HCG Injection for Infertility

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Fertility Center of Las Vegas

Must not be taking: Lovenox

Disqualifiers: Minors, Two embryos, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

220 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the use of a hormone injection called hCG to determine its effectiveness in improving the success of thawed embryo transfers for women facing infertility. Participants are divided into two groups: one receives the hCG injection, and the other does not. The study seeks women planning a thawed embryo transfer with at least one frozen embryo of good quality. Those with a history of embryo transfers or using donor eggs or sperm may also qualify. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand how it can benefit more patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for this treatment?

Research has shown that hCG (human chorionic gonadotropin) is generally safe and well-tolerated in infertility treatments. Studies indicate its effectiveness and safety are comparable to other treatments, with no significant differences in outcomes like live births. Thus, hCG does not add extra risks compared to other infertility treatments.

Since hCG is used in various medical treatments and is in the final research stage (Phase 4), strong evidence supports its safety for people. By this stage, a treatment is usually proven safe for many individuals. Therefore, participating in a trial with hCG is expected to present minimal safety concerns. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the hCG injection for infertility because it offers a direct approach to stimulate ovulation. Unlike other treatments that might involve oral medications like Clomiphene Citrate or Letrozole, hCG mimics the natural hormone LH (luteinizing hormone), which directly triggers the release of an egg. This targeted action could potentially lead to more timely and predictable ovulation, potentially increasing the chances of conception. Additionally, hCG is administered as a single injection, which might be more convenient and less burdensome compared to daily pills or complex treatment regimens.

What evidence suggests that hCG might be an effective treatment for infertility?

This trial will compare the effects of hCG (human chorionic gonadotropin) on infertility. Participants in the hCG Group will receive one injection of hCG. Research has shown that hCG can help treat infertility. In one study, 57.7% of women who received hCG became pregnant, compared to 49% in the group that did not receive it. Another study found that using hCG increased pregnancy success rates by 26%. For men, hCG treatment significantly increased sperm counts, improving their chances of fathering a child. Overall, hCG has shown positive results in boosting fertility for both men and women. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adult women planning to have a thawed embryo transfer, with at least one high-quality frozen blastocyst and one antral follicle. It's open to those using genetic testing, donor materials, or gestational carriers. Women can participate after failed transfers but not if they've had a successful pregnancy past ten weeks in the study.

Inclusion Criteria

At least one available frozen blastocyst of transferrable quality

I am a woman planning to have a thawed embryo transferred to me.

I am a woman not in menopause and have at least one antral follicle.

Exclusion Criteria

I am under 18 years old.

Use of embryo(s) frozen at another center

Patient for whom the physician assesses this protocol is inappropriate or unsafe

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either an injection of hCG or no hCG during the thawed embryo transfer process

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment, including blood pressure measurement in the third trimester of pregnancy

Third trimester of pregnancy

What Are the Treatments Tested in This Trial?

Interventions

• HCG

Trial Overview The study is examining whether injecting hCG (a hormone) affects the success of transferring thawed embryos into the uterus. Participants are randomly chosen to either receive an hCG injection or no intervention before their embryo transfer procedure.

How Is the Trial Designed?

Group I: hCG Group Experimental Treatment 1 Intervention

This group receives one injection of hCG.

Group II: No hCG Group Active Control 1 Intervention

This arm receives no hCG.

Who Is Running the Clinical Trial?

Fertility Center of Las Vegas

Lead Sponsor

Trials

6

Recruited

550+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11689596/

Efficacy of uterine flushing with human chorionic ... The results showed that intrauterine hCG increased the pregnancy success rate by 26% in the intervention group, whereas the fertility rate in ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666334125000509

Efficacy of human chorionic gonadotropin hormone in ... The mean TSC increased significantly from 18.0 million to 146.9 million after hCG treatment and TMSC increased from 1.1 million at baseline to 66.9 million ...

3. cureus.com cureus.com/articles/304922-use-of-human-chorionic-gonadotropin-hcg-or-hcg-combined-treatments-in-male-infertility-a-systematic-review

Use of Human Chorionic Gonadotropin (HCG) or ... Current evidence suggests that HCG therapy can be effective for the treatment of infertility disorders such as varicocele or hypogonadism.

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/andr.70003

Human chorionic gonadotropin‐based clinical treatments ... We examine the evidence regarding the effectiveness of human chorionic gonadotropin in treating infertility in men with pre-testicular or ...

5. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2020.592921/full

Effect of Human Chorionic Gonadotropin Injection Before ... Results: There was a significant increase in clinical pregnancy rate in the hCG group (57.7 vs. 49%, p = 0.027) compared with the control group.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9184418/

Effectiveness and safety of gonadotropins used in female ... Overall, 15.8% of cycles successfully led to pregnancy. Compared to extractives, recombinant and combined treatments showed a stronger association with ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S001502821200283X

Efficacy and safety of human chorionic gonadotropin for ... In relation to the final outcome (i.e., live births), hCG and control treatments were similar, with an RR of 1.42 (95% CI, 0.97–2.08). The clinical pregnancy ...

8. asrm.org asrm.org/practice-guidance/practice-committee-documents/use-of-exogenous-gonadotropins-for-ovulation-induction-in-anovulatory-women-a-committee-opinion-2020/

Use of exogenous gonadotropins for ovulation induction in ... A small study of women with hypothalamic amenorrhea demonstrated pregnancy rates of 25% per cycle (36). The type of gonadotropin did not appear to have ...