Effect of Ovarian Stimulation With r-hLH/r-hFSH,r-hFSH and hMG in Reducing Apoptosis Rate in Cumulus Cells of Patients Undergoing ICSI

NCT01872247 | Completed

• 1 other identifier: apoptosis2013
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

HP-hMG, recombinant FSH (r-hFSH) and a combination of r-hFSH/r-hLH, are commonly used for ovarian stimulation in infertile women undergoing IVF/ICSI treatments. Several publications have compared the effectiveness of these compounds, in terms of clinical outcomes. The aim of our study is to investigate the effects of three different ovarian stimulation protocols (HP-hMG, r-hFSH and r-hFSH/r-hLH), in a pilot prospective observational study, evaluating the effects of recombinant LH and extractive hCG (with LH like activity) on the biological outcome as well as on the clinical outcome. We will use the apoptosis rate of the cumulus cell, usually discarded after oocyte collection, as molecular biomarker to assess the oocyte quality, as biological outcome. The clinical outcome was estimated measuring implantation and ongoing pregnancy rates within and between the three different ovarian stimulation protocols

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• apoptosis of cumulus cell

  The apoptosis of cumulus cells has been investigated by "in situ" fluorescent TUNEL assay. The measure of apoptosis is the percentage of apoptotic cells on the total of cells analyzed. Usually a rate less than 15% in considered normal

  1 year

Eligibility Criteria

• Age: 30 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Infertile women after 2 years of failed spontaneous conception

You may qualify if:

• normal basal level of FSH (\< 12 IU/mL)
• normal body mass index (BMI = kg/m2 \< 28)
• poor or hyporesponse in a previous cycle according to Bologna criteria

You may not qualify if:

• Azoospermia
• Endometriosis
• recurrent abortion
• recurrent failures after IVF

Sponsors & Collaborators

• Centro di Biologia della Riproduzione, Palermo, Italy: lead

Study Sites (1)

Centro di Biologia della Riproduzione

Palermo, 90141, Italy

Location

Related Publications (2)

• Carone D, Caropreso C, Vitti A, Chiappetta R. Efficacy of different gonadotropin combinations to support ovulation induction in WHO type I anovulation infertility: clinical evidences of human recombinant FSH/human recombinant LH in a 2:1 ratio and highly purified human menopausal gonadotropin stimulation protocols. J Endocrinol Invest. 2012 Dec;35(11):996-1002. doi: 10.3275/8657. Epub 2012 Oct 22.

  PMID: 23095369 BACKGROUND

• Ruvolo G, Bosco L, Pane A, Morici G, Cittadini E, Roccheri MC. Lower apoptosis rate in human cumulus cells after administration of recombinant luteinizing hormone to women undergoing ovarian stimulation for in vitro fertilization procedures. Fertil Steril. 2007 Mar;87(3):542-6. doi: 10.1016/j.fertnstert.2006.06.059. Epub 2006 Nov 27.

  PMID: 17126339 RESULT

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Giovanni Ruvolo, Biologist

  Centro di Biologia della Riproduzione, Palermo, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2013
• First Posted: June 7, 2013
• Study Start: January 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 7, 2013

Record last verified: 2013-05

Locations

IT (1)