The Effeciency of NMN in Improving IVF/ICSI-ET Pregnancy Outcomes in Patients With DOR

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-40
SponsorPeking University Third Hospital

About this trial

The purpose of the study is to understand the effect of nicotinamide mononucleotide (NMN) on patients with diminished ovarian reserve and the outcomes of IVF/ICSI-ET.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Individuals who are 20 to 40 years old.

The concentrations of anti-Mullerian hormone < 1.1 ng/ml,

the values of antral follicle count was less than 7

serum concentrations of day-3 follicle-stimulating hormone (FSH): 10 IU/L ≤ FSH<20 IU/L

Disqualifiers

Individuals who are during pregnant, lactation or menopause.

Individuals who had non-46-XX karyotype, or attributed to known genetic etiology.

Cancer patients or receiving chemo/radiotherapy treatment within the past 5 years.

Individuals who need regular medication to treat chronic diseases such as diabetes, hypertension, gout, hyperuricemia, etc.

Trial design

Design model

Parallel

Treatments tested in this trial

  • NMN

    Dietary supplement

    NMN capsules (total of 600mg/day) for 2-5 months

  • Placebo

    Other intervention

    NMN-free placebo capsules for 2-5 months

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: NMN interventionActive comparator 1 intervention
Group B: Placebo interventionPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

The clinical pregnancy rate

The pregnancy rate of IVF/ICSI-ET

Time frame
through study completion, an average of 2 year

Secondary outcomes

1

Endocrine hormones including AMH

Changes in endocrine hormones including AMH levels in serum after the intervention.

Time frame
Within three months after the end of treatment with NMN or placebo
2

Follicle number

The number of all antral follicles in each ovary will be determined using transvaginal ultrasonography for each participant.

Time frame
Within three months after the end of treatment with NMN or placebo
3

In vitro fertilization - outcome indicators of embryo culture

Number of oocytes obtained, number of MII oocytes, fertilization rate, number of available embryos, number of high-quality embryos, cycle cancellation rate

Time frame
Day of oocyte retrieval and 1 week after oocyte retrieval。Within three months after the end of treatment with NMN or placebo
4

Biochemical pregnancy rate

Biochemical pregnancy rate

Time frame
after pregnancy and infant borned. Within 1 year after the end of treatment with NMN or placebo

Other outcomes

Sponsors and contacts

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