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Effects of LH and FSH on Metabolic Regulation in Cumulus Cells

NCT ID: NCT06803199

Last Updated: 2025-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2027-12-31

Brief Summary

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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

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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.

Conditions

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Unrecognized Condition

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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combined FSH and LH

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

Group Type EXPERIMENTAL

FSH and LH

Intervention Type DRUG

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

FSH alone

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

Group Type ACTIVE_COMPARATOR

FSH

Intervention Type DRUG

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

Interventions

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FSH and LH

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

Intervention Type DRUG

FSH

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kaohsiung Veterans General Hospital.

OTHER

Sponsor Role lead

Responsible Party

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Li-Te Lin

Attending doctor, Department of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kuan-Hao Tsui

Role: STUDY_CHAIR

Kaohsiung Veterans General Hospital.

Locations

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Kaohsiung Veterans General Hospital

Kaohsiung City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Li-Te Lin

Role: CONTACT

Phone: +88673464027

Email: [email protected]

Facility Contacts

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Li-Te Lin

Role: primary

Kuan-Hao Tsui

Role: backup

Other Identifiers

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KSVGH24-CT7-22

Identifier Type: -

Identifier Source: org_study_id