An Early Phase 1 interventional study of Warmed HSG in Infertility, sponsored by University of Oklahoma. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by University of Oklahoma · Early Phase 1, Interventional, and Prevention
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Among 395 studies in Infertility with a site in United States — 63 open to participants now, 85 under way, 7 of them phase 3. Infertility · United States.
Among the 395 studies in Infertility with a site in United States, this one is the 63rd largest by planned enrollment of the 274 interventional ones that give a count, is one of 17 that started in 2026, is one of 14 in phase 1, reaches primary completion later than 25 of the 83 other live ones, and was the 381st registered.
2,088 studies on the registry are indexed under Infertility; 356 are open to participants now.
Browse Infertility studies →63 of the 395 studies in Infertility with a site in United States are open now. Recruiting first, the newest first:
Abigail Mancuso · Sites in United States
Ages 18–45
Brigham and Women's Hospital · Sites in United States
Ages 18–40 · Women only · Healthy volunteers
Kevin Doody · Sites in United States
Ages 18–35 · Women only
Reproductive Medicine Associates of New Jersey · Sites in United States
Ages 18–42 · Women only
Brigham and Women's Hospital · Sites in United States
Ages 18+ · Men only
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 234 Infertility studies recruiting now, 43 (18%) set no upper age limit and 185 (79%) stop at 75 or younger; 27 take children under 18; 76 take healthy volunteers.
This study: 18 Years to 45 Years · female · no healthy volunteers.
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395 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 19 · Phase 2 32 · Phase 3 31 · Phase 4 35
First in 1989; this study’s year is marked. 17 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 240 is above the median of 134 across 1,414 interventional studies indexed under Infertility.
Median enrollment 89 across the 274 interventional studies, 150 across the 119 observational. Of the 251 that completed or were terminated, 57 (23%) have results posted.
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91 of 395 have an industry lead sponsor. The 10 most frequent:
University of Oklahoma is the lead sponsor of 432 studies on the registry; 100 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.
University of Oklahoma has 2 studies filed under Infertility — fewer than ten, so there is no comparison to draw.
25 of the studies in Infertility with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06375811Phase 3Yale UniversityPre-IVF Treatment With a GnRH Antagonist in Women With endometriosis_temp | 2027-03-31 |
| NCT06858111Phase 3Gameto, Inc.Fertilo In Vitro Research Study and Trial | 2027-05 |
| NCT04544462Genomic Prediction Inc.ANXA5 M2 Haplotyping in IVF Patients and Embryos | 2026-11 |
| NCT07226310University of OklahomaThe Hysterosalpingogram (HSG) Experience And Tubal Spasm (HEAT) Study | 2026-12 |
| NCT07083700Inception Fertility Research Institute, LLCFrame Support Study | 2026-12 |
Add all 25 to your calendar (.ics) → With an account.
Among the 395 studies in Infertility with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The hysterosalpingogram (HSG) is the gold standard of assessing fallopian tube patency and involves the placement of a transcervical catheter to allow for instillation of radio-opaque dye into the uterine cavity and fallopian tubes which are then imaged with abdominal x-ray. A common side effect of the instillation of dye is the uterine cramping, which is both uncomfortable for the patient as well as can cause iatrogenic proximal occlusion of the fallopian tubes. Proximal tubal obstruction is often not representative of true tubal obstruction but is rather an artifact of the test. Prior studies measuring the perceived pain and cramping during HSG have been conducted which have shown reduced pain scores and decreased uterine cramping when warmed contrast dye is used. The researchers propose that the use of warmed contrast media during HSG will be correlated with decreased pain scores and fewer cases of proximal tubal occlusion in women with otherwise normal uterine anatomy.
Research materials will include obtaining patient past medical history at time of the patient screening and recruitment, via utilization of Epic to search for demographic factors including age, height, weight, BMI, race/ethnicity, duration of infertility, past medical history, and gynecologic/obstetric history.
Post-procedure images from the HSG/report of the HSG findings will be saved in Epic as per usual standard clinical practice. HSG findings will be transcribed with prior demographics/history into a PHI-safe RedCap. No biospecimens will be collected under this protocol.
Patients undergoing fertility treatment that are recommended to undergo HSG as part of their evaluation will be referred to a dedicated research nurse (RN) for eligibility screening and informed consent.
Once found to be meeting inclusion criteria, the patient will be consented and scheduled for HSG as appropriate for their menstrual cycle and clinical care. Typically, patients are scheduled during cycle day 5-10 of their menstrual cycle for best study image quality.
Once scheduled, the patient will be randomized to warmed (body temperature) vs cold (room temperature) HSG. The principal investigator will create a computer-generated randomization table (1:1) using block randomization with randomly varying block size of 4 and 6 without stratification.
Study team members will have electronic access to the table of randomization within the secure REDCap randomization module and will assign each patient to a single-blinded treatment group once informed consent is obtained.
HSG will be performed in accordance with clinic policy by a physician or physician assistant trained in the procedure and interpretation of study results. Patients will be asked to complete a pre- and post-procedure questionnaire.
All data will be collected by the research team and entered into RedCap. A single study visit lasting approximately 1 hour will be conducted. The patient will be assigned a unique study ID number, and the randomization module in REDCap will be used to assign the participant to either the experimental (warm) or control (cold) group.
The patient will be blinded to the treatment allocation, but the research team will be unblinded to allow for correct choice and use of warm versus cold contrast media. As research team members will touch the HSG contrast media and be able to discern if it is cold or warm, it is impossible to maintain blinding of the research team.
The control group (cold contrast) is the current standard of care and is included in this study as a control to allow for comparison with the experimental (warm contrast) group. All patients will obtain an HSG via the same standardized technique at OURM.
Patients may withdraw from the study at any time without repercussions and will be allowed to undergo HSG with standard of care practices at OURM at their discretion. Withdrawal of participation in the study will not change the course of a patient's fertility evaluation or treatment. If the study were to end prematurely, all patients will maintain scheduled appointments for HSG with standard practice methods (cold contrast dye) to be used as per clinic protocol.
All participant recruitment and data collection activities including consenting, interventions, chart reviews, and data analysis will occur at OU Reproductive Medicine clinic (OURM) and via Epic clinical chart review as needed to obtain study data. Data analysis will be conducted in the OUHSC Department of Biostatistics and Epidemiology using data exported from the HIPAA compliant REDCap database and stored on a secure server.
Patients and their fertility provider will all be informed of their HSG results after completion of the procedure as per clinic protocol as part of their fertility evaluation. Patients will be informed of their HSG results after completion of a post-procedure pain questionnaire.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1. Women ages 18-45 undergoing tubal assessment via HSG.
Exclusion Criteria:
HSG contrast will be standard, room-temperature
HSG constrast will be warmed.
Drug: Warmed HSG
The intervention is warming the HSG constrast.
Post-HSG Pain Questionnaire
To compare the patient experience for patients undergoing HSG when warm versus cold contrast media is utilized, patients will complete a post-HSG Questionnaire to indicate their level of pain.
Time frame: Measured 1 hour after HSG procedure
Rate of unilateral and bilateral proximal fallopian tube occlusion
The event proportions of unilateral and bilateral proximal fallopian tube occlusion at the time of HSG procedure will be compared between warms versus cold contrast media groups using chi-square tests or Fisher's exact tests as appropriate.
Time frame: Measured at the time of HSG procedure
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Dec 2026, 3 months later.
Of 27 phase 1 interventional studies under Infertility, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 38. This study's planned 3 months is below that.
How these figures are worked out, and which studies are left out of them.
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