Role of assisted hatching in in vitro fertilization: a guideline.
General
Guideline Title
Role of assisted hatching in in vitro fertilization: a guideline.
Bibliographic Source(s)
- Practice Committee of the American Society for Reproductive Medicine, Practice Committee of the Society for Assisted Reproductive Technology. Role of assisted hatching in in vitro fertilization: a guideline. Fertil Steril. 2014 Aug;102(2):348-51. [19 references] PubMed
Guideline Status
This is the current release of the guideline.
This guideline meets NGC’s 2013 (revised) inclusion criteria.
NEATS Assessment
Disclosure of Guideline Funding Source
- No
Disclosure and Management of Financial Conflict of Interests
- 4
Guideline Development Group Composition: Multidisciplinary Group
- Yes
Guideline Development Group Composition: Methodologist Involvement
- Unknown
Guideline Development Group Composition: Patient and Public Perspectives
- 1
Use of a Systematic Review of Evidence: Search Strategy
- 3
Use of a Systematic Review of Evidence: Study Selection
- 3
Use of a Systematic Review of Evidence: Synthesis of Evidence
- 5
Evidence Foundations for and Rating Strength of Recommendations: Grading the Quality or Strength of Evidence
- 3
Evidence Foundations for and Rating Strength of Recommendations: Benefits and Harms of Recommendations
- 5
Evidence Foundations for and Rating Strength of Recommendations: Evidence Summary Supporting Recommendations
- 5
Evidence Foundations for and Rating Strength of Recommendations: Rating the Strength of Recommendations
- 3
Specific and Unambiguous Articulation of Recommendations
- 5
External Review
- 2
Updating
- 2
Recommendations
Major Recommendations
Definitions for the level of the evidence ( Level I-III ) and strength of the recommendations ( Grade A-C ) are given at the end of the “Major Recommendations” field.
Summary
- Despite its widespread and longtime use, there have been a limited number of studies that have examined the effect of assisted hatching (AH) on live birth rate (LBR). As a result, there is insufficient evidence that AH improves birth rates ( Level C ).
- There is good evidence that AH slightly improves clinical pregnancy rates (CPR) in poor prognosis patients, including those with prior failed in vitro fertilization (IVF) cycles and who have a poor prognosis ( Level A ).
- AH appears to be associated with an increased risk of multiple pregnancy ( Level A ), but there is insufficient evidence that it is associated with an increased risk of monozygotic (MZ) twin pregnancy ( Level C ).
- Until data about LBR are available and in the context of increased risk of multiple pregnancy, it is premature to recommend AH in all patients with poor prognosis.
Recommendation
AH should not be recommended routinely for all patients undergoing IVF ( Level C ).
Definitions
Level of Evidence
Level I : Evidence obtained from at least one properly designed randomized, controlled trial.
Level II-1 : Evidence obtained from well-designed controlled trials without randomization.
Level II-2 : Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than one center or research group.
Level II-3 : Evidence obtained from multiple time series with or without the intervention. Dramatic results in uncontrolled trials might also be regarded as this type of evidence.
Level III : Opinions of respected authorities based on clinical experience, descriptive studies, or reports of expert committees.
Strength of Recommendations
Level A : There is good evidence to support the recommendations, either for or against.
Level B : There is fair evidence to support the recommendations, either for or against.
Level C : There is insufficient evidence to support the recommendations, either for or against.
Clinical Algorithm(s)
None provided
Scope
Disease/Condition(s)
Infertility
Guideline Category
- Technology Assessment
- Treatment
Clinical Specialty
- Obstetrics and Gynecology
Intended Users
- Advanced Practice Nurses
- Physician Assistants
- Physicians
Guideline Objective(s)
To evaluate the role of assisted hatching in in vitro fertilization (IVF)
Target Population
Women undergoing in vitro fertilization (IVF)
Interventions and Practices Considered
In vitro fertilization (IVF) using assisted hatching ( not recommended routinely )
Major Outcomes Considered
- Clinical pregnancy rates (CPR)
- Live birth rates (LBR)
- Implantation rate
- Monozygotic (MZ) twin pregnancy rate
Methodology
Methods Used to Collect/Select the Evidence
- Hand-searches of Published Literature (Primary Sources)
- Hand-searches of Published Literature (Secondary Sources)
- Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence
A systematic literature search was performed using the following two search strategies:
- (Assisted OR zona hatching OR drilling OR thinning) AND (pregnancy OR implantation OR live birth) AND blastocyst
- Assisted hatching AND in vitro fertilization (IVF) (Humans [Mesh] AND English [lang])
The literature search was performed from 1966 through November 2013. Studies were eligible if they met one the following criteria: primary evidence (clinical trials) which assessed the effectiveness of procedure correlated with an outcome measure (pregnancy, implantation or live birth rates), meta-analyses, and relevant articles from bibliographies of identified articles.
Randomized trials, cohort studies, case control studies and cross-sectional studies written in English were selected for review. Two reviewers screened the papers by title and abstracts. Then full text papers were obtained and reviewed.
Number of Source Documents
A total of 312 articles were identified, of which 68 were included as relevant.
Methods Used to Assess the Quality and Strength of the Evidence
- Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence
Level of Evidence
Level I: Evidence obtained from at least one properly designed randomized, controlled trial.
Level II-1: Evidence obtained from well-designed controlled trials without randomization.
Level II-2: Evidence obtained from well-designed cohort or case-control analytic studies, preferably from more than one center or research group.
Level II-3: Evidence obtained from multiple time series with or without the intervention. Dramatic results in uncontrolled trials might also be regarded as this type of evidence.
Level III: Opinions of respected authorities based on clinical experience, descriptive studies, or reports of expert committees.
Methods Used to Analyze the Evidence
- Review of Published Meta-Analyses
- Systematic Review with Evidence Tables
Description of the Methods Used to Analyze the Evidence
Data were extracted using a standardized form including the following information: author and year of publication, study design, types of participants, sample size, outcomes measured, and study results citing odds ratio (OR) and relative risk (RR) if available.
Quality of the studies was assessed by reviewing the study design, assessment of exposure and outcome, confounders, bias, statistical methods, and reported limitations. The quality of the evidence was evaluated using grading system found in the “Rating Scheme for the Strength of the Evidence” field. The strength of the evidence was evaluated by the guideline committee after reviewing the results of the literature search and recommendations were graded as described in the “Rating Scheme for the Strength of the Recommendations” field.
Methods Used to Formulate the Recommendations
- Not stated
Description of Methods Used to Formulate the Recommendations
Not applicable
Rating Scheme for the Strength of the Recommendations
Strength of Recommendations
Level A : There is good evidence to support the recommendations, either for or against.
Level B : There is fair evidence to support the recommendations, either for or against.
Level C : There is insufficient evidence to support the recommendations, either for or against.
Cost Analysis
A formal cost analysis was not performed and published cost analyses were not reviewed.
Method of Guideline Validation
- Internal Peer Review
Description of Method of Guideline Validation
This document was reviewed by American Society for Reproductive Medicine (ASRM) members, and their input was considered in the preparation of the final document. The Practice Committee and the Board of Directors of the ASRM and the Society for Assisted Reproductive Technology (SART) have approved this report.
Evidence Supporting the Recommendations
Type of Evidence Supporting the Recommendations
The type of supporting evidence is identified and graded for each recommendation (see the “Major Recommendations” field).
Benefits/Harms of Implementing the Guideline Recommendations
Potential Benefits
Many assisted reproductive technology (ART) programs have incorporated the use of assisted hatching (AH) in an effort to improve clinical outcomes. There is good evidence that AH slightly improves clinical pregnancy rates in poor prognosis patients, including those with prior failed in vitro fertilization cycles and who have a poor prognosis.
Potential Harms
- The assisted hatching procedure may be associated with specific complications independent of the in vitro fertilization (IVF) procedure itself, including lethal damage to the embryo and damage to individual blastomeres with reduction of embryo viability. In addition, artificial manipulation of the zona pellucida (ZP) has been associated with an increased risk of monozygotic (MZ) twin pregnancy.
- Despite limited evidence of the benefits or risks, patients whose embryos undergo assisted hatching are often treated with antibiotics and steroids before and after embryo transfer (ET), exposing them to the potential risks and side effects of such treatments.
Qualifying Statements
Qualifying Statements
This report was developed under the direction of the Practice Committee of the American Society for Reproductive Medicine (ASRM) in collaboration with the Society for Assisted Reproductive Technology (SART) as a service to its members and other practicing clinicians. Although this document reflects appropriate management of a problem encountered in the practice of reproductive medicine, it is not intended to be the only approved standard of practice or to dictate an exclusive course of treatment. Other plans of management may be appropriate, taking into account the needs of the individual patient, available resources, and institutional or clinical practice limitations.
Implementation of the Guideline
Description of Implementation Strategy
An implementation strategy was not provided.
Implementation Tools
- Foreign Language Translations
- Patient Resources
- Staff Training/Competency Material
Institute of Medicine (IOM) National Healthcare Quality Report Categories
IOM Care Need
- Getting Better
IOM Domain
- Effectiveness
Identifying Information and Availability
Bibliographic Source(s)
- Practice Committee of the American Society for Reproductive Medicine, Practice Committee of the Society for Assisted Reproductive Technology. Role of assisted hatching in in vitro fertilization: a guideline. Fertil Steril. 2014 Aug;102(2):348-51. [19 references] PubMed
Adaptation
Not applicable: The guideline was not adapted from another source.
Date Released
2014 Aug
Guideline Developer(s)
- American Society for Reproductive Medicine - Nonprofit Organization
Source(s) of Funding
American Society for Reproductive Medicine
Guideline Committee
Practice Committee of the American Society for Reproductive Medicine and Practice Committee of the Society for Assisted Reproductive Technology
Composition of Group That Authored the Guideline
Committee Members : Samantha Pfeifer, MD; Roger Lobo, MD; Rebecca Sokol, MD; Jeffrey Goldberg, MD; Gregory Fossum, MD; Michael Thomas, MD; Margareta Pisarska, MD; Eric Widra, MD; Mark Licht, MD; Jay Sandlow, MD; John Collins, MD; Marcelle Cedars, MD; Mitchell Rosen, MD; Michael Vernon, PhD, HCLD; Owen Davis, MD; William Catherino, MD, PhD; Dan Dumesic, MD; Randall Odem, MD; Clarisa Gracia, MD, MSCE; Kim Thornton, MD; Samantha Butts, MD, MSCE; Robert Rebar, MD; Richard Reindollar, MD; Andrew La Barbera, PhD
Financial Disclosures/Conflicts of Interest
All Committee members disclosed commercial and financial relationships with manufacturers or distributors of goods or services used to treat patients. Members of the Committee who were found to have conflicts of interest based on the relationships disclosed did not participate in the discussion or development of this document.
Guideline Status
This is the current release of the guideline.
This guideline meets NGC’s 2013 (revised) inclusion criteria.
Guideline Availability
Available from the American Society for Reproductive Medicine Web site.
Availability of Companion Documents
Continuing medical education (CME) credit related to this guideline is available from the American Society for Reproductive Medicine Web site.
Patient Resources
The following is available:
- Assisted hatching. Fact sheet. Birmingham (AL): American Society for Reproductive Medicine; 2015. 1 p. Available from the ReproductiveFacts Web site. Also available in Spanish from the ReproductiveFacts Web site.
Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline’s content.
NGC Status
This NGC summary was completed by ECRI Institute on March 27, 2017. The information was verified by the guideline developer on April 17, 2017.
This NEATS assessment was completed by ECRI Institute on June 22, 2017. The information was verified by the guideline developer on July 25, 2017.
Copyright Statement
This NGC summary is based on the original guideline, which is subject to the guideline developer’s copyright restrictions.
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