Effects of LH and FSH on Metabolic Regulation in Cumulus Cells

Not Applicable

Recruiting

• Conditions: Unrecognized Condition
• Interventions: Drug: FSH and LH; Drug: FSH

• Registration Number: NCT06803199
• Lead Sponsor: Kaohsiung Veterans General Hospital.

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.

Study Timeline

• Study Start: 2024-12-01
• Status Verified: 2025-01
• Study First Submitted: 2025-01-27
• Study First Submitted QC: 2025-01-27
• Last Update Submitted: 2025-01-27
• Study First Posted: 2025-01-31
• Last Update Posted: 2025-01-31
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
combined FSH and LH	FSH and LH	Participants receive combined FSH and LH during controlled ovarian stimulation in IVF cycle
FSH alone	FSH	Participants receive combined FSH and LH during controlled ovarian stimulation in IVF cycle

Primary Outcome Measures

Name	Time	Method
oxygen consumption rate of mitochodria (%)	through study completion, an average of 3 year	to assess mitocondrial function in cumulus cells
Live birth rate (%)	through study completion, an average of 3 year	a viable infant after 24 weeks of gestation

Secondary Outcome Measures

Name	Time	Method
Amount of ATP production (moles/min) of mitochodria	through study completion, an average of 3 year	to assess mitocondrial function in cumulus cells
Clinical pregnancy rate (%)	through study completion, an average of 3 year	the presence of a fetal heartbeat detected via transvaginal sonography at 6-7 weeks of gestation

Trial Locations

Locations (1)

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung City, Taiwan