Infertility
Conditions
Brief summary
The investigator suggests that local endometrial injury using pipelle catheter performed in the follicular phase (cycle day 5, 6 or 7) of the stimulation cycle may improve the pregnancy rates among patients undergoing intrauterine insemination.
Detailed description
In a selected group of patients with repeated implantation failure, endometrial injury in the preceding cycle may improve ICSI outcome. Little is known about the efficacy of this procedure in improving intrauterine insemination outcome. Also little is known about the effect of this procedure if done in the stimulation cycle weather in ICSI or intrauterine insemination cycles.
Interventions
PROCEDUREendometrial injury.
Endometrial injury using a pipelle biopsy catheter on day (5, 6 or 7) of the stimulation cycle combined with the intrauterine insemination.
PROCEDUREintrauterine insemination
Placement of washed sperm in the uterus using a catheter, around the time of ovulation.
DRUGovarian stimulation
Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm.
Sponsors
Ain Shams Maternity Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 38 Years
Healthy volunteers
No
Inclusion criteria
* 18 - 38 years. * patent fallopian tunes. * mild male factor. * anovulation. * unexplained infertility.
Exclusion criteria
* indications for ICSI. * evidence of pelvic inflammatory disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chemical Pregnancy Rate | two weeks after intrauterine insemination | Human chorionic gonadotrophin (b-hcg) detection in serum two weeks after intrauterine insemination. |
| Clinical Pregnancy Rate | six weeks | Ultrasound detection of an intrauterine positive fetal heart pulsations |
Participant flow
Recruitment details
Patients were recruited from the infertility clinic and given appointments to go to the Assisted Reproductive Technology unit to start the process of IUI.
Pre-assignment details
11 patients were excluded because they did not show up for their appointments in assisted reproductive technology unit.
Participants by arm
| Arm | Count |
|---|---|
| Endometrial Injury Endometrial injury during ovarian stimulation combined with intrauterine insemination.
endometrial injury.: Endometrial injury using a pipelle biopsy catheter on day (5, 6 or 7) of the stimulation cycle combined with the intrauterine insemination.
intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.
ovarian stimulation: Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm. | 162 |
| no Endometrial Injury Ovarian stimulation combined with intrauterine insemination.
intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.
ovarian stimulation: Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm. | 167 |
| Total | 329 |
Baseline characteristics
| Characteristic | Endometrial Injury | no Endometrial Injury | Total |
|---|---|---|---|
| Age, Continuous | 28.57 years STANDARD_DEVIATION 3.99 | 29.52 years STANDARD_DEVIATION 4.09 | 29.1 years STANDARD_DEVIATION 4.1 |
| BMI | 28.5 kg/m^2 STANDARD_DEVIATION 4 | 29.35 kg/m^2 STANDARD_DEVIATION 3.02 | 28.9 kg/m^2 STANDARD_DEVIATION 3.6 |
| Region of Enrollment Egypt | 162 participants | 167 participants | 329 participants |
| Sex: Female, Male Female | 162 Participants | 167 Participants | 329 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 162 | 0 / 167 |
| serious Total, serious adverse events | 0 / 162 | 0 / 167 |
Outcome results
Primary
Chemical Pregnancy Rate
Human chorionic gonadotrophin (b-hcg) detection in serum two weeks after intrauterine insemination.
Time frame: two weeks after intrauterine insemination
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Endometrial Injury | Chemical Pregnancy Rate | 40 participants |
| no Endometrial Injury | Chemical Pregnancy Rate | 19 participants |
Primary
Clinical Pregnancy Rate
Ultrasound detection of an intrauterine positive fetal heart pulsations
Time frame: six weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Endometrial Injury | Clinical Pregnancy Rate | 32 participants |
| no Endometrial Injury | Clinical Pregnancy Rate | 13 participants |