Infertility Clinical Trial
Official title:
A Pilot Study on the Effect of Ovarian Stimulation With r-hLH/r-hFSH, r-hFSH and hMG in Reducing Apoptosis Rate in Cumulus Cells of Patients Undergoing ICSI
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
Status | Completed |
Enrollment | 61 |
Est. completion date | June 2013 |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 30 Years to 45 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - Azoospermia - Endometriosis - recurrent abortion - recurrent failures after IVF |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Italy | Centro di Biologia della Riproduzione | Palermo |
Lead Sponsor | Collaborator |
---|---|
Centro di Biologia della Riproduzione, Palermo, Italy |
Italy,
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. — View Citation
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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
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