The Effect of Melatonin Supplementation on Cumulus Cells and IVF Outcomes

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age35-45
SponsorKaohsiung Veterans General Hospital.

About this trial

This study investigates the effects of melatonin supplementation on cumulus cell gene expression and in vitro fertilization (IVF) outcomes in women over 35 years old. In the study group, patients will receive melatonin supplementation for at least two months prior to their IVF cycles. Cumulus cells will be collected after oocyte retrieval, and IVF outcomes will be assessed.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 35-45 years

BMI 18-30 kg/m2

planning to undergo IVF cycles

Disqualifiers

Primary ovarian insufficiency

history of oophorectomy

receiving oocyte donation

Chromosome anomaly

Trial design

Design model

Parallel

Treatments tested in this trial

  • Melatonin

    Dietary supplement

    In the study group, patients will receive melatonin supplementation for at least two months prior to IVF cycles

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Melatonin groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Live birth rate (%)

a viable infant after 24 weeks of gestation

Time frame
through study completion, an average of 4 year
2

oxygen consumption rate of mitochodria (%)

to assess mitocondrial function in cumulus cells

Time frame
through study completion, an average of 4 year
3

mRNA levels of cumulus cell genes

to assess cumulus cells gene expression analysis

Time frame
through study completion, an average of 4 year

Secondary outcomes

1

Clinical pregnancy rate (%)

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

Time frame
through study completion, an average of 4 year
2

Ongoing pregnancy rate (%)

the continuation of the pregnancy beyond 12 weeks of gestation

Time frame
through study completion, an average of 4 year
3

Amount of ATP production (moles/min) of mitochodria

to assess mitocondrial function in cumulus cells

Time frame
through study completion, an average of 4 year

Other outcomes

Sponsors and contacts

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