Infertility
Conditions
Brief summary
Study Hypothesis: There is a difference in pregnancy rates between intrauterine insemination (IUI) in cycles performed with cervical occlusion by a balloon catheter designed for sonohysterograms as compared to those performed with a standard inseminator. The investigators will compare pregnancy rates in patients undergoing routine IUI either with balloon occlusion or with standard insemination. The patients will receive the standard clinical care per the investigators' office guidelines, except they will be randomized to insemination with either of two catheters.
Detailed description
An open speculum will be used and patients will undergo insemination with their partners sperm (same quantity in both arms). If randomized to treatment arm a balloon catheter will be filled with 1cc of air prior to insemination. The speculum will be removed immediately and the catheter will be left in for 15 minutes and then removed. Pregnancy outcomes will be recorded in both groups.
Interventions
PROCEDUREIntrauterine Insemination
The intervention arm will undergo temporary (15 minutes) cervical occlusion with the eliptosphere intracervical catheter. This catheter is typically used to perform saline infusion ultrasounds to image the uterine cavity in our practice.
PROCEDUREIUI with the standard inseminator
The control arm will undergo insemination with the standard inseminator (TOmcat catheter).
Sponsors
Women and Infants Hospital of Rhode Island
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* All patients undergoing IUI for unexplained infertility in our office: Center for Reproduction and Infertility (Providence, RI)
Exclusion criteria
* Abnormal Semenalysis TMC \< 5 million * Blocked Fallopian tubes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Pregnancy | 1 month | positive beta HCG test |
Secondary
| Measure | Time frame |
|---|---|
| Live Birth | 9 months |
| Positive Pregnancy Test | 14 days |
Countries
United States
Participant flow
Recruitment details
All patients recruited were women scheduled previously for IUI for treatment of unexplained infertility at the WIHRI office.
Pre-assignment details
2 patients in the occlusion group experienced pain and were immediately transferrred to the standard group,thereby creating an apparent discrepancy in numbers
Participants by arm
| Arm | Count |
|---|---|
| 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) | 40 |
| Standard IUI Insemination with TOmcat catheter | 55 |
| Total | 95 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
Baseline characteristics
| Characteristic | Cervical Occulsion | Standard IUI | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants | 55 Participants | 95 Participants |
| Region of Enrollment United States | 40 participants | 55 participants | 95 participants |
| Sex: Female, Male Female | 40 Participants | 55 Participants | 95 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 | 2 / 40 | 0 / 55 |
| serious Total, serious adverse events | 0 / 40 | 0 / 55 |
Outcome results
Primary
Clinical Pregnancy
positive beta HCG test
Time frame: 1 month
Population: All study women undergoing IUI were included
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cervical Occulsion | Clinical Pregnancy | 1 positive pregnancy test (beta HCG) |
| Standard IUI | Clinical Pregnancy | 7 positive pregnancy test (beta HCG) |
Secondary
Live Birth
Time frame: 9 months
Secondary
Positive Pregnancy Test
Time frame: 14 days