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Recruiting NCT06803199

Effects of LH and FSH on Metabolic Regulation in Cumulus Cells

No phase Interventional Unrecognized Condition

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: FSH and LH, FSH.
Who it may be relevant to
Registry conditions: Unrecognized Condition. Basic parameters: 35 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Investigation of the Combined Effects of Luteinizing Hormone and Follicle-Stimulating Hormone on Metabolic Regulation in Cumulus Cells

Overview

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.

Interventions

  • Drug FSH and LH
    In the study group, participants receive FSH and LH in IVF cycle
  • Drug FSH
    In the control group, participants receive FSH alone in IVF cycle

Primary outcome measures

  • oxygen consumption rate of mitochodria (%) [Time frame: through study completion, an average of 3 year]
  • Live birth rate (%) [Time frame: through study completion, an average of 3 year]
Secondary outcome measures (2)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • Kaohsiung Veterans General Hospital — Kaohsiung City

Identifiers

NCT: NCT06803199 · KSVGH24-CT7-22

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗