was conducted immediately following the transfer at additional acupoints (e.g., Zusanli, Taichong) to support implantation and relaxation. IVF without Acupuncture Group: This group includes patients who underwent IVF cycles without any acupuncture treatment. Their IVF procedures followed standard clinical protocols for frozen embryo transfer (FET), including hormonal preparation of the endometrium and embryo transfer, without any complementary therapies. The study retrospectively compares clinical outcomes, including clinical pregnancy rate (CPR), ongoing pregnancy rate (OPR), and live birth rate (LBR), betwee

Procedure: Intervention Name: Acupuncture Therapy Before and After Embryo Transfer Description: The intervention involves acupuncture therapy performed at two key time points during the IVF cycle: 25 minutes be

Interventions

Intervention Name: Acupuncture Therapy Before and After Embryo Transfer Description: The intervention involves acupuncture therapy performed at two key time points during the IVF cycle: 25 minutes be PROCEDURE

Acupuncture Therapy Before and After Embryo Transfer This intervention consists of acupuncture sessions designed to support implantation and improve pregnancy outcomes during frozen embryo transfer (FET) cycles. Procedure: Acupuncture is performed using sterile, single-use needles by certified practitioners trained in reproductive health. Sessions occur at two critical time points: Before Embryo Transfer: A 25-minute session targeting acupoints such as Baihui (DU20), Guanyuan (CV4), and Sanyinjiao (SP6) to enhance endometrial receptivity and reduce stress. After Embryo Transfer: A second 25-minute session targeting acupoints such as Zusanli (ST36) and Taichong (LR3) to promote implantation and relaxation. Purpose: Improve uterine blood flow and receptivity. Regulate hormonal balance to optimize the implantation environment. Reduce psychological stress associated with IVF procedures. This intervention is compared retrospectively to standard IVF protocols without acupuncture to asses

IVF with Acupuncture Group: Patients undergoing IVF cycles with acupuncture performed before and aft

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Women diagnosed with recurrent implantation failure (RIF), defined as the absence of clinical pregnancy after at least three transfers of good-quality embryos.
• Patients undergoing frozen embryo transfer (FET) cycles with at least one viable frozen embryo.
• Endometrial preparation using hormone replacement therapy (HRT-E+P).
• Complete consent form signed by both partners and the attending physician, as per IVF protocol at Hung Vuong Hospital.
• Availability of complete clinical and embryological records from January 2019 to December 2023.

You may not qualify if:

• Structural uterine abnormalities, including untreated septate uterus or uterine malformations.
• Patients undergoing preimplantation genetic testing (PGT) cycles.
• Use of donor eggs or sperm.
• Presence of untreated endocrine disorders, including but not limited to hyperthyroidism, hypothyroidism, diabetes, and hypertension.
• Patients lacking consent for data usage in the study or incomplete clinical records.
• Criteria for Recurrent Implantation Failure (RIF)
• Definition:
• According to the European Society of Human Reproduction and Embryology (ESHRE), recurrent implantation failure (RIF) is defined as the inability to achieve a clinical pregnancy after transferring good-quality embryos across multiple in vitro fertilization (IVF) cycles.
• Criteria for RIF Diagnosis:
• Number of Transfers: Failure to achieve pregnancy after at least three embryo transfers (fresh or frozen), with a minimum of 1-2 good-quality embryos transferred each time.
• Total Number of Embryos: Alternatively, RIF can be defined as failure to achieve pregnancy after transferring at least four good-quality embryos in total.
• Possible Causes:
• RIF can result from factors related to the embryo, uterus, or other conditions, such as:
• Embryo quality issues (e.g., genetic abnormalities or poor development). Uterine abnormalities (e.g., insufficient endometrial thickness or structural anomalies).
• Immunological or hematological factors affecting implantation. These criteria guide the identification of patients who may benefit from further investigation or specialized treatments, such as those evaluated in this study.

Sponsors & Collaborators

• Hung Vuong Hospital: lead

Study Sites (1)

Hung Vuong Hospital

Ho Chi Minh City, 70000, Vietnam

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• PHUONG HUY TRAN, MSc

  IVF Hung Vuong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Infertility Specialist, Department of Infertility, Hung Vuong Hospital

Model Details: This study employs an Observational Retrospective Cohort Design to investigate the impact of acupuncture on pregnancy outcomes in patients diagnosed with recurrent implantation failure (RIF) undergoing frozen embryo transfer (FET) cycles. Participants are categorized into two cohorts: Acupuncture Cohort: Patients who received acupuncture treatments before and after embryo transfer during their IVF cycle. Non-Acupuncture Cohort: Patients who did not receive acupuncture during their IVF cycle. The study analyzes historical medical records to compare key clinical outcomes between the two cohorts, including clinical pregnancy rate (CPR), ongoing pregnancy rate (OPR), and live birth rate (LBR). No experimental interventions are conducted during the study period, as it relies on previously collected data. Statistical methods are applied to adjust for confounding variables such as age, BMI, and number of prior failed cycles to ensure accurate comparisons and reliable conclusions.

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 29, 2024
• Study Start: January 1, 2019
• Primary Completion: December 31, 2023
• Study Completion: January 1, 2024
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)