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

In Vitro Fertilization Clinical Trial

Official title:

Age Versus Ovarian Reserve Markers Based Therapy in IN Vitro Fertilization

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01816789
• Other study ID #: ANDROS-01-13
• Status: Terminated
• Phase: Phase 4
• First received: March 20, 2013
• Last updated: December 22, 2016
• Start date: March 2013
• Est. completion date: July 2016

Study information

• 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

Clinical Trial 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).

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

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• In Vitro Fertilization
• Ovarian Stimulation

Intervention

Drug:
• rFSH

• buserelin

Locations

Country	Name	City	State
Italy	ANDROS Day Surgery Clinic	Palermo	Sicily

Sponsors (1)

Lead Sponsor	Collaborator
Andros Day Surgery Clinic

Country where clinical trial is conducted

Italy, 

Outcome

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