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

Andros Day Surgery Clinic

Status and phase: Terminated; Phase 4

Conditions: In Vitro Fertilization; Ovarian Stimulation

Treatments: Drug: rFSH; Drug: buserelin

Study type: Interventional

Funder types: Other

Identifiers

NCT01816789

ANDROS-01-13

Details and patient eligibility

About

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).

Full 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

Enrollment: 194 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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194 participants in 2 patient groups

Group A: "age"

Active Comparator group

Description:

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.

Treatment:

Drug: rFSH

Drug: buserelin

Group B: "nomogram"

Experimental group

Description:

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.

Treatment:

Drug: rFSH

Drug: buserelin