Infertility
Conditions
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.
Interventions
225IU
DIETARY_SUPPLEMENTrFSH + Inositol + Melatonin
225IU rFSH, 4g Inositol, 3mg Melatonin
Sponsors
University of Modena and Reggio Emilia
Research Center for Reproductive Medicine Villa Mafalda
AGUNCO Obstetrics and Gynecology Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 39 Years
Healthy volunteers
Yes
Inclusion criteria
* Female age 18-39 years * BMI 18-30 kg/m2, * Fewer than 3 prior oocyte retrievals, * No fertility Problems
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Italy
Outcome results
None listed