Clinical trial NCT01267604: Ovarian Stimulation: Inositol and Melatonin
Official title: Improving Oocyte Retrieval Using a Combined Therapy of Recombinant Follicle Stimulating Hormone (rFSH) and Inositol and Melatonin
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Infertility
Lead sponsor: AGUNCO Obstetrics and Gynecology Centre
Sponsor class: OTHER
Collaborators: name: University of Modena and Reggio Emilia
name: Research Center for Reproductive Medicine Villa Mafalda
First posted: 2010-12-28
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Total oocyte number
timeFrame: 2 weeks after pharmacological treatment
measure: Number of clinical pregnancies
timeFrame: 6 weeks after embryo transfer
measure: Live birth rate
timeFrame: 10 months after embryo transfer
Secondary outcomes:
Other outcomes:
Locations:
city: Reggio Emilia
country: Italy
facility: University of Modena and Reggio Emilia
city: Roma
country: Italy
facility: Research Center for Reproductive Medicine Villa Mafalda
Study officials:
affiliation: AGUNCO Obstetrics and Gynecology Centre
name: Vittorio Unfer, MD
role: STUDY_DIRECTOR
affiliation: AGUNCO Obstetrics and Gynecology Centre
name: Gianfranco Carlomagno, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Modena and Reggio Emilia
name: La Sala Giovanni Battista, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Center for Reproductive Medicine
name: Franco Lisi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.