Ovarian Stimulation: Inositol and Melatonin

AGUNCO Obstetrics and Gynecology Centre

Status and phase: Withdrawn; Phase 4

Conditions: Infertility

Treatments: Drug: Recombinant FSH (rFSH); Dietary Supplement: rFSH + Inositol + Melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT01267604

rFSH-INOPLUS

Details and patient eligibility

About

An efficient protocol of ovarian stimulation is a key part of assisted reproductive technology. In order to obtain the highest oocyte retrieval with no adverse effects, numerous studies have evaluated the efficiency of the clinical approaches currently available.

Recent studies have shown that two natural compounds, such as inositol and melatonin, play an important role in oocyte maturation and quality. Therefore, the present study aims at investigating whether inositol and melatonin are able to improve the number of oocytes obtained after ovarian stimulation with Recombinant Follicle Stimulating Hormone (rFSH).

To this purpose, a randomized double-blind trial will be established where 150 healthy women in reproductive age undergoing to assistant reproductive technology (ART) because of male infertility will be divided in two groups. Group A will be treated with 225IU rFSH alone, group B will be treated with 225IU rFSH, 4g inositol and 3mg melatonin.

As primary outcome of the study, oocyte quality, total number of oocytes retrieved, clinical pregnancy rate and live birth rate will be evaluated in group A vs. group B.

Sex: Female

Ages: 18 to 39 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Female age 18-39 years
• BMI 18-30 kg/m2,
• Fewer than 3 prior oocyte retrievals,
• No fertility Problems

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Recombinant FSH

Active Comparator group

Description:

225IU rFSH

Treatment:

Drug: Recombinant FSH (rFSH)

Recombinant FSH Inositol Melatonin

Experimental group

Description:

225IU rFSH, 4g Inositol and 3mg Melatonin

Treatment:

Dietary Supplement: rFSH + Inositol + Melatonin