In Vitro Fertilization, Ovarian Stimulation
Conditions
Keywords
Starting dose, rFSH, controlled, ovarian, stimulation, IVF/ICSI, cycles
Brief summary
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).
Detailed description
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: 1. Serum E2 levels on r-hCG day 2. Serum P levels on r-hCG day 3. Number of growing follicles (≥11mm) on r-hCG day 4. Number of large (≥ 17 mm) ovarian follicles on r-hCG day 5. Total r-FSH dose employed 6. Treatment duration 7. Rate of women with dose adjustment 8. Number of cancelled cycles because of poor and hyper-response 9. Fertilization rate 10. Embryos obtained 11. Implantation rates 12. Biochemical pregnancy rates 13. Clinical pregnancy rates 14. OHSS rates
Sponsors
Andros Day Surgery Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of women with an appropriate number (N=8-14) of retrieved oocytes in IVF/ICSI cycles | 24 months |
Countries
Italy
Outcome results
None listed