Prognostic Value of Progesterone for In Vitro Fertilizati... | NCT01067664

Studies
Prognostic Value of Progesterone for In Vitro Fertilization (IVF) Outcome

NCT01067664

Sponsor

Aristotle University Of Thessaloniki

Status

Completed

Last Update Posted

Oct 18, 2013Estimated

Enrollment

130Actual

Phase

Not provided

Conditions

Subfertility

Interventions

Not provided

Countries

Greece

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

Jun 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Jun 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

Nov 1, 2009

First Submission Date that Met QC Criteria

Feb 10, 2010

First Posted Date

Feb 11, 2010Estimated

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

Oct 17, 2013

Last Update Posted Date

Oct 18, 2013Estimated

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 observational study attempts to investigate the potential role of serum progesterone levels on the day of hCG administration (thus, the end of the follicular phase) on the probability of pregnancy, in patients undergoing IVF with the use of GnRH antagonists and recombinant gonadotrophins.

There has been evidence, that increased serum levels of progesterone are associated with a decreased probability of pregnancy after IVF.

This study will attempt to explore the role of progesterone on the outcome of IVF, by closely monitoring its levels during the late follicular phase.

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

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

130Actual

Label	Type	Description	Intervention Names
Patients undergoing IVF with rFSH and GnRH antagonists

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical pregnancy, defined as ultrasound evidence of fetal heart activity at 6-8 weeks of gestation		At 6-8 weeks of gestation

Secondary Outcomes

Measure	Description	Time Frame
Pregnancy (defined as a b-hCG> 25 IU/L)		12 days after embryo transfer

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age < 40 years
Basal FSH < 12 IU/L
Basal P < 1.6 ng/mL

Exclusion Criteria:

Presence of cystic formations at the ovaries during the basal ultrasound scan (prior the initiation of stimulation)
Women with polycystic ovaries syndrome (PCOS)
Women with Stage III-IV Endometriosis
Women with a pathological condition of the adrenal glands

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

39 Years

Standard Ages

Adult

Study Population

Women undergoing ovarian stimulation with the use of rFSH and GnRH antagonists for in-vitro fertilization.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Basil C Tarlatzis, MD, PhD	1st Dept. of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki	Principal Investigator
Christos A Venetis, MD, MSc	Unit for Human Reproduction, 1st Dept. of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Unit for Human Reproduction, 1st Dept. of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki		Thessaloniki			Greece

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided