NCT01267604

Trial name or title	Improving oocyte retrieval using a combined therapy of recombinant follicle‐stimulating hormone (rFSH) and inositol and melatonin
Methods	Randomised double‐blinded (participant, investigator) controlled trial.
Participants	Women 18 ‐ 39 years undergoing assisted reproductive techniques (ART) because of male infertility BMI 18 ‐ 30 kg/m2 Fewer than 3 prior oocyte retrievals No fertility problems
Interventions	Recombinant FSH: 225 IU rFSH Drug: recombinant FSH (rFSH) 225 IU Experimental: recombinant FSH inositol melatonin 225 IU rFSH, 4 g inositol and 3 mg melatonin dietary supplement: rFSH + inositol + melatonin 225 IU rFSH, 4 g inositol, 3 mg melatonin
Outcomes	Primary: total number of oocytes, number of clinical pregnancies, live birth rate
Starting date	December 2010
Contact information	Vittorio Unfer, MD +39 0640500835 vunfer@gmail.com Gianfranco Carlomagno, PhD gianfranco.carlomagno@gmail.com University of Modena and Reggio Emilia Recruiting Reggio Emilia, Italy, 42100  Contact: Giovanni Battista La Sala, MD     +39 0522 296464     giovanni.lasala@asmn.re.it      Principal investigator: Giovanni Battista La Sala, MD              Research Center for Reproductive Medicine Villa Mafalda Recruiting Roma, Italy, 00199
Notes	May not become an included study because all women are fertile, but they have subfertile male partners ClinicalTrials.gov Identifier: NCT01267604. Recruiting. Trial found on clinicaltrials.gov on 7th August 2012