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

NCT ID: NCT01973842

Last Updated: 2016-02-12

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2016-07-31

Brief Summary

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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

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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.

Conditions

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Subfertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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0.2 mg triptorelin

0.2 mg triptorelin compared with 0.1 mg triptorelin and 0.4 mg triptorelin

Group Type ACTIVE_COMPARATOR

0.2 mg triptorelin

Intervention Type DRUG

0.1 mg triptorelin

0.1 mg triptorelin compared with 0.2 mg triptorelin and 0.4 mg triptorelin

Group Type ACTIVE_COMPARATOR

0.1 mg triptorelin

Intervention Type DRUG

0.4 mg triptorelin

0.4 mg triptorelin compared with 0.1 mg triptorelin and 0.2 mg triptorelin

Group Type ACTIVE_COMPARATOR

0.4 mg triptorelin

Intervention Type DRUG

Interventions

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0.1 mg triptorelin

Intervention Type DRUG

0.2 mg triptorelin

Intervention Type DRUG

0.4 mg triptorelin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age \< 40 years
* Anticipated high ovarian response

Exclusion Criteria

* Endometriosis \> than grade II
* One ovary
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Eugonia IVF Unit, Athens, Greece

OTHER

Sponsor Role collaborator

Aristotle University Of Thessaloniki

OTHER

Sponsor Role lead

Responsible Party

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E.M. Kolibianakis

Ass Professor in Obstetrics - Gynecology and Assisted Reproduction

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Efstratios Kolibianakis, MD, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

Unit of Human Reproduction, 1st Dept of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki Thessaloniki, Greece

Locations

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Eugonia IVF Unit

Athens, , Greece

Site Status RECRUITING

Unit of Human Reproduction, 1st Dept of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki

Thessaloniki, , Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Efstratios Kolilbianakis, MD, MSc, PhD

Role: CONTACT

Georgios Lainas, MD

Role: CONTACT

Facility Contacts

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Trifon Lainas, MD, PhD

Role: primary

Efstratios Kolibianakis, MD, MSc, PhD

Role: primary

Other Identifiers

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Agonist triggering dose

Identifier Type: -

Identifier Source: org_study_id

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