Ovarian Stimulation: Inositol and Melatonin
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|ClinicalTrials.gov Identifier: NCT01267604|
Recruitment Status : Unknown
Verified December 2010 by AGUNCO Obstetrics and Gynecology Centre.
Recruitment status was: Recruiting
First Posted : December 28, 2010
Last Update Posted : December 28, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Drug: Recombinant FSH (rFSH) Dietary Supplement: rFSH + Inositol + Melatonin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Improving Oocyte Retrieval Using a Combined Therapy of Recombinant Follicle Stimulating Hormone (rFSH) and Inositol and Melatonin|
|Study Start Date :||December 2010|
Active Comparator: Recombinant FSH
Drug: Recombinant FSH (rFSH)
Experimental: Recombinant FSH Inositol Melatonin
225IU rFSH, 4g Inositol and 3mg Melatonin
Dietary Supplement: rFSH + Inositol + Melatonin
225IU rFSH, 4g Inositol, 3mg Melatonin
- Total oocyte number [ Time Frame: 2 weeks after pharmacological treatment ]
- Number of clinical pregnancies [ Time Frame: 6 weeks after embryo transfer ]
- Live birth rate [ Time Frame: 10 months after embryo transfer ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01267604
|Contact: Vittorio Unfer, MD||+39 firstname.lastname@example.org|
|Contact: Gianfranco Carlomagno, PhDemail@example.com|
|University of Modena and Reggio Emilia||Recruiting|
|Reggio Emilia, Italy, 42100|
|Contact: Giovanni Battista La Sala, MD +39 0522 296464 firstname.lastname@example.org|
|Principal Investigator: Giovanni Battista La Sala, MD|
|Research Center for Reproductive Medicine Villa Mafalda||Recruiting|
|Roma, Italy, 00199|
|Contact: Franco Lisi, MD +39 06 86094776 email@example.com|
|Principal Investigator: Franco Lisi, MD|
|Study Director:||Vittorio Unfer, MD||AGUNCO Obstetrics and Gynecology Centre|
|Principal Investigator:||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|