Ovarian Stimulation: Inositol and Melatonin

Phase 4

Withdrawn

• Conditions: Infertility
• Interventions: Dietary Supplement: rFSH + Inositol + Melatonin; Drug: Recombinant FSH (rFSH)

• Registration Number: NCT01267604
• Lead Sponsor: AGUNCO Obstetrics and Gynecology Centre

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-23
• Study First Submitted QC: 2010-12-27
• Study First Posted: 2010-12-28
• Primary Completion: 2013-12
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-19
• Last Update Posted: 2023-07-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Recombinant FSH Inositol Melatonin	rFSH + Inositol + Melatonin	225IU rFSH, 4g Inositol and 3mg Melatonin
Recombinant FSH	Recombinant FSH (rFSH)	225IU rFSH

Primary Outcome Measures

Name	Time	Method
Total oocyte number	2 weeks after pharmacological treatment
Number of clinical pregnancies	6 weeks after embryo transfer
Live birth rate	10 months after embryo transfer

Trial Locations

Locations (2)

University of Modena and Reggio Emilia; 🇮🇹 Reggio Emilia, Italy

Research Center for Reproductive Medicine Villa Mafalda; 🇮🇹 Roma, Italy