Unrecognized ConditionNCT06803199
Effects of LH and FSH on Metabolic Regulation in Cumulus Cells
A study testing FSH and LH and FSH in people with Unrecognized Condition, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
Trial summary
The combined use of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) has improved IVF pregnancy rates in infertile women aged 35-40, but its mechanisms remain unclear. This prospective study will examine how FSH and LH combined treatment affects cumulus cell energy metabolism. Read more about this study
- Who is it for?
- Ages 35 to 40 years, women only
- Conditions the study is for
- Unrecognized Condition
- What is being tested?
- FSH and LH and FSH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2024to 31 Dec 2027
- Phase
- Interventional
- 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 35 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 35-40 years
- BMI 18-30 kg/m2
- planning to undergo IVF cycles
Who cannot join
- Primary ovarian insufficiency
- history of oophorectomy
- receiving oocyte donation
- Chromosome anomaly
- Congenital uterine anomaly
- Severe intrauterine adhesion
- Malignancy
- Using hormone therapy or supplements in recent 3 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Veterans General Hospital
Kaohsiung City, 81362
Li-Te Lin, +88673464027, litelin1982@gmail.com
Kuan-Hao Tsui, +886-7-3422121
About this study
Official title: Investigation of the Combined Effects of Luteinizing Hormone and Follicle-Stimulating Hormone on Metabolic Regulation in Cumulus Cells
The combined use of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) has improved IVF pregnancy rates in infertile women aged 35-40, but its mechanisms remain unclear. This prospective study will examine how FSH and LH combined treatment affects cumulus cell energy metabolism. Sixty participants will be divided into two groups receiving either combined therapy or FSH alone. The study will analyze patient characteristics, infertility history, and compare mitochondrial function in cumulus cells to evaluate treatment effectiveness.
Read the detailed description
The impact of combined follicle-stimulating hormone (FSH) and luteinizing hormone (LH) treatment on ovulation stimulation in older infertile women has garnered significant attention in reproductive medicine. While research indicates improved in vitro fertilization (IVF) pregnancy rates in women aged 35-40 receiving combined FSH and LH therapy compared to FSH alone, the underlying mechanisms and effectiveness remain unclear. This prospective study aims to investigate the effects of combined FSH and LH treatment on cumulus cell energy metabolism in infertile women aged 35-40 undergoing IVF treatment. The research will involve 60 participants divided into two equal groups: one receiving combined FSH and LH therapy and the other receiving FSH alone. The study will collect comprehensive data including baseline characteristics, infertility history, ovarian function parameters, and ovulation stimulation cycle outcomes. Additionally, cumulus cells will be collected from both groups to compare their mitochondrial metabolic function. Through this investigation, we seek to understand whether the combined hormone approach can enhance cumulus cell energy metabolism and improve overall ovulation stimulation outcomes in this specific age group. CopyRetryClaude can make mistakes. Please double-check responses.
- Conditions
- Unrecognized Condition
- Being tested
- FSH and LH, FSH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FSH and LHDrug
In the study group, participants receive FSH and LH in IVF cycle
FSHDrug
In the control group, participants receive FSH alone in IVF cycle
| Study group | Role | What they receive |
|---|---|---|
| combined FSH and LH | Experimental | Participants receive combined FSH and LH during controlled ovarian stimulation in IVF cycle Receives: Drug: FSH and LH |
| FSH alone | Active comparator | Participants receive combined FSH and LH during controlled ovarian stimulation in IVF cycle Receives: Drug: FSH |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxygen consumption rate of mitochodria (%)
to assess mitocondrial function in cumulus cells
Measured: through study completion, an average of 3 year
Live birth rate (%)
a viable infant after 24 weeks of gestation
Measured: through study completion, an average of 3 year
Secondary outcomes (2)
Amount of ATP production (moles/min) of mitochodria
to assess mitocondrial function in cumulus cells
Measured: through study completion, an average of 3 year
Clinical pregnancy rate (%)
the presence of a fetal heartbeat detected via transvaginal sonography at 6-7 weeks of gestation
Measured: through study completion, an average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start1 Dec 2024
- Primary completion31 Dec 2026 (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 Unrecognized ConditionStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Veterans General Hospital.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li-Te Lin, Kaohsiung Veterans General Hospital.
- Investigators
- Kuan-Hao Tsui, Study chair, Kaohsiung Veterans General Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06803199
- Sponsor's protocol ID
- KSVGH24-CT7-22
- Status last verified
- Jan 2025
- First submitted
- 27 Jan 2025
- Last updated
- 31 Jan 2025
- Results posted
- 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 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Combined Effects of Luteinizing Hormone and Follicle-Stimulating Hormone on Metabolic Regulation in Cumulus Cells
- ClinicalTrials.gov ID
- NCT06803199
- Acronym / sponsor ID
- KSVGH24-CT7-22
- Conditions
- Unrecognized Condition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kaohsiung Veterans General Hospital.University, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 31 Jan 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.
The combined use of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) has improved IVF pregnancy rates in infertile women aged 35-40, but its mechanisms remain unclear. This prospective study will examine how FSH and LH combined treatment affects cumulus cell energy metabolism. Sixty participants will be divided into two groups receiving either combined therapy or FSH alone. The study will analyze patient characteristics, infertility history, and compare mitochondrial function in cumulus cells to evaluate treatment effectiveness.
Detailed description
The impact of combined follicle-stimulating hormone (FSH) and luteinizing hormone (LH) treatment on ovulation stimulation in older infertile women has garnered significant attention in reproductive medicine. While research indicates improved in vitro fertilization (IVF) pregnancy rates in women aged 35-40 receiving combined FSH and LH therapy compared to FSH alone, the underlying mechanisms and effectiveness remain unclear. This prospective study aims to investigate the effects of combined FSH and LH treatment on cumulus cell energy metabolism in infertile women aged 35-40 undergoing IVF treatment. The research will involve 60 participants divided into two equal groups: one receiving combined FSH and LH therapy and the other receiving FSH alone. The study will collect comprehensive data including baseline characteristics, infertility history, ovarian function parameters, and ovulation stimulation cycle outcomes. Additionally, cumulus cells will be collected from both groups to compare their mitochondrial metabolic function. Through this investigation, we seek to understand whether the combined hormone approach can enhance cumulus cell energy metabolism and improve overall ovulation stimulation outcomes in this specific age group. CopyRetryClaude can make mistakes. Please double-check responses.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combined FSH and LH | Experimental | Drug: FSH and LHParticipants receive combined FSH and LH during controlled ovarian stimulation in IVF cycle |
| FSH alone | Active comparator | Drug: FSHParticipants receive combined FSH and LH during controlled ovarian stimulation in IVF cycle |
Who may qualify
- Ages
- 35 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 35-40 years
- BMI 18-30 kg/m2
- planning to undergo IVF cycles
Key exclusion criteria (8 listed)
- Primary ovarian insufficiency
- history of oophorectomy
- receiving oocyte donation
- Chromosome anomaly
- Congenital uterine anomaly
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 |
|---|---|---|
| FSH and LHIn the study group, participants receive FSH and LH in IVF cycle | Drug | combined FSH and LH |
| FSHIn the control group, participants receive FSH alone in IVF cycle | Drug | FSH alone |
Primary outcome
oxygen consumption rate of mitochodria (%)
Time frame: through study completion, an average of 3 year
to assess mitocondrial function in cumulus cells
Live birth rate (%)
Time frame: through study completion, an average of 3 year
a viable infant after 24 weeks of gestation
2 secondary outcomes
Amount of ATP production (moles/min) of mitochodria
Time frame: through study completion, an average of 3 year
Clinical pregnancy rate (%)
Time frame: through study completion, an average of 3 year
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 31 Jan 2025.
- 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.
Kuan-Hao Tsui study chair
Kaohsiung Veterans General Hospital.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FSH and LH and FSH in people with Unrecognized Condition, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
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 3 inclusion and 8 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 31 Jan 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 Taiwan. 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?
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 Li-Te Lin (+88673464027, litelin1982@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oxygen consumption rate of mitochodria (%) (time frame: through study completion, an average of 3 year). The study lists 2 primary outcomes in all. 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 31 Jan 2025.