Clinical trial NCT01816789: Age Versus Ovarian Reserve Markers Based Therapy in IVF (IVF)/Intracytoplasmic Sperm Injection (ICSI) Cycles
Official title: Age Versus Ovarian Reserve Markers Based Therapy in IN Vitro Fertilization
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: In Vitro Fertilization
Ovarian Stimulation
Keywords: Starting dose
rFSH
controlled
ovarian
stimulation
IVF/ICSI
cycles
Lead sponsor: Andros Day Surgery Clinic
Sponsor class: OTHER
First posted: 2013-03-22
Enrollment: 194
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: The percentage of women with an appropriate number (N=8-14) of retrieved oocytes in IVF/ICSI cycles
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: ANDROS Day Surgery Clinic
state: Sicily
Study officials:
References: