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. 2020 Oct 22;2020(10):CD002125. doi: 10.1002/14651858.CD002125.pub4

An 2015.

Study characteristics
Methods Parallel RCT
Participants Country: China
Site: Center for Reproductive Medicine, Gansu Provincial Hospital of Maternity and Children Healthcare, Lanzhou, China.
Participants: 229 women with recently diagnosed hydrosalpinx by either HSG or laparoscopy prior to undergoing IVF‐ET, of which Group A (94 women) underwent transvaginal aspiration of hydrosalpinx and auricular point sticking (a form of acupuncture); Group B (89 women) underwent transvaginal aspiration of hydrosalpinx only; and Group C (46 women) underwent no intervention.
Mean age: range 20 to 40 years.
Inclusion: women with hydrosalpinx diagnosed by contrast imaging or laparoscopy, aged 20 to 40 years, wishing to conceive.
Exclusion: patients with any of the following ‐ acute pelvic infection; high blood pressure; endocrine disease (e.g. diabetes, hyperthyroidism, hyperprolactinaemia, Stein‐Leventhal syndrome); endometriosis; and adenomyosis.
IVF protocol: A daily injection of GnRH agonist at a dose of 3.75 mg i.m. was administered from day 2 of the menstrual cycle. On day 7 of the cycle, a transvaginal ultrasound was performed to measure endometrial thickness. Following 30 days of GnRH agonist injections, 2 mg estradiol valerate was administered p.o. once daily for four days and increased by 1 mg at a time until endometrial thickness reached 8 to 10 mm. No details were provided regarding oocyte collection, embryo transfer or luteal phase support.
Interventions Group A underwent transvaginal aspiration of hydrosalpinx and auricular point sticking; Group B underwent transvaginal aspiration of hydrosalpinx only; and Group C received no intervention.
No further details of the interventions are provided.
Outcomes
  1. Clinical pregnancy rate (as confirmed by ultrasound at 35 days) per woman randomised (n/n)

  2. Multiple pregnancy rate (n/n)

  3. Early miscarriage rate (not defined) (n/n)

  4. Ectopic pregnancy rate (not defined) (n/n)

Notes We did not obtain responses after emailing the authors to obtain clarification and further details of their methodology and outcomes.
The authors did not specify a trial registration number.
It is unclear whether power calculation was undertaken.
There is no mention of any funding sources involved in the study.
It is unclear whether an intention‐to‐treat analysis was performed.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Random digit table"
Allocation concealment (selection bias) Unclear risk Not specified.
Blinding of participants and personnel (performance bias)
All outcomes High risk No blinding performed.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not specified.
Incomplete outcome data (attrition bias)
Intention to treat for primary outcome? High risk Out of 229 women randomised, only 217 were analysed. No explanation was given for the 12 participants whose data were not analysed.
Selective reporting (reporting bias) Unclear risk Not specified.
Other bias Unclear risk Apart from stating that participants' age and duration of infertility did not differ across all groups, no further mention is made regarding differences in demographic characteristics.