NCT06803199

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
21mo left

Started Dec 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress46%
Dec 2024Dec 2027

Study Start

First participant enrolled

December 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 31, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

January 31, 2025

Status Verified

January 1, 2025

Enrollment Period

2.1 years

First QC Date

January 27, 2025

Last Update Submit

January 27, 2025

Conditions

Unrecognized Condition

Outcome Measures

Primary Outcomes (2)

  • oxygen consumption rate of mitochodria (%)

    to assess mitocondrial function in cumulus cells

    through study completion, an average of 3 year

  • Live birth rate (%)

    a viable infant after 24 weeks of gestation

    through study completion, an average of 3 year

Secondary Outcomes (2)

  • Amount of ATP production (moles/min) of mitochodria

    through study completion, an average of 3 year

  • Clinical pregnancy rate (%)

    through study completion, an average of 3 year

Study Arms (2)

combined FSH and LH

EXPERIMENTAL

Participants receive combined FSH and LH during controlled ovarian stimulation in IVF cycle

Drug: FSH and LH

FSH alone

ACTIVE COMPARATOR

Participants receive combined FSH and LH during controlled ovarian stimulation in IVF cycle

Drug: FSH

Interventions

FSH and LHDRUG

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

combined FSH and LH
FSHDRUG

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

FSH alone

Eligibility Criteria

Age35 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsInfertile women planning to undergo IVF cycles
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, 81362, Taiwan

RECRUITING

MeSH Terms

Interventions

Gonadotropin-Releasing Hormone

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Kuan-Hao Tsui

    Kaohsiung Veterans General Hospital.

    STUDY CHAIR

Central Study Contacts

Li-Te Lin

CONTACT

+88673464027litelin1982@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending doctor, Department of Obstetrics and Gynecology

Study Record Dates

First Submitted

January 27, 2025

First Posted

January 31, 2025

Study Start

December 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

January 31, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)