Ovarian Stimulation: Inositol and Melatonin

Infertility Clinical Trial

Official title:

Improving Oocyte Retrieval Using a Combined Therapy of Recombinant Follicle Stimulating Hormone (rFSH) and Inositol and Melatonin

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01267604
• Other study ID #: rFSH-INOPLUS
• Status: Withdrawn
• Phase: Phase 4
• Start date: December 2010

Study information

• Verified date: July 2023
• Source: AGUNCO Obstetrics and Gynecology Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

• Female age 18-39 years

• BMI 18-30 kg/m2,

• Fewer than 3 prior oocyte retrievals,

• No fertility Problems

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Recombinant FSH (rFSH)
225IU

Dietary Supplement:
• rFSH + Inositol + Melatonin
225IU rFSH, 4g Inositol, 3mg Melatonin

Locations

Country	Name	City	State
Italy	University of Modena and Reggio Emilia	Reggio Emilia
Italy	Research Center for Reproductive Medicine Villa Mafalda	Roma

Sponsors (3)

Lead Sponsor	Collaborator
AGUNCO Obstetrics and Gynecology Centre	Research Center for Reproductive Medicine Villa Mafalda, University of Modena and Reggio Emilia

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total oocyte number		2 weeks after pharmacological treatment
Primary	Number of clinical pregnancies		6 weeks after embryo transfer
Primary	Live birth rate		10 months after embryo transfer