Trial | NCT01816789  Report issue

Title

Age Versus Ovarian Reserve Markers Based Therapy in IVF (IVF)/Intracytoplasmic Sperm Injection (ICSI) Cycles
Age Versus Ovarian Reserve Markers Based Therapy in IN Vitro Fertilization

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    194
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).
Before clinicians can adopt any model into routine clinical practice, the accuracy of the model should be independently evaluated in a population different from the one on which the model was elaborated. External validation of the model is therefore crucial to assess the generalizability to other populations.

In the present RCT the new AMH-based individualized treatment will be compared to the wide accepted age-based strategy.

Primary endpoint:

The percentage of women with an appropriate number (n=8-14) of retrieved oocytes in IVF/ICSI cycle.

Secondary endpoints:

Serum E2 levels on r-hCG day
Serum P levels on r-hCG day
Number of growing follicles (≥11mm) on r-hCG day
Number of large (≥ 17 mm) ovarian follicles on r-hCG day
Total r-FSH dose employed
Treatment duration
Rate of women with dose adjustment
Number of cancelled cycles because of poor and hyper-response
Fertilization rate
Embryos obtained
Implantation rates
Biochemical pregnancy rates
Clinical pregnancy rates
OHSS rates
Study Started
Mar 31
2013
Primary Completion
Jul 31
2016
Study Completion
Jul 31
2016
Last Update
Dec 23
2016
Estimate

Drug rFSH

Drug buserelin

Group A: "age" Active Comparator

Group A: long standard protocol (buserelin 0.1 ml s.c. twice per day from the 21st day of the cycle, until the end of gonadotropin administration) + 150 IU of rFSH (starting dose) if female age was ≤35 years or 225 IU of rFSH if female age was ≥ 36 years.

Group B: "nomogram" Experimental

Group B: long standard protocol (buserelin 0.1 ml s.c. twice per day from the 21st day of the cycle until the end of gonadotropin administration) + individualized starting dose of rFSH on the basis of the nomogram.

Criteria 

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
No Results Posted