Trial Outcomes & Findings for Effect of Cervical Occlusion During Intrauterine Insemination (IUI) (NCT NCT00951171)

NCT ID: NCT00951171

Last Updated: 2012-08-28

Results Overview

positive beta HCG test

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 93 participants
• Primary outcome timeframe: 1 month
• Results posted on: 2012-08-28

Participant Flow

All patients recruited were women scheduled previously for IUI for treatment of unexplained infertility at the WIHRI office.

2 patients in the occlusion group experienced pain and were immediately transferrred to the standard group,thereby creating an apparent discrepancy in numbers

Participant milestones

Measure	Cervical Occulsion Insemination Eliptosphere catheter filled with 1cc of air for 15 minutes. H/S Eliptosphere by Copper surgical (U.S. Patent No. 5,624,399)	Standard IUI Insemination with TOmcat catheter
Overall Study STARTED	40	55
Overall Study Pregnancy	1	7
Overall Study COMPLETED	38	55
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	Cervical Occulsion Insemination Eliptosphere catheter filled with 1cc of air for 15 minutes. H/S Eliptosphere by Copper surgical (U.S. Patent No. 5,624,399)	Standard IUI Insemination with TOmcat catheter
Overall Study Adverse Event	2	0

Baseline Characteristics

Effect of Cervical Occlusion During Intrauterine Insemination (IUI)

Baseline characteristics by cohort

Measure	Cervical Occulsion n=40 Participants Insemination Eliptosphere catheter filled with 1cc of air for 15 minutes. H/S Eliptosphere by Copper surgical (U.S. Patent No. 5,624,399)	Standard IUI n=55 Participants Insemination with TOmcat catheter	Total n=95 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=5 Participants	55 Participants n=7 Participants	95 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	55 Participants n=7 Participants	95 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 United States	40 participants n=5 Participants	55 participants n=7 Participants	95 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month

Population: All study women undergoing IUI were included

positive beta HCG test

Outcome measures

Measure	Cervical Occulsion n=40 Participants Insemination Eliptosphere catheter filled with 1cc of air for 15 minutes. H/S Eliptosphere by Copper surgical (U.S. Patent No. 5,624,399)	Standard IUI n=53 Participants Insemination with TOmcat catheter
Clinical Pregnancy	1 positive pregnancy test (beta HCG)	7 positive pregnancy test (beta HCG)

SECONDARY outcome

Timeframe: 9 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 days

Outcome measures

Outcome data not reported

Adverse Events

Cervical Occulsion

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Standard IUI

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Cervical Occulsion n=40 participants at risk Insemination Eliptosphere catheter filled with 1cc of air for 15 minutes. H/S Eliptosphere by Copper surgical (U.S. Patent No. 5,624,399)	Standard IUI n=55 participants at risk Insemination with TOmcat catheter
Surgical and medical procedures pain with device	100.0% 2/2 • Number of events 2	— 0/0

Additional Information

Andrew S Blazar, MD Principal Investigator

WIHRI

Phone: 401-274-1122

Email: ablazar@WIHRI.org

Results disclosure agreements

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