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

Sponsor
Andros Day Surgery Clinic (Other)
Overall Status
Terminated
CT.gov ID
NCT01816789
Collaborator
(none)
194
1
2
40
4.8

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
194 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Age Versus Ovarian Reserve Markers Based Therapy in IN Vitro Fertilization
Study Start Date :
Mar 1, 2013
Actual Primary Completion Date :
Jul 1, 2016
Actual Study Completion Date :
Jul 1, 2016

Arms and Interventions

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: rFSH

Drug: buserelin

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: rFSH

Drug: buserelin

Outcome Measures

Primary Outcome Measures

  1. The percentage of women with an appropriate number (N=8-14) of retrieved oocytes in IVF/ICSI cycles [24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 ANDROS Day Surgery Clinic Palermo Sicily Italy 90144

Sponsors and Collaborators

  • Andros Day Surgery Clinic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Andros Day Surgery Clinic
ClinicalTrials.gov Identifier:
NCT01816789
Other Study ID Numbers:
  • ANDROS-01-13
First Posted:
Mar 22, 2013
Last Update Posted:
Dec 23, 2016
Last Verified:
Oct 1, 2016
Keywords provided by Andros Day Surgery Clinic
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 23, 2016