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

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ClinicalTrials.gov Identifier: NCT01816789
Recruitment Status : Terminated (Optimal response: 63% nomogram, 42% controls, overcoming the stopping rule for interim analysis)
First Posted : March 22, 2013
Last Update Posted : December 23, 2016
Sponsor:
Information provided by (Responsible Party):
Andros Day Surgery Clinic

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
In Vitro Fertilization Ovarian Stimulation Drug: rFSH Drug: buserelin 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

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Study Type : Interventional  (Clinical Trial)
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 : March 2013
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


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



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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01816789


Locations
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Italy
ANDROS Day Surgery Clinic
Palermo, Sicily, Italy, 90144
Sponsors and Collaborators
Andros Day Surgery Clinic
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Responsible Party: Andros Day Surgery Clinic
ClinicalTrials.gov Identifier: NCT01816789    
Other Study ID Numbers: ANDROS-01-13
First Posted: March 22, 2013    Key Record Dates
Last Update Posted: December 23, 2016
Last Verified: October 2016
Keywords provided by Andros Day Surgery Clinic:
Starting dose
rFSH
controlled
ovarian
stimulation
IVF/ICSI
cycles
Additional relevant MeSH terms:
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Buserelin
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs