Age Versus Ovarian Reserve Markers Based Therapy in IVF (... | NCT01816789

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

NCT01816789

Sponsor

Andros Day Surgery Clinic

Status

Terminated

Last Update Posted

Dec 23, 2016Estimated

Enrollment

194Actual

Phase

Phase 4

Conditions

In Vitro Fertilization
Ovarian Stimulation

Interventions

rFSH
buserelin

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Optimal response: 63% nomogram, 42% controls, overcoming the stopping rule for interim analysis

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Jul 2016Actual

Completion Date

Jul 2016Actual

First Submitted Date

Mar 20, 2013

First Submission Date that Met QC Criteria

Mar 21, 2013

First Posted Date

Mar 22, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 22, 2016

Last Update Posted Date

Dec 23, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

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:

Serum E2 levels on r-hCG day
Serum P levels on r-hCG day
Number of growing follicles (≥11mm) on r-hCG day
Number of large (≥ 17 mm) ovarian follicles on r-hCG day
Total r-FSH dose employed
Treatment duration
Rate of women with dose adjustment
Number of cancelled cycles because of poor and hyper-response
Fertilization rate
Embryos obtained
Implantation rates
Biochemical pregnancy rates
Clinical pregnancy rates
OHSS rates

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

194Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
rFSH	Drug		Group A: "age" Group B: "nomogram"
buserelin

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ANDROS Day Surgery Clinic		Palermo	Sicily	90144	Italy

Intervention Browse Module

MeSH Terms

ID	Term
D002064	Buserelin

Ancestor Terms

ID	Term
D007987	Gonadotropin-Releasing Hormone
D010906	Pituitary Hormone-Releasing Hormones
D007028	Hypothalamic Hormones
D036361	Peptide Hormones

Browse Leaves

Not provided

Browse Branches

Not provided