Assessment

Final

Assessor

DH LV

Inclusion

Date

Exclusion; because: ............................................................

Awaiting; because: .............................................................

Study information

1. Ref ID

2. First author

3. Year

4. Published

Yes No

5. Language

6. Retrieval

Electronic search Handsearched

After citation tracking After contacting author in the field

Notes:

Criteria for eligibility

Participants

Couples undergoing embryo transfer after IVF, ICSI, and/or an embryo thaw cycle

Yes No

Intervention

Embryo transfer with media containing hyaluronic acid or fibrin sealant for embryos · Grown in vitro for 2 to 4 days Grown in vitro for 5 to 6 days Frozen‐thawed · Both fresh and frozen‐thawed

Yes No

Comparison

Embryo transfer with standard media for embryos · Grown in vitro for 2 to 4 days Grown in vitro for 5 to 6 days Frozen‐thawed · Both fresh and frozen‐thawed

Yes No

Outcome

Primary

Live birth rate (per randomly assigned couple)

Yes No

Secondary

Ongoing pregnancy rate (per randomly assigned couple) (12+ weeks viable, fetal heartbeat positive, pregnancy)

Yes No

Clinical pregnancy rate (per randomly assigned couple) (positive pregnancy test, gestational sac on ultrasound)

Yes No

Multiple pregnancy rate (per randomly assigned couple)

Yes No

Additional

Implantation rate (per randomly assigned couple) (gestational sac per embryo transfer)

Yes No

Adverse events (ectopic pregnancies, miscarriage, fetal/congenital defects, pelvic inflammation, or other) (per randomly assigned couple)

Yes No

Notes:

Study characteristics

Design

1. Study design

RCT Parallel (intervention vs control) Cross‐over (participants used as intervention and control groups) .................................. Quotes: ........................................................................................

2. Participant recruitment

Prospective Retrospective Unclear Quotes: ............................................................................................

3. Sampling (How was the sampling group formed?)

Consecutive Non‐consecutive Unclear Quotes: ................................................................................................................

4. Setting

Single‐centre Multi‐centre Country ....................................................................................

Participants: included and excluded

5. Study criteria for participant inclusion

6. Study criteria for participant exclusion

7. Description of control/comparison treatment

8. Power calculation performed and followed

Yes No Unclear Quotes:.................................................................................................................

Notes:

Participants

Baseline characteristics

Age (of female): Not reported

Mean:

SD:

Intervention:

Control:

Subfertility

Primary Secondary Both Not reported

Cause and duration of subfertility

Reported Not reported

Previous IVF and/or ICSI treatment

Reported Not reported

Undergoing IVF or ICSI, or both

IVF ICSI Both

Age group analysis

Yes, define: No

Notes:

Flow chart of participants

Remarks:

Intervention

Embryo transfer after IVF, ICSI, and/or frozen‐thaw cycle

1. Time of randomisation during cycle

Before commencement of treatment cycle After commencement of treatment and before fertilisation check From fertilisation check to day of embryo transfer On day of embryo transfer

2. Nature of intervention

Addition of hyaluronic acid to embryo transfer medium; concentration was ....... Addition of fibrin sealant to embryo transfer medium; concentration was .................

3. Exposure time to hyaluronic acid or fibrin sealant before ET

..........................................................................

4. Timing of intervention

Early in embryo development: mean cleavage stage (day 2 to and including day 4) Late in embryo development: blastocyst stage (days 5 and 6) Both cleavage and blastocyst stages in embryo development

5. Frozen‐thaw protocol

Yes No Unclear

6. Including oocyte donations

Yes No Unclear

7. Culture and transfer (with and without adherence compound) medium brand

............................................................................

8. Mean number of embryos transferred

.............................................

Not reported

9. Pregnancy determination

Foetal heartbeat

Demonstration of gestational sac on ultrasound scan

Pregnancy test

Not reported

Notes:

Primary outcomes

Total occurrence N = Total non‐occurrence N =

Notes:

Secondary outcomes

Total occurrence N = Total non‐occurrence N =

Notes:

Total occurrence N = Total non‐occurrence N =

Notes:

Total occurrence N = Total non‐occurrence N =

Notes:

Additional outcomes

Implantation rate (gestational sacs per embryos transferred)

Occurrence of outcome

Non‐occurrence of outcome

Treatment

Control

Total (by event)

Notes:

Adverse events

Ectopic pregnancy

Occurrence of outcome

Non‐occurrence of outcome

Total (by group)

Treatment

Control

Total (by event)

Notes:

Miscarriage

Occurrence of outcome

Non‐occurrence of outcome

Total (by group)

Treatment

Control

Total (by event)

Notes:

Foetal/congenital defects

Occurrence of outcome

Non‐occurrence of outcome

Total (by group)

Treatment

Control

Total (by event)

Notes:

Pelvic inflammation

Occurrence of outcome

Non‐occurrence of outcome

Total (by group)

Treatment

Control

Total (by event)

Notes:

Other adverse events

Occurrence of outcome

Non‐occurrence of outcome

Total (by group)

Treatment

Control

Total (by event)

Notes:

Other outcomes studied

Miscarriage

Occurrence of outcome

Non‐occurrence of outcome

Total (by group)

Treatment

Control

Total (by event)

Notes:

Miscarriage

Occurrence of outcome

Non‐occurrence of outcome

Total (by group)

Treatment

Control

Total (by event)

Notes:

Risk of bias assessment

Selection bias

Was the allocation sequence adequately generated? Explain the method used by the study authors to assess whether it should produce comparable groups

Yes No Unclear

Was participant allocation concealment adequate? Explain. (adequate: central computer randomisation, on‐site assignment can be determined only after participant data are entered; serially numbered, sealed opaque envelopes)

Yes No Unclear

How was randomisation performed?

Computer generated Random numbers table Not stated

Selective outcome reporting

Are reports of the study free of the suggestion of selective outcome reporting? Explain (compare Methods with Results) ............................................................

Yes No Unclear

Detection bias

Was follow‐up long enough?

Yes No Unclear

Was the clinician or nurse blinded?

Yes No Unclear

Was the scientist blinded?

Yes No Unclear

Was the participant blinded?

Yes No Unclear

Attrition bias

Was loss to follow‐up accounted for? (Is it stated in the study?)

Yes No Unclear

Was an intention‐to‐treat analysis performed?

Yes No Unclear

Source of funding

Was the source of funding stated?

Yes No Unclear

Other remarks on quality