AMH and Pregnancy Rate by Age During Stimulate In-Vitro F... | NCT01762111

Studies
AMH and Pregnancy Rate by Age During Stimulate In-Vitro Fertilization Protocol

NCT01762111

Sponsor

Clinique Ovo

Status

Withdrawn

Last Update Posted

Jan 11, 2022Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Infertility

Interventions

Not provided

Countries

Canada

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

Jan 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Recruitment difficulties

Expanded Access Info

Start Date

Dec 2012Actual

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Jan 3, 2013

First Submission Date that Met QC Criteria

Jan 3, 2013

First Posted Date

Jan 7, 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

Jan 7, 2022

Last Update Posted Date

Jan 11, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The woman fertility decrease with the age and there is a closely link with the ovarian reserve, the number of available eggs in the ovaries. Therefore, it is important to evaluate the ovarian reserve with specific marker to have a better prediction of the response of the in vitro fertilization treatment and to have a better rate of pregnancy.

Until now, a lot of clinical criteria (age, duration of the infertility, number of antral follicles) and biological (FSH, Oestradiol, Inhibin B, EFFORT test, number of the eggs at the retrieval day) was suggested to help for the estimation of the ovarian reserve.

Since couple of years, the anti-müllerian hormone (AMH) is recognize to be one of the best ovarian reserve marker, it corresponding the number of antral follicles, it is more sensitive and predictive. Moreover, during the In-Vitro Fertilization, the anti-müllerian hormone can provide the weak responds at the stimulation and the reverse, the risk of excessive responds (hyperstimulation). To choose the gonadotropin doses to administrate (stimulation ovarian hormone) during an In-Vitro Fertilization protocol, we need to know the anti-müllerian hormone dosage. However, if the anti-müllerian hormone is recognize to evaluate the quantity of available eggs in the ovaries, his role to determine the quality of these eggs still discussed.

The goal of this study is to verify if the serum anti-müllerian hormone (blood) is a good indicator for the quality of the reserve ovarian evaluating the impact of anti-müllerian hormone rate on the pregnancy rate and implantation rate, during stimulate In-Vitro Fertilization protocol.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pregnancy rates	Clinical pregnancy rates per cycle and per transfer	7 weeks

Secondary Outcomes

Measure	Description	Time Frame
Cumulative pregnancy rates	Cumulative pregnancy rates including all frozen embryo transfer	5 years
Number of eggs	Number of eggs retrieve at the end of the stimulated in-vitro fertilization cycle

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All infertile patients aged between 18 and 43 years
Patients with a prescription for a stimulated In-Vitro Fertilization cycle

Exclusion Criteria:

Presence of endocrine disease: diabetes, hyperprolactinemia, abnormal thyroid-stimulating hormone (TSH) or Cushing syndrome
Renal or hepatic impairment known

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

43 Years

Standard Ages

Adult

Study Population

Women followed at the clinique ovo, aged between 18 and 43 years old undergoing a stimulate In-Vitro Fertilization cycle.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jacques Kadoch, MD	Clinique Ovo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinique Ovo		Montreal	Quebec	H4P 2S4	Canada

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

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Browse Branches

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