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. 2020 Aug 14;2020(8):CD013063. doi: 10.1002/14651858.CD013063.pub2

Kamath 2015.

Study characteristics
Methods Study design: RCT
Setting: university level infertility centre in India
Period: The duration of the study was 3 years (from September 2011 to June 2014)
Participants Eligible 72 women, 12 declined to participate
Inclusion criteria: all consecutive women who were due for a fresh blastocyst transfer and had supernumerary embryos available for cryopreservation, patients with previously unsuccessful fresh blastocyst transfers and those who did not undergo fresh transfer due to high risk of OHSS, women who had a successful outcome previously and were interested in having another child.
60 women undergoing vitrified warmed blastocyst transfers, were randomised to SEET (n = 30) or control (n = 30)
Baseline characteristics:
Study group (n = 30)
Age (Years) 29.9 (4.0)
Body Mass Index (kg/m2) 24.51 (3.36)
Duration of infertility (years) 7.55 (3.36)
Total dose of gonadotrophins (IU) 1914.17 (900.35)
Estradiol levels on trigger day (pg/ml) 3282.42 (2154.68
Number of MII oocytes 13.05 (5.34)
Number of fertilised oocytes 10.59 (4.38)
Number of blastocysts transferred 2.1 (0.5)
Number of good quality blastocysts transferred (≥ 3AA) 1.8 (0.5)
Control group (n = 30)
Age (Years) 29.8 (4.3)
Body Mass Index (kg/m2) 24.49 (3.26)
Duration of infertility (years) 8.58 (3.62)
Total dose of gonadotrophins (IU) 1792.50 (764.52)
Estradiol levels on trigger day (pg/ml) 2737.62 (1353.83)
Number of MII oocytes 13.53 (5.22)
Number of fertilised oocytes 10.28 (3.64)
Number of blastocysts transferred 1.9 (0.6)
Number of good quality blastocysts transferred (≥ 3AA) 1.7 (0.6)
Type of infertility Primary 14 Secondary 16
Previous ART attempt Yes 13 No 17
ART protocol Antagonist 13 Long protocol 17 Ultralong protocol 0
Type of infertility Primary 19 Secondary 11
Previous ART attempt Yes 9 No 21
ART protocol Antagonist 10 Long protocol 16 Ultralong protocol 4
Interventions Uterine flushing with supernatant embryo culture medium in vitrified warmed blastocyst transfer cycles compared to direct transfer
In women allocated to the SEET group thawed supernatant embryo culture medium was injected into the uterine cavity transcervically two days prior to the planned blastocyst transfer. In the control group, direct vitrified warmed blastocyst transfer was performed.
Outcomes Main outcome measure(s):
Positive (βhCG‐ biochemical) pregnancy rate per embryo transfer
(primary) Clinical pregnancy rate per embryo transfer (singleton‐ twins‐ triplet)
Implantation rate per embryo
Multiple pregnancy rate per clinical pregnancy
Miscarriage rate per clinical pregnancy
Live birth rate per embryo transfer
Notes Study funding: Research Grant, Christian Medical College, Vellore.
Conflict of interest None to declare.
Authorship role KG and MSK conceived and designed the study.
MM and MSK analysed and interpreted the data.
MM, MSK and KG wrote the manuscript.
KB, NNV, AJ, MM, MK and MSK contributed to data collection and/or performed procedures.
All the authors contributed to write the manuscript.
All the authors approved the final version of the manuscript.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Women entering the trial were randomly distributed, using a computer generated randomisation sequence (blocks of 6) into two groups
The randomisation sequence was generated by a statistician from the institutional biostatistics department
Allocation concealment (selection bias) Low risk Allocation concealment was achieved by using consecutively numbered opaque sealed envelope. Once the women were planned for vitrified thawed transfer, the envelope was opened
Blinding of participants and personnel (performance bias)
All outcomes High risk Authors report the lack of blinding as one of the limitations of the study
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Insufficient information provided to reach a conclusion
Incomplete outcome data (attrition bias)
All outcomes Low risk There were no drop outs in the trial, as reported by authors
All women who entered the trial were available for analysis with no loss to follow up reported (30 in each group)
Selective reporting (reporting bias) Low risk Adverse events reported ‐ expected outcomes analysed‐ published protocol (CTRI/2013/01/003280)
Other bias Low risk The study was registered ‐ methodological rationale ‐ distribution of tasks
The study was approved by the institutional review board.
The trial was registered with the clinical trial registry of India (CTRI/2013/01/003280)
The small sample size was based and adequately powered to detect differences on the clinical pregnancy rate