Infertility, FemaleNCT04852029
Prospective Assessment of Impact of Personalized Dosing of Low-dose Human Chorionic Gonadotropin (hCG) on in Vitro Fertilization (IVF) Outcomes
A study testing Low dose hCG in people with Infertility, Female, run by Reproductive Medicine Associates of New Jersey at 1 site in United States.
Trial summary
The purpose of the study is to determine the effect of tailoring dosage of low-dose hCG secondary to serum hCG levels during IVF ovarian stimulation on sustained implantation rates of preimplantation genetically tested euploid embryos. Read more about this study
- Who is it for?
- Ages 18 to 46 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Low dose hCG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 46 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients whose physicians plan to prescribe low-dose hCG for ovarian stimulation
- Age 18-46
- Negative serum hCG prior to start of COH
- BMI >18 and <35
- Plan for ejaculated sperm use
- Plan for PGT testing with euploid embryo transfer
Who cannot join
- Administration of low-dose hCG during frozen embryo transfer cycle
- Concomitant Menopur administration during ovarian stimulation or during frozen embryo transfer cycle
- BMI <18 or >35
- Age <18 or >46
- Presence of hydrosalpinxes that communicate with the endometrial cavity
- Diagnosis of endometrial insufficiency: prior cycle with maximal endometrial thickness ≤ 6mm, abnormal endometrial pattern (failure to attain a trilaminar appearance), and persistent endometrial fluid
Show all 12Show fewer
- Uncorrected uterine factor infertility (uterine anomaly, submucosal myomas, uterine septum)
- Male partner with <100,000 total motile spermatozoa per ejaculate (donor sperm is acceptable)
- Use of surgical procedures to obtain sperm
- Couples undergoing IVF for fertility preservation with no immediate plan for subsequent FET (embryo banking)
- Personal history of repeated pregnancy loss (two or more unexplained clinical losses defined by presence of fetal heartbeat)
- Declination of PGT testing
Trial locations and contacts
1 site in 1 country.
United States1 site
Reproductive Medicine Associates of New Jersey
Basking Ridge, New Jersey, 07920
About this study
The purpose of the study is to determine the effect of tailoring dosage of low-dose hCG secondary to serum hCG levels during IVF ovarian stimulation on sustained implantation rates of preimplantation genetically tested euploid embryos.
Read the detailed description
The objective of this study is to conduct a double-blind prospective randomized control trial to determine if individualized hCG titration based on a patient's serum hCG level above or below the predetermined serum hCG level improves IVF outcomes, primarily sustained implantation rates. Patients who fall below the desired serum hCG threshold will be randomized to either maintaining their current dose of low dose hCG or being increased.
- Conditions
- Infertility, Female
- Being tested
- Low dose hCG
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose hCGOther
Patients will either maintain the current dose of have an increased dose prescribed based on randomization
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | to remain on current dose of low dose hCG Receives: Other: Low dose hCG |
| Intervention Group | Experimental | increased dose of low dose hCG prescribed Receives: Other: Low dose hCG |
What is being measured
The primary outcome is the main question the study is designed to answer.
sustained implantation rate
presence of fetal heart beat upon discharge
Measured: 8 weeks gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start16 Aug 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Why it stopped: recruitment issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reproductive Medicine Associates of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04852029
- Sponsor's protocol ID
- RMA-2021-01
- Status last verified
- Jan 2022
- First submitted
- 15 Apr 2021
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Assessment of Impact of Personalized Dosing of Low-dose Human Chorionic Gonadotropin (hCG) on in Vitro Fertilization (IVF) Outcomes
- ClinicalTrials.gov ID
- NCT04852029
- Acronym / sponsor ID
- RMA-2021-01
- Conditions
- Infertility, Female
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment issues
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Reproductive Medicine Associates of New JerseyUniversity, hospital or other
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 21 Apr 2021 (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.
The purpose of the study is to determine the effect of tailoring dosage of low-dose hCG secondary to serum hCG levels during IVF ovarian stimulation on sustained implantation rates of preimplantation genetically tested euploid embryos.
Detailed description
The objective of this study is to conduct a double-blind prospective randomized control trial to determine if individualized hCG titration based on a patient's serum hCG level above or below the predetermined serum hCG level improves IVF outcomes, primarily sustained implantation rates. Patients who fall below the desired serum hCG threshold will be randomized to either maintaining their current dose of low dose hCG or being increased.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Low dose hCGto remain on current dose of low dose hCG |
| Intervention Group | Experimental | Other: Low dose hCGincreased dose of low dose hCG prescribed |
Who may qualify
- Ages
- 18 to 46 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients whose physicians plan to prescribe low-dose hCG for ovarian stimulation
- Age 18-46
- Negative serum hCG prior to start of COH
- BMI >18 and <35
- Plan for ejaculated sperm use
Key exclusion criteria (12 listed)
- Administration of low-dose hCG during frozen embryo transfer cycle
- Concomitant Menopur administration during ovarian stimulation or during frozen embryo transfer cycle
- BMI <18 or >35
- Age <18 or >46
- Presence of hydrosalpinxes that communicate with the endometrial cavity
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 |
|---|---|---|
| Low dose hCGPatients will either maintain the current dose of have an increased dose prescribed based on randomization | Other | Control Group, Intervention Group |
Primary outcome
sustained implantation rate
Time frame: 8 weeks gestational age
presence of fetal heart beat upon discharge
Results and safety
The study was stopped early (reason given: recruitment issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low dose hCG in people with Infertility, Female, run by Reproductive Medicine Associates of New Jersey 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 6 inclusion and 12 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: stopped early, as of the sponsor's last update on 28 Jan 2022. 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.
Are results available for this study?
The study was stopped early (reason given: recruitment issues). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sustained implantation rate (time frame: 8 weeks gestational age). 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 28 Jan 2022.