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

NCT ID: NCT01816789

Last Updated: 2016-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2016-07-31

Brief Summary

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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).

Detailed Description

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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

Conditions

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In Vitro Fertilization Ovarian Stimulation

Keywords

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Starting dose rFSH controlled ovarian stimulation IVF/ICSI cycles

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

rFSH

Intervention Type DRUG

buserelin

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

rFSH

Intervention Type DRUG

buserelin

Intervention Type DRUG

Interventions

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rFSH

Intervention Type DRUG

buserelin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Andros Day Surgery Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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ANDROS Day Surgery Clinic

Palermo, Sicily, Italy

Site Status

Countries

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Italy

Other Identifiers

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ANDROS-01-13

Identifier Type: -

Identifier Source: org_study_id