NCT01267604

Ovarian Stimulation: Inositol and Melatonin

Improving Oocyte Retrieval Using a Combined Therapy of Recombinant Follicle Stimulating Hormone (rFSH) and Inositol and Melatonin

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: AGUNCO Obstetrics and Gynecology Centre · Academic / Other
• Sex: Female
• Age: 18 Years – 39 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Infertility

Interventions

Type	Name	Description
DRUG	Recombinant FSH (rFSH)	225IU
DIETARY_SUPPLEMENT	rFSH + Inositol + Melatonin	225IU rFSH, 4g Inositol, 3mg Melatonin

Timeline

• Start date: 2010-12-01
• Primary completion: 2013-12-01
• First posted: 2010-12-28
• Last updated: 2023-07-20

Locations

2 sites across 1 country: Italy