Trial Outcomes & Findings for Endometrial Injury Versus Luteal Phase Support in Intrauterine Insemination Cycles (NCT NCT02492451)
NCT ID: NCT02492451
Last Updated: 2016-10-20
Results Overview
ongoing pregnancy rates
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
118 participants
Primary outcome timeframe
12 weeks
Results posted on
2016-10-20
Participant Flow
Participant milestones
| Measure |
Endometrial Injury
Endometrial injury in luteal phase of preceding IUI cycle
Endometrial Injury: Endometrial injury in luteal phase of preceding cycle by pipelle canula
|
Luteal Phase Support
Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.
progesterone (Crinone® %8 vaginal progesterone gel): Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.
|
Control Group
Only intrauterine insemination
|
|---|---|---|---|
|
Overall Study
STARTED
|
40
|
39
|
39
|
|
Overall Study
COMPLETED
|
40
|
39
|
39
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Endometrial Injury Versus Luteal Phase Support in Intrauterine Insemination Cycles
Baseline characteristics by cohort
| Measure |
Endometrial Injury
n=40 Participants
Endometrial injury in luteal phase of preceding IUI cycle
Endometrial Injury: Endometrial injury in luteal phase of preceding cycle by pipelle canula
|
Luteal Phase Support
n=39 Participants
Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.
progesterone (Crinone® %8 vaginal progesterone gel): Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.
|
Control Group
n=39 Participants
Only intrauterine insemination
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
27.85 years
STANDARD_DEVIATION 5.45 • n=5 Participants
|
28.13 years
STANDARD_DEVIATION 4.41 • n=7 Participants
|
29.95 years
STANDARD_DEVIATION 5.44 • n=5 Participants
|
28.64 years
STANDARD_DEVIATION 5.17 • n=4 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
118 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 weeksongoing pregnancy rates
Outcome measures
| Measure |
Endometrial Injury
n=40 Participants
Endometrial injury in luteal phase of preceding IUI cycle
Endometrial Injury: Endometrial injury in luteal phase of preceding cycle by pipelle canula
|
Luteal Phase Support
n=39 Participants
Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.
progesterone (Crinone® %8 vaginal progesterone gel): Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.
|
Control Group
n=39 Participants
Only intrauterine insemination
|
|---|---|---|---|
|
Pregnancy Rate
|
7.5 percentage of ongoing pregnancies
|
17.9 percentage of ongoing pregnancies
|
5.1 percentage of ongoing pregnancies
|
Adverse Events
Endometrial Injury
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Luteal Phase Support
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
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
Selcuk Selcuk
Zeynep Kamil Research and Teaching Hospital
Phone: +905321630488
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place