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

December 22, 2016 updated by: Andros Day Surgery Clinic

Age Versus Ovarian Reserve Markers Based Therapy in IN Vitro Fertilization

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

194

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Sicily
      • Palermo, Sicily, Italy, 90144
        • ANDROS Day Surgery Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A: "age"
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: buserelin
Drug: rFSH
Experimental: Group B: "nomogram"
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: buserelin
Drug: rFSH

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The percentage of women with an appropriate number (N=8-14) of retrieved oocytes in IVF/ICSI cycles
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andros Day Surgery Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

March 20, 2013

First Submitted That Met QC Criteria

March 21, 2013

First Posted (Estimate)

March 22, 2013

Study Record Updates

Last Update Posted (Estimate)

December 23, 2016

Last Update Submitted That Met QC Criteria

December 22, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANDROS-01-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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