Trial Outcomes & Findings for Does Endometrial Injury Improve Intrauterine Insemination Outcome? (NCT NCT02542280)

NCT ID: NCT02542280

Last Updated: 2016-01-08

Results Overview

Human chorionic gonadotrophin (b-hcg) detection in serum two weeks after intrauterine insemination.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 360 participants
• Primary outcome timeframe: two weeks after intrauterine insemination
• Results posted on: 2016-01-08

Participant Flow

Patients were recruited from the infertility clinic and given appointments to go to the Assisted Reproductive Technology unit to start the process of IUI.

11 patients were excluded because they did not show up for their appointments in assisted reproductive technology unit.

Participant milestones

Measure	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.	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.
Overall Study STARTED	174	175
Overall Study COMPLETED	162	167
Overall Study NOT COMPLETED	12	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Does Endometrial Injury Improve Intrauterine Insemination Outcome?

Baseline characteristics by cohort

Measure	Endometrial Injury n=162 Participants 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.	no Endometrial Injury n=167 Participants 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.	Total n=329 Participants Total of all reporting groups
Age, Continuous	28.57 years STANDARD_DEVIATION 3.99 • n=5 Participants	29.52 years STANDARD_DEVIATION 4.09 • n=7 Participants	29.1 years STANDARD_DEVIATION 4.1 • n=5 Participants
Sex: Female, Male Female	162 Participants n=5 Participants	167 Participants n=7 Participants	329 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Egypt	162 participants n=5 Participants	167 participants n=7 Participants	329 participants n=5 Participants
BMI	28.5 kg/m^2 STANDARD_DEVIATION 4 • n=5 Participants	29.35 kg/m^2 STANDARD_DEVIATION 3.02 • n=7 Participants	28.9 kg/m^2 STANDARD_DEVIATION 3.6 • n=5 Participants

PRIMARY outcome

Timeframe: two weeks after intrauterine insemination

Human chorionic gonadotrophin (b-hcg) detection in serum two weeks after intrauterine insemination.

Outcome measures

Measure	Endometrial Injury n=162 Participants 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.	no Endometrial Injury n=167 Participants 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.
Chemical Pregnancy Rate	40 participants	19 participants

PRIMARY outcome

Timeframe: six weeks

Ultrasound detection of an intrauterine positive fetal heart pulsations

Outcome measures

Measure	Endometrial Injury n=162 Participants 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.	no Endometrial Injury n=167 Participants 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.
Clinical Pregnancy Rate	32 participants	13 participants

Adverse Events

Endometrial Injury

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

no Endometrial Injury

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ahmed Bahaa

Ain Shams Maternity Hospital

Phone: +20 1111700556

Email: abahaa0503@yahoo.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place