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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| endometrial injury | Experimental | Endometrial injury during ovarian stimulation combined with intrauterine insemination. |
|
| no endometrial injury | Active Comparator | Ovarian stimulation combined with intrauterine insemination. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endometrial injury. | Procedure | Endometrial injury using a pipelle biopsy catheter on day (5, 6 or 7) of the stimulation cycle combined with the intrauterine insemination. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Chemical Pregnancy Rate | Human chorionic gonadotrophin (b-hcg) detection in serum two weeks after intrauterine insemination. | two weeks after intrauterine insemination |
| Clinical Pregnancy Rate | Ultrasound detection of an intrauterine positive fetal heart pulsations | six weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed Bahaa | Lecturer in Obstetrics and Gynecology, faculty of medicine, Ain Shams University. | Principal Investigator |
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11 patients were excluded because they did not show up for their appointments in assisted reproductive technology unit.
Patients were recruited from the infertility clinic and given appointments to go to the Assisted Reproductive Technology unit to start the process of IUI.
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| ID | Title | Description |
|---|---|---|
| FG000 | Endometrial Injury | Endometrial injury during ovarian stimulation cycle 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 clomiphene citrate 100mg orally (from cycle day 2 for 5 days) and human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm. |
| FG001 | 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 clomiphene citrate 100mg orally (from cycle day 2 for 5 days) and human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Chemical Pregnancy Rate | Human chorionic gonadotrophin (b-hcg) detection in serum two weeks after intrauterine insemination. | Posted | Number | participants | two weeks after intrauterine insemination |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ahmed Bahaa | Ain Shams Maternity Hospital | +20 1111700556 | abahaa0503@yahoo.com |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D007315 | Insemination, Artificial |
| D010062 | Ovulation Induction |
| ID | Term |
|---|---|
| D027724 | Reproductive Techniques, Assisted |
| D012099 | Reproductive Techniques |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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|
| intrauterine insemination | Procedure | Placement of washed sperm in the uterus using a catheter, around the time of ovulation. |
|
|
| ovarian stimulation | Drug | Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm. |
|
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
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. |
|
|
| Primary | Clinical Pregnancy Rate | Ultrasound detection of an intrauterine positive fetal heart pulsations | Posted | Number | participants | six weeks |
|
|
|
| 0 |
| 162 |
| 0 |
| 162 |
| EG001 | 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. | 0 | 167 | 0 | 167 |
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| D007314 | Insemination |
| D012098 | Reproduction |
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |