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. 2022 Mar 1;12(3):e057122. doi: 10.1136/bmjopen-2021-057122

Table 1.

Time schedule and assessment items of participant enrolment and follow-ups

Time Items assessment
Pretreatment
The first visit: the preceding 4 weeks
  1. Informed consent, basic information, medical history physical examination and routine preoperative investigations of each participant will be obtained.

  2. The conditions of uterine cavity including endometrial thickness and endometrial pattern will be assessed via transvaginal ultrasound.

The day of treatment
The second visit: the day of operation Lower abdominal liposuction for preparation of SVF and hysteroscopy will be performed at first. Then, 2–3 mL SVF will be transplanted into uterine cavity and routine postoperative care will be received. Intrauterine fluid was aspirated 1 day after operation. All side effects or adverse events will be observed and recorded during this procedure.
Post-treatment
The third visit:
7–10 days
  1. Basic information, medical history (ongoing health problems and drug history) and physical examination of each participant will be reviewed.

  2. All side effects or adverse events will be recorded.

  3. Endometrial thickness and morphology will be evaluated via transvaginal ultrasound.

  4. 4 mL venous blood will be taken and C reactive protein, alanine aminotransferase and phosphocreatine kinase will be detected to confirm the presence of inflammatory condition.

The fourth visit and the fifth visit:
1 month ±3 days and 2 weeks after the second menstrual cycle
(Both in follicular phase of menstrual cycle)
  1. Medical history (ongoing health problems and drug history) and physical examination of each participant will be reviewed.

  2. All side effects or adverse events will be recorded.

  3. The changes of the volume or duration of the menses will be recorded.

  4. Endometrial thickness and morphology will be evaluated via transvaginal ultrasound.

  5. Implantation and clinical pregnancy outcomes will be assessed and recorded if necessary.

The sixth visit:
1 week after the third menstrual cycle
(Follicular phase)
  1. The evaluation items are the same as those in the previous two visits. If there are clinical indications in this visit, hysteroscopy will be performed again to observe the morphological changes of uterine cavity and endometrium, and all the imaging data will be retained for comparison with those before treatment.

Telephone follow-up:
Every 6 months for 2 years
(Follow-up phone call at 6 months, 1 year, one and half year, 2 years after treatment)
  1. Ongoing health problems and drug history will be reviewed.

  2. All side effects or adverse events will be recorded.

  3. The changes of the volume or duration of the menses will be recorded.

  4. Pregnancy outcomes including implantation, clinical pregnancy, ongoing pregnancy, miscarriage and live birth will be followed up.

SVF, stromal vascular fraction.