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

NCT01816789 | Terminated Phase 4

• 1 other identifier: ANDROS-01-13
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

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).

Conditions

In Vitro Fertilization; Ovarian Stimulation

Keywords

Starting dose; rFSH; controlled; ovarian; stimulation; IVF/ICSI; cycles

Outcome Measures

Primary Outcomes (1)

• The percentage of women with an appropriate number (N=8-14) of retrieved oocytes in IVF/ICSI cycles

  24 months

Study Arms (2)

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.

Drug: rFSH; Drug: buserelin

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.

Drug: rFSH; Drug: buserelin

Interventions

rFSH DRUG

Group A: "age"; Group B: "nomogram"

buserelin DRUG

Group A: "age"; Group B: "nomogram"

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Andros Day Surgery Clinic: lead

Study Sites (1)

ANDROS Day Surgery Clinic

Palermo, Sicily, 90144, Italy

Location

MeSH Terms

Interventions

Buserelin

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2013
• First Posted: March 22, 2013
• Study Start: March 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: December 23, 2016

Record last verified: 2016-10

Locations

IT (1)