Evaluation of the Optimal Dose of GnRH Agonist for Trigge... | NCT01973842

Studies
Evaluation of the Optimal Dose of GnRH Agonist for Triggering Final Oocyte Maturation in High Risk OHSS Patients

NCT01973842

Sponsor

Aristotle University Of Thessaloniki

Status

Unknown status

Last Update Posted

Feb 12, 2016Estimated

Enrollment

90Estimated

Phase

Phase 2

Conditions

Subfertility

Interventions

0.1 mg triptorelin
0.2 mg triptorelin
0.4 mg triptorelin

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

Feb 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2014

Primary Completion Date

Jul 2016Estimated

Completion Date

Jul 2016Estimated

First Submitted Date

Oct 25, 2013

First Submission Date that Met QC Criteria

Oct 27, 2013

First Posted Date

Nov 1, 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

Feb 11, 2016

Last Update Posted Date

Feb 12, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

E.M. Kolibianakis, Ass Professor in Obstetrics - Gynecology and Assisted Reproduction, Aristotle University Of ThessalonikiPrincipal Investigator

Lead Sponsor

Aristotle University Of ThessalonikiOTHER

Collaborators

Name	Class
Eugonia IVF Unit, Athens, Greece	OTHER

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 present study aims to investigate whether the dosage of the GnRH agonist used for triggering final oocyte maturation affects the maturity of the oocytes retrieved in high risk for OHSS patients undergoing ovarian stimulation for IVF using GnRH antagonists and recombinant FSH.

Detailed Description

Three different doses of GnRH agonist (0.1mg, 0.2mg or 0.4 mg) will be used randomly to trigger final oocyte maturation. The primary outcome measure will be the percentage of mature oocytes retrieved.

Secondary outcomes will include: number of oocytes retrieved, oocyte recovery rate (number of oocytes retrieved/ number of follicles >11mm in diameter on the day of triggering), fertilization rates and OHSS occurrence.

Serum LH, FSH, E2, PRG levels will be assessed at 8-36 hours following agonist administration and on days 3-4-7-10 after triggering final oocyte maturation.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
0.2 mg triptorelin	Active Comparator	0.2 mg triptorelin compared with 0.1 mg triptorelin and 0.4 mg triptorelin	Drug: 0.2 mg triptorelin
0.1 mg triptorelin	Active Comparator	0.1 mg triptorelin compared with 0.2 mg triptorelin and 0.4 mg triptorelin	Drug: 0.1 mg triptorelin
0.4 mg triptorelin	Active Comparator	0.4 mg triptorelin compared with 0.1 mg triptorelin and 0.2 mg triptorelin	Drug: 0.4 mg triptorelin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
0.1 mg triptorelin	Drug		0.1 mg triptorelin
0.2 mg triptorelin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of mature oocytes retrieved	Percentage of mature oocytes retrieved following oocyte retrieval	36 hours post GnRH agonst administration

Secondary Outcomes

Measure	Description	Time Frame
total number of oocytes retrieved		36 hours post GnRH agonist administration
oocyte recovery rate		36 hours post GnRH agonist administration
Fertilization rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: Patients undergoing ovarian stimulation for IVF using GnRH antagonist protocol

Age < 40 years
Anticipated high ovarian response

Exclusion Criteria:

Endometriosis > than grade II
One ovary

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Efstratios Kolilbianakis, MD, MSc, PhD	Contact			stratis.kolibianakis@gmail.com
Georgios Lainas, MD	Contact			g.lainas@yahoo.co.uk

Overall Officials

Name	Affiliation	Role
Efstratios Kolibianakis, MD, MSc, PhD	Unit of Human Reproduction, 1st Dept of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki Thessaloniki, Greece	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eugonia IVF Unit	Recruiting	Athens			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

Intervention Browse Module

MeSH Terms

ID	Term
D017329	Triptorelin Pamoate

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