NCT02208986

Brief Summary

The aim of this randomized single center study is to explore the most optimal dose of GnRHa used for triggering of final oocyte maturation in IVF. The study group will consist of oocyte donors who have GnRHa trigger as a standard trigger concept. Hypothesis: In an Asian oocyte donor population, the use of 0.2 mg, 0.3mg or 0.4 mg of GnRHa will lead to the retrieval of comparable numbers of mature oocytes (MII) and good quality embryos. Moreover, the reproductive outcome in the recipients will be similar regardless of the dose of GnRHa used for trigger.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2014

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

February 6, 2017

Status Verified

February 1, 2017

Enrollment Period

6 months

First QC Date

July 29, 2014

Last Update Submit

February 2, 2017

Conditions

Normal Oocyte Donors

Keywords

GnRH antagonistGnRH agonist triggerOocyte donor

Outcome Measures

Primary Outcomes (1)

  • Number of mature oocytes

    30 minutes after oocyte retrieval completed

Secondary Outcomes (2)

  • Day of bleeding after oocyte pick-up

    in 2 weeks after oocyte pick-up

  • Clinical pregnancy

    5 weeks after oocyte pick-up

Study Arms (3)

0.2mg Triptorelin

ACTIVE COMPARATOR

Ovulation trigger with 0.2mg Triptorelin in one subcutaneous injection.

Drug: Triptorelin

0.3mg Triptorelin

ACTIVE COMPARATOR

Ovulation trigger with 0.3mg Triptorelin in one subcutaneous injection.

Drug: Triptorelin

Active Comparator: 0.4mg Triptorelin

ACTIVE COMPARATOR

Ovulation trigger with 0.4mg Triptorelin in one subcutaneous injection.

Drug: Triptorelin

Interventions

TriptorelinDRUG

Triptorelin is given by s.c injection for ovulation triggering.

Also known as: Diphereline 0.1 mg powder and solvent
0.2mg Triptorelin0.3mg TriptorelinActive Comparator: 0.4mg Triptorelin

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Oocyte donors who meet the following criteria:
  • Age 18 - 35
  • BMI \< 28kg/m2
  • Normal ovarian reserve, defined by AMH \> 1.25 ng/ml or AFC ≥ 6 measured within two months prior to stimulation start
  • Receiving GnRH-antagonist protocol for ovarian stimulation,
  • Agreement to participate in the study, and to disclose any medical events to the investigator. The subject must be willing and able to comply with the protocol requirements for the duration of the study.
  • Have given written informed consent with the understanding that the subject may withdraw consent at any time without prejudice to future medical care.

You may not qualify if:

  • Previous poor response (≤ 3 oocytes) after high dose FSH stimulation
  • Chronical medical conditions like Diabetes, Crohns disease, Thyroid disease, Hepatitis B and Sexually Transmitted Diseases Simultaneous participation in an interventional clinical trial.
  • Concommitant use of either LH or hMG/uFSH preparations in study cycle

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

My Duc Hospital, IVFMD

Ho Chi Minh City, Ho Chi Minh, Vietnam

Location

Related Publications (1)

  • Vuong TN, Ho MT, Ha TD, Phung HT, Huynh GB, Humaidan P. Gonadotropin-releasing hormone agonist trigger in oocyte donors co-treated with a gonadotropin-releasing hormone antagonist: a dose-finding study. Fertil Steril. 2016 Feb;105(2):356-63. doi: 10.1016/j.fertnstert.2015.10.014. Epub 2015 Oct 31.

    PMID: 26523330DERIVED

MeSH Terms

Interventions

Triptorelin PamoatePowdersSolvents

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteinsDosage FormsPharmaceutical PreparationsSpecialty Uses of ChemicalsChemical Actions and Uses

Study Officials

  • Tuong M Ho, MD

    CGRH, School of Medicine, Vietnam National University HCMC, Vietnam

    PRINCIPAL INVESTIGATOR

  • Lan TN Vuong, MD

    Department of Obstetrics and Gynecology, University of Medicine and Pharmacy HCMC, Ho Chi Minh City, Vietnam

    PRINCIPAL INVESTIGATOR

  • Peter Humaidan, MD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

July 29, 2014

First Posted

August 5, 2014

Study Start

August 1, 2014

Primary Completion

February 1, 2015

Study Completion

March 1, 2015

Last Updated

February 6, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

VN(1)