Effects of LH and FSH on Metabolic Regulation in Cumulus Cells

January 27, 2025 updated by: Li-Te Lin, Kaohsiung Veterans General Hospital.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Kaohsiung City, Taiwan, 81362
        • Recruiting
        • Kaohsiung Veterans General Hospital
        • Contact:
          • Kuan-Hao Tsui
          • Phone Number: +886-7-3422121
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: combined FSH and LH
Participants receive combined FSH and LH during controlled ovarian stimulation in IVF cycle
Drug: FSH and LH
In the study group, participants receive FSH and LH in IVF cycle
Active Comparator: FSH alone
Participants receive combined FSH and LH during controlled ovarian stimulation in IVF cycle
Drug: FSH
In the control group, participants receive FSH alone in IVF cycle

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 3 year
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
through study completion, an average of 3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Veterans General Hospital.

Investigators

  • Study Chair: Kuan-Hao Tsui, Kaohsiung Veterans General Hospital.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

January 27, 2025

First Submitted That Met QC Criteria

January 27, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 27, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • KSVGH24-CT7-22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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