Clinical trial NCT06803199: Effects of LH and FSH on Metabolic Regulation in Cumulus Cells
Official title: Investigation of the Combined Effects of Luteinizing Hormone and Follicle-Stimulating Hormone on Metabolic Regulation in Cumulus Cells
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Unrecognized Condition
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2025-01-31
Enrollment: 60
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Age 35-40 years
* BMI 18-30 kg/m2
* planning to undergo IVF cycles

Exclusion Criteria:

* 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

Primary outcomes:
measure: oxygen consumption rate of mitochodria (%)
timeFrame: through study completion, an average of 3 year
measure: Live birth rate (%)
timeFrame: through study completion, an average of 3 year
Secondary outcomes:
measure: Amount of ATP production (moles/min) of mitochodria
timeFrame: through study completion, an average of 3 year
measure: Clinical pregnancy rate (%)
timeFrame: through study completion, an average of 3 year
Other outcomes:
Locations:
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Veterans General Hospital
Study officials:
affiliation: Kaohsiung Veterans General Hospital.
name: Kuan-Hao Tsui
role: STUDY_CHAIR
References: