Human Menopausal Gonadotropin for Infertility
(GRACE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a medication called Human Menopausal Gonadotropin (hMG) to determine if it aids women with infertility by developing multiple eggs, potentially leading to pregnancy and live birth. Participants will receive either the hMG treatment or a placebo (a harmless, inactive substance) through daily injections as part of an assisted reproductive technology (ART) cycle. Women with regular menstrual cycles and a valid reason for in vitro fertilization (IVF), aiming to become pregnant within a year, might be suitable for this study. As a Phase 3 trial, this study is the final step before potential FDA approval, offering participants a chance to contribute to a treatment that could soon become widely available.
Do I need to stop my current medications to join the trial?
The trial requires that you stop using certain medications, such as clomiphene citrate, metformin, gonadotropins, or GnRH analogs, at least one month before joining. Additionally, if you have been using bioidentical hormones, you need a three-month break before starting the trial. Some other medications, like non-steroidal anti-inflammatory drugs and certain psychotropic medications, may also need to be stopped.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Studies have shown that human menopausal gonadotropin (hMG) is generally safe for fertility treatments. Research indicates that hMG performs as well as other similar medications and is equally safe, causing no more side effects than other common fertility treatments. One study found that using hMG to assist with ovulation is as safe as treatments with FSH, another fertility hormone. Overall, these studies suggest that hMG is well-tolerated and does not lead to more negative side effects compared to other treatments.12345
Why do researchers think this study treatment might be promising?
Human Menopausal Gonadotropin (hMG) is unique because it directly stimulates the ovaries to produce eggs, using hormones extracted from the urine of postmenopausal women. Unlike common fertility treatments like Clomiphene Citrate, which indirectly influence the ovaries by affecting hormone levels, hMG contains the actual follicle-stimulating hormones needed for egg production. Researchers are excited because this could offer a more direct and potentially effective approach to treating infertility, especially for those who haven't had success with other methods.
What evidence suggests that human menopausal gonadotropin might be an effective treatment for infertility?
Research has shown that human menopausal gonadotropin (hMG), a treatment participants in this trial may receive, can aid infertility. One study found that combining hMG with intrauterine insemination (IUI) was more effective than IUI alone for conditions like endometriosis and male infertility. Another study reported that the likelihood of pregnancy with hMG ranged from 20% to 28% per woman treated. Additionally, the chance of maintaining a pregnancy with hMG was about 26.3% per treatment cycle. These findings suggest that hMG can enhance pregnancy chances for women undergoing fertility treatments.26789
Are You a Good Fit for This Trial?
This trial is for pre-menopausal women aged 18-42 with a BMI of ≥18 and <38, regular menstrual cycles (21-35 days), normal uterine cavity and ovaries, negative for certain infections, and have valid reasons for IVF treatment. Women over 40 need a normal mammogram. If using donor sperm, the donor must be 18-40 years old.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive daily subcutaneous injections of Human Menopausal Gonadotropin or placebo as part of an Assisted Reproductive Technology cycle
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of cumulative live birth rate
What Are the Treatments Tested in This Trial?
Interventions
- Human Menopausal Gonadotropin
Trial Overview
The study tests if hMG injections can improve the development of multiple follicles, pregnancy rates, and cumulative live births in women undergoing ART cycles compared to placebo. It's multicenter, randomized, double-blind meaning neither participants nor researchers know who gets what until after results are collected.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Human Menopausal Gonadotropin, daily subcutaneous injection
Placebo, daily subcutaneous injection
Find a Clinic Near You
Who Is Running the Clinical Trial?
Granata Bio Corporation
Lead Sponsor
Citations
A randomized and longitudinal study of human ...
Results: Human menopausal gonadotropin/IUI therapy was consistently more effective than IUI alone in the treatment of endometriosis, male factor infertility, ...
Effectiveness of human menopausal gonadotropin versus ...
Pregnancy outcome measures. Clinical pregnancy rates per woman ranged from 20% to 28% in all studies except both arms in the study of Westergaard et al.
Study Details | NCT07216742 | Human Menopausal ...
A Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of a Human Menopausal Gonadotropin in the ...
Retrospective analysis: The application of human ...
The live birth rate (19.9%) of the HMG combined with LE group were also significantly higher than those of the HMG group (11.2%, respectively).
Effectiveness of highly purified human menopausal ...
The ongoing pregnancy rates per started cycle were 26.3% and 25.2% for highly purified hMG and rFSH, respectively (no statistically significant difference).
Clinical efficacy and safety of two highly purified human ...
Researchers concluded that Gynogen HP works just as well as Menopur for IVF treatment and is equally safe to use. This means doctors can ...
Effectiveness of highly purified human menopausal ...
Ongoing pregnancy rates increased from 6% (95%CI 4.7–7.7) per natural cycle to 7.4% (95%CI 5.2–10.3) per highly purified hMG stimulated cycle (p = 0.34). The ...
Use of exogenous gonadotropins for ovulation induction in ...
A meta-analysis concluded that the outcomes of treatment achieved with human menopausal gonadotropins (hMG) and with FSH alone were similar (14).
Efficacy and safety of human menopausal gonadotrophins ...
As for the secondary outcomes, there was statistical significance with regard to the clinical pregnancy rate also in favour of the HMG group. Even so, there.
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