| Methods |
Randomised controlled trial, 2 groups, set in Infertility Unit, Menoufia University Hospital, Shebin El‐Kom, Egypt
January 2015 to July 2016
Number of participants randomised: 110
Number of participants analysed: 105 |
| Participants |
Inclusion criteria:
≥ 1 year of infertility (primary, secondary) Aged 20 to 35 years Body mass index 19 to 30 kg/m² Day 2 serum follicle‐stimulating hormone (FSH) concentration < 12 IU/L Normal serum prolactin level (≤ 888 pmol/L) Normal thyroid function tests Normal uterine cavity on hysterosalpingography or hysteroscopy ≥ 1 patent tube with normal appearance on hysterosalpingography and/or laparoscopy Male partner with normal semen count and motility according to World Health Organization criteria No conception despite a good follicular response to clomiphene citrate for ≥ 3 cycles
Exclusion criteria:
Hypogonadotropic hypogonadism Diminished ovarian reserve (basal FSH > 12 IU/L) Anovulation after 150 mg clomiphene citrate for 3 cycles Infertility due to tubal or male factors Intrauterine organic pathology (myoma, polyp, adhesions) identified by hysterosalpingography or diagnostic hysteroscopy Women with previous in vitro fertilisation (IVF) or intrauterine insemination attempts
Cause of subfertility: unexplained |
| Interventions |
Intervention group: endometrial injury, using a pipelle catheter, in the luteal phase of the cycle preceding the ovarian stimulation cycle Control group: a sham procedure, which consisted of drying the cervix with gauze for 30 seconds, in the luteal phase of the cycle preceding the ovulation induction cycle
Both groups: ovulation induction was performed with clomiphene citrate starting on Day 3 to 5 for 5 days. When 1 or 2 follicles ≥ 18 mm were present, 10,000 IU human chorionic gonadotropin was used and couples were ask to have timed intercourse after 36 hours
Degree of endometrial injury: endosampler
Timing of endometrial injury: in the luteal phase (on Day 15 to 24) of a spontaneous menstrual cycle preceding the ovulation induction cycle
Study length: 1 cycle
Type of conception: timed intercourse |
| Outcomes |
Reported in the paper:
Clinical pregnancy (ultrasonograph evidence of ≥ 1 gestational sac at 6 weeks, or products of conception by histopathological examination) Ongoing pregnancy (≥ 1 foetal heart pulsation on ultrasonography beyond 20 weeks) Live birth (live birth of ≥ 1 neonate who lived ≥ 1 week after birth) Ectopic pregnancy (serum β‐hCG test > 1500 IU/L but no intrauterine gestational sac, or an adnexal mass seen on ultrasonography) Multiple pregnancy (≥ 2 gestational sacs seen at the same time at 6 weeks) Spontaneous abortion (no cardiac pulsation for a crown‐rump length corresponding to ≥ 6 weeks, no crown‐rump length in a gestational sac ≥ 25 mm, or pregnancy that ended before 20 weeks)
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| Notes |
Trial registration number: NCT02345837
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