In Vitro Fertilization Clinical Trial
Official title:
Age Versus Ovarian Reserve Markers Based Therapy in IN Vitro Fertilization
Verified date | October 2016 |
Source | Andros Day Surgery Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: National Institute of Health |
Study type | Interventional |
This randomized controlled trial has been designed for carrying out a comparison of new AMH (Anti-Müllerian Hormone)-based individualized treatment (using a nomogram) with the wide accepted age-based strategy. The main objective of the trial is to assess whether an individualized FSH starting dose can increase the rate of women with an adequate ovarian response in terms of retrieved oocytes (optimal number of retrieved oocytes: 8-14).
Status | Terminated |
Enrollment | 194 |
Est. completion date | July 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - first or second IVF/ICSI attempt (the second one after 6 months from the first one);regular menstrual cycles (25-33 days);female age = 40; day 3 FSH = 15IU/L;treatment with a long GnRH agonist protocol (buserelin)+rFSH;BMI: >18 and = 25 kg/m2;presence of both ovaries. Exclusion Criteria: - irregular cycles, anovulatory infertility, endometriosis III-IV stage AFS, use of adjunctive therapies for stimulation, evidence of PCO status, previous ovarian surgery, presence of ovarian cysts, history of PID, use of hormonal contraception in the previous 3 months, any known metabolic or endocrinological disease, AMH levels < 1 and > 4.0 ng/ml |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | ANDROS Day Surgery Clinic | Palermo | Sicily |
Lead Sponsor | Collaborator |
---|---|
Andros Day Surgery Clinic |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The percentage of women with an appropriate number (N=8-14) of retrieved oocytes in IVF/ICSI cycles | 24 months | Yes |
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