Infertility (IVF Patients)Phase 4NCT07004192
The Role of hCG in Thawed Embryo Transfer
A Phase 4 study testing HCG injection in people with Infertility (IVF Patients), run by Fertility Center of Las Vegas at 1 site in United States.
Trial summary
This prospective randomized trial will assess the relevance, if any, of a corpus luteum induced by hCG in transfers of thawed embryos. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility (IVF Patients)
- What is being tested?
- HCG injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2025to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female adult expecting to receive transfer of a thawed embryo.
- At least one available frozen blastocyst of transferrable quality.
- Non-menopausal female with at least one antral follicle.
- Use of pre-implantation genetic testing (PGT), embryos derived from donor oocytes and/or donor sperm, a gestational carrier, and history of prior transfer(s) regardless of outcome are allowed.
- Subsequent embryo transfers after failed transfers under this study are allowed, but not after a transfer that has resulted in ongoing pregnancy at ten weeks gestation under this study.
Who cannot join
- Minors (age<18 years).
- Use of embryo(s) frozen at another center.
- Patient insistent on transfer of two embryos.
- Patient or partner unable to provide informed consent in English.
- Patient already enrolled in any other research study for her embryo transfer.
- History of anti-phospholipid syndrome or any other indication for use of Lovenox in pregnancy.
- Patient for whom the physician assesses this protocol is inappropriate or unsafe.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fertility Center of Las Vegas
Las Vegas, Nevada, 89113
Shironda Research Assistant, 702-254-1777 ext. 265, shironda@fertilitycenterlv.com
About this study
This prospective randomized trial will assess the relevance, if any, of a corpus luteum induced by hCG in transfers of thawed embryos.
Read the detailed description
The current study is designed to carefully isolate the effect of a corpus luteum by ensuring that the presence or absence of a corpus luteum is the only difference between two study arms. This should be reliably achieved by administering an injection of hCG in one study arm, while the other study arm has identical treatment except for omitting the hCG.
- Conditions
- Infertility (IVF Patients)
- Being tested
- HCG injection, No intervention
- Keywords
- Thawed embryo transfer
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCG injectionDrug
5000 IU hCG injection
No interventionOther
No hCG administered in this group.
| Study group | Role | What they receive |
|---|---|---|
| hCG Group | Experimental | This group receives one injection of hCG. Receives: Drug: HCG injection |
| No hCG Group | Active comparator | This arm receives no hCG. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Mean arterial pressure measured in third trimester of pregnancy
Measured: Third trimester of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start2 Jun 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility (IVF Patients)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fertility Center of Las Vegas
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Bruce Shapiro M.D., Fertility Center of Las Vegas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07004192
- Sponsor's protocol ID
- FCLV 2025-1
- Status last verified
- Jun 2025
- First submitted
- 27 May 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No current plan to do so in approved protocol.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of hCG in Thawed Embryo Transfer
- ClinicalTrials.gov ID
- NCT07004192
- Acronym / sponsor ID
- FCLV 2025-1
- Conditions
- Infertility (IVF Patients)
- Keywords
- Thawed embryo transfer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Fertility Center of Las VegasIndustry (pharma, biotech, devices)
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective randomized trial will assess the relevance, if any, of a corpus luteum induced by hCG in transfers of thawed embryos.
Detailed description
The current study is designed to carefully isolate the effect of a corpus luteum by ensuring that the presence or absence of a corpus luteum is the only difference between two study arms. This should be reliably achieved by administering an injection of hCG in one study arm, while the other study arm has identical treatment except for omitting the hCG.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hCG Group | Experimental | Drug: HCG injectionThis group receives one injection of hCG. |
| No hCG Group | Active comparator | Other: No interventionThis arm receives no hCG. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female adult expecting to receive transfer of a thawed embryo.
- At least one available frozen blastocyst of transferrable quality.
- Non-menopausal female with at least one antral follicle.
- Use of pre-implantation genetic testing (PGT), embryos derived from donor oocytes and/or donor sperm, a gestational carrier, and history of prior transfer(s) regardless of outcome are allowed.
- Subsequent embryo transfers after failed transfers under this study are allowed, but not after a transfer that has resulted in ongoing pregnancy at ten weeks gestation under this study.
Key exclusion criteria (7 listed)
- Minors (age<18 years).
- Use of embryo(s) frozen at another center.
- Patient insistent on transfer of two embryos.
- Patient or partner unable to provide informed consent in English.
- Patient already enrolled in any other research study for her embryo transfer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HCG injection5000 IU hCG injection | Drug | hCG Group |
| No interventionNo hCG administered in this group. | Other | No hCG Group |
Primary outcome
Blood pressure
Time frame: Third trimester of pregnancy
Mean arterial pressure measured in third trimester of pregnancy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: No. No current plan to do so in approved protocol.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing HCG injection in people with Infertility (IVF Patients), run by Fertility Center of Las Vegas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shironda Research Assistant (702-254-1777 ext. 265, shironda@fertilitycenterlv.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: Third trimester of pregnancy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.