Metformin XR to reduce hyperemesis gravidarum risk in people trying to conceive
Official title: Hyperemesis Gravidarum Risk Reduction With Metformin
Run by University of Southern California · NCT07129473 · Data updated 2026-11-12
This study tests whether daily extended-release metformin taken before and early in pregnancy can lower the chance and severity of hyperemesis gravidarum in people ages 18–49 who have had HG before and are trying to conceive.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 49 Years |
| Sex | Women only |
| Enrollment | 224 (estimated) |
| Sponsor | University of Southern California Academic / other |
| Locations | 2 sites (Birmingham, Alabama and 1 other locations) |
| Status | Recruiting |
| Started | July 13, 2026 |
| Main results expected | March 2031 |
| Study ends | March 2031 |
| Registry record updated | July 22, 2026 |
| Trial ID | NCT07129473 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults 18–49 with a history of HG requiring IV fluids in a prior pregnancy who are actively trying to conceive and meet study-specific health criteria.
✕Probably not a fit
Individuals who do not become pregnant during the trial or who do not tolerate metformin-XR may not experience benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional program combines Phase 1 and Phase 2 to assess safety, tolerability, and potential dosing of metformin extended-release in individuals who have had HG previously and are attempting pregnancy. Participants begin with a titration period to determine the highest tolerable dose, followed by maintenance dose through early pregnancy or up to 12 months if pregnancy does not occur. The study will monitor adverse events, kidney and blood parameters, and overall tolerability, while exploring which biological and clinical factors predict response. The investigation is conducted at USC Keck and The Morning Sickness & HG Clinic in Birmingham, Alabama, with geographic eligibility limited to California and Alabama for the treatment arm. The aim is to see if metformin-XR can reduce HG risk and identify responders.
Why it matters
Potential benefit: If successful, metformin-XR could reduce the risk and severity of HG for people planning pregnancy.
How similar studies have gone: Previous research in similar metabolic approaches has shown safety signals for metformin in pregnancy-related contexts, but this specific preconception, HG-focused approach is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ages 18-49 * HG in prior pregnancy (clinical criteria: intravenous (IV) fluid treatment) * Trying to conceive * Treatment Arm: willing to refrain from trying to conceive during their metformin dose titration period and before 2 weeks at maximum tolerated dose (up to 8 weeks total). Will use birth control or contraceptive device until maintenance dose. * Under care of a personal OB/GYN or willing to establish care with a personal OB/GYN before study start * Ownership of a personal scale (or willingness to obtain one for study use) * Willing to participate in a trial that includes daily use of an oral agent prior to pregnancy * Treatment Arm: residing in California/Alabama * Treatment Arm: normal blood panel (CBC) (e.g., white count, hemoglobin, platelets all within the normal range) * Treatment Arm: normal to mildly decreased creatinine levels (estimated GFR \> 60 mL/min/1.73m²) * Survey/Comparator Arm: not currently taking metformin and do not plan to take metformin prior to pregnancy * Able and willing to provide written informed consent prior to initiation of any study procedures. * Demonstrates understanding of the study objectives, requirements, potential risks, and willingness to comply with study procedures and follow-up. * English speaking * Regular cycles Exclusion Criteria: * Allergic or adverse reaction to metformin-XR * Thalassemia * Cirrhosis and/or hepatic impairment * Decompensated heart failure * Daily/regular use of medications/substances (tobacco, cyclobenzaprine, cannabis, escitalopram, sertraline, other SSRIs, Lasix) * Treatment Arm: Use of insulin, sulfonylureas, meglitinides, or other blood sugar altering medication * Assisted Reproductive Technology * Excess alcohol consumption (\> 7 standard drinks per week on average) * Pregnant * Not trying to conceive * Treatment Arm: Residing outside California/Alabama * Treatment Arm: abnormal blood panel (CBC) (e.g., white count or platelets not within the normal range) * Treatment Arm: abnormal creatinine levels (estimated GFR \< 60 mL/min/1.73m² excluded from the study, signs of kidney disease) * Treatment Arm: current metformin use * Survey/Comparator Arm: current metformin use or plans to take metformin prior to pregnancy * Any medical/surgical condition that the investigator feels would compromise the participant's participation in the study * Not able and willing to provide written informed consent prior to initiation of any study procedures. * Does not demonstrate understanding of the study objectives, requirements, potential risks, and willingness to comply with study procedures and follow-up. * Not english speaking * Irregular cycles * Not willing to refrain from trying to conceive/use birth control or contraceptive device until maintenance dose.
Where it's running
-
University of Southern California - Keck School of Medicine
Los Angeles, California, United States Recruiting -
The Morning Sickness & HG Clinic
Birmingham, Alabama, United States Not yet recruiting
Study contacts
- Principal investigator: Marlena Fejzo, PhD — University of Southern California
- Study coordinator: Marlena Fejzo, PhD
- Email: Marlena.Fejzo@med.usc.edu
- Phone: 310-383-3581
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Remote follow-up with a connected app after emergency gynecological care
This trial tests if using a secure connected health app for remote follow-up improves satisfaction and clinical outcomes for women aged 18–60 after emergency gynecological visits.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.