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NCT Number: NCT06803199

Effects of LH and FSH 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.

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Key information

Conditions

Unrecognized Condition

Age range

35 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FSH and LH

Drug

In the study group, participants receive FSH and LH in IVF cycle

FSH

Drug

In the control group, participants receive FSH alone in IVF cycle

Primary outcomes

  1. oxygen consumption rate of mitochodria (%)

    Time frame: through study completion, an average of 3 year

    to assess mitocondrial function in cumulus cells

  2. Live birth rate (%)

    Time frame: through study completion, an average of 3 year

    a viable infant after 24 weeks of gestation

Secondary outcomes

  1. Amount of ATP production (moles/min) of mitochodria

    Time frame: through study completion, an average of 3 year

    to assess mitocondrial function in cumulus cells

  2. Clinical pregnancy rate (%)

    Time frame: through study completion, an average of 3 year

    the presence of a fetal heartbeat detected via transvaginal sonography at 6-7 weeks of gestation

Study contacts

Contact information is provided by the study sponsor or research team.

Li-Te Lin

CONTACT

[email protected]

+88673464027

Sponsors and collaborators

Lead sponsor

Kaohsiung Veterans General Hospital.

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jan 31, 2025
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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