Trial Outcomes & Findings for HSG and Tubal Patency Study (NCT NCT02146248)

NCT ID: NCT02146248

Last Updated: 2017-03-22

Results Overview

Assessment of patency at follicular phase exam

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 11 participants
• Primary outcome timeframe: follicular phase HSG
• Results posted on: 2017-03-22

Participant Flow

14 subjects were screened, and 11 signed consent and enrolled. One dropped out prior to the first HSG, and10 completed the 2 natural cycle HSG, 9 completed the COC HSG, 7 the DMPA HSG, and one a final post DMPA HSG after restarting COCs

Participant milestones

Measure	HSG Studies Women will be given combined oral contraceptives and Depo-medroxyprogesterone acetate (DepoProvera®). 2 HSG studies will be done prior to hormonal treatment, 1 after the pill treatment, and depending on whether the tubes appear patent, 1 more after the depoProvera treatment, and a final HSG after another 2 weeks on the pill. Combined oral contraceptive: combined oral contraceptive pill will be dosed continuously for 30 days without cycle interruption DepoProvera: injectable hormonal contraceptive
Overall Study STARTED	11
Overall Study Enrolled	11
Overall Study Uterine Sounding	11
Overall Study HSG 1	10
Overall Study HSG 2	10
Overall Study HSG 3	9
Overall Study HSG 4	7
Overall Study HSG 5	1
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure

HSG Studies Women will be given combined oral contraceptives and Depo-medroxyprogesterone acetate (DepoProvera®). 2 HSG studies will be done prior to hormonal treatment, 1 after the pill treatment, and depending on whether the tubes appear patent, 1 more after the depoProvera treatment, and a final HSG after another 2 weeks on the pill. Combined oral contraceptive: combined oral contraceptive pill will be dosed continuously for 30 days without cycle interruption DepoProvera: injectable hormonal contraceptive

Overall Study Withdrawal by Subject

2

Baseline Characteristics

HSG and Tubal Patency Study

Baseline characteristics by cohort

Measure	HSG Studies n=11 Participants Women will be given combined oral contraceptives and Depo-medroxyprogesterone acetate (DepoProvera®). 2 HSG studies will be done prior to hormonal treatment, 1 after the pill treatment, and depending on whether the tubes appear patent, 1 more after the depoProvera treatment, and a final HSG after another 2 weeks on the pill. Combined oral contraceptive: combined oral contraceptive pill will be dosed continuously for 30 days without cycle interruption DepoProvera: injectable hormonal contraceptive
Age, Continuous	34 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	11 Participants n=5 Participants
Nulligravid	6 Participants n=5 Participants
One or more births	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: follicular phase HSG

Assessment of patency at follicular phase exam

Outcome measures

Measure	Follicular Phase HSG n=10 Participants
Number of Participants With Bilateral Tubal Patency as Assessed by HSG-follicular bilateral patent	9 Participants
Number of Participants With Bilateral Tubal Patency as Assessed by HSG-follicular blocked	1 Participants

PRIMARY outcome

Timeframe: luteal phase HSG

Assessment of patency at luteal phase exam

Outcome measures

Measure	Follicular Phase HSG n=10 Participants
Number of Participants With Bilateral Tubal Patency as Assessed by HSG - Luteal bilateral tubal patency	10 Participants
Number of Participants With Bilateral Tubal Patency as Assessed by HSG - Luteal blocked	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: HSG on OC

HSG during OC treatment

Outcome measures

Measure	Follicular Phase HSG n=9 Participants
Number of Participants With Bilateral Tubal Patency as Assessed by HSG - OC HSG bilateral tubal patency	7 Participants
Number of Participants With Bilateral Tubal Patency as Assessed by HSG - OC HSG blocked	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: HSG on DMPA

HSG during DMPA treatment

Outcome measures

Measure	Follicular Phase HSG n=7 Participants
Number of Participants With Bilateral Tubal Patency as Assessed by HSG - DMPA HSG bilateral patubal patency	6 Participants
Number of Participants With Bilateral Tubal Patency as Assessed by HSG - DMPA HSG blocked	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: HSG on OC after DMPA

Outcome measures

Measure	Follicular Phase HSG n=1 Participants
Number of Participants With Bilateral Tubal Patency as Assessed by HSG -- Post DMPA Add Back COC HSG bilateral patent	1 Participants
Number of Participants With Bilateral Tubal Patency as Assessed by HSG -- Post DMPA Add Back COC HSG blocked	0 Participants

Adverse Events

HSG Studies

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure

HSG Studies n=10 participants at risk Women will be given combined oral contraceptives and Depo-medroxyprogesterone acetate (DepoProvera®). 2 HSG studies will be done prior to hormonal treatment, 1 after the pill treatment, and depending on whether the tubes appear patent, 1 more after the depoProvera treatment, and a final HSG after another 2 weeks on the pill. Combined oral contraceptive: combined oral contraceptive pill will be dosed continuously for 30 days without cycle interruption DepoProvera: injectable hormonal contraceptive

Reproductive system and breast disorders Pelvic Pain

10.0% 1/10 • Number of events 1 • May 2014 - Feb 2015

Additional Information

Jeffrey T. Jensen

OHSU

Phone: 503-629-4058

Email: jensenje@ohsu.edu

Results disclosure agreements

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