Ovarian Stimulation: Inositol and Melatonin

NCT01267604 | Withdrawn Phase 4

• 1 other identifier: rFSH-INOPLUS
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Recombinant FSH

ACTIVE COMPARATOR

225IU rFSH

Drug: Recombinant FSH (rFSH)

Recombinant FSH Inositol Melatonin

EXPERIMENTAL

225IU rFSH, 4g Inositol and 3mg Melatonin

Dietary Supplement: rFSH + Inositol + Melatonin

Interventions

Recombinant FSH (rFSH) DRUG

225IU

Recombinant FSH

rFSH + Inositol + Melatonin DIETARY_SUPPLEMENT

225IU rFSH, 4g Inositol, 3mg Melatonin

Recombinant FSH Inositol Melatonin

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

Sponsors & Collaborators

• AGUNCO Obstetrics and Gynecology Centre: lead
• University of Modena and Reggio Emilia: collaborator
• Research Center for Reproductive Medicine Villa Mafalda: collaborator

Study Sites (2)

University of Modena and Reggio Emilia

Reggio Emilia, 42100, Italy

Location

Research Center for Reproductive Medicine Villa Mafalda

Roma, 00199, Italy

Location

Related Publications (3)

• Rizzo P, Raffone E, Benedetto V. Effect of the treatment with myo-inositol plus folic acid plus melatonin in comparison with a treatment with myo-inositol plus folic acid on oocyte quality and pregnancy outcome in IVF cycles. A prospective, clinical trial. Eur Rev Med Pharmacol Sci. 2010 Jun;14(6):555-61.

  PMID: 20712264 BACKGROUND

• Papaleo E, Unfer V, Baillargeon JP, Chiu TT. Contribution of myo-inositol to reproduction. Eur J Obstet Gynecol Reprod Biol. 2009 Dec;147(2):120-3. doi: 10.1016/j.ejogrb.2009.09.008. Epub 2009 Oct 2.

  PMID: 19800728 BACKGROUND

• Tamura H, Nakamura Y, Korkmaz A, Manchester LC, Tan DX, Sugino N, Reiter RJ. Melatonin and the ovary: physiological and pathophysiological implications. Fertil Steril. 2009 Jul;92(1):328-43. doi: 10.1016/j.fertnstert.2008.05.016. Epub 2008 Sep 18.

  PMID: 18804205 BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

Inositol; Melatonin

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Vittorio Unfer, MD

  AGUNCO Obstetrics and Gynecology Centre

  STUDY DIRECTOR

• Gianfranco Carlomagno, PhD

  AGUNCO Obstetrics and Gynecology Centre

  PRINCIPAL INVESTIGATOR

• La Sala Giovanni Battista, MD

  University of Modena and Reggio Emilia

  PRINCIPAL INVESTIGATOR

• Franco Lisi, MD

  Research Center for Reproductive Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2010
• First Posted: December 28, 2010
• Study Start: December 1, 2010
• Primary Completion: December 1, 2013
• Last Updated: July 20, 2023

Record last verified: 2023-07

Locations

IT (2)