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Trial · Interventional

CompletedNot applicableRegistry data

GnRHa Trigger in Asian Oocyte Donors- a Dose Finding Study

NCTNCT02208986 (opens ClinicalTrials.gov in a new tab)Other idNCKH/CGRH_01_2014
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
165 participants (actual)
Sponsor
Vietnam National University · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Vietnam

Start
Aug 2014
Primary completion
Feb 2015
Completion
Mar 2015
First posted
5 Aug 2014 (estimated)
Last update posted
6 Feb 2017 (estimated)
Conditions
Normal Oocyte Donors

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201420152016
  1. N/A

    GnRHa Trigger in Asian Oocyte Donors- a Dose Finding Study

    NCT02208986

    Aug 2014 to Mar 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • TriptorelinDrug

Arms3

  • Active comparator

    0.2mg Triptorelin

    Ovulation trigger with 0.2mg Triptorelin in one subcutaneous injection.

  • Active comparator

    0.3mg Triptorelin

    Ovulation trigger with 0.3mg Triptorelin in one subcutaneous injection.

  • Active comparator

    Active Comparator: 0.4mg Triptorelin

    Ovulation trigger with 0.4mg Triptorelin in one subcutaneous injection.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of mature oocytes

    Time frame · 30 minutes after oocyte retrieval completed

Secondary outcomes(2)

  1. Day of bleeding after oocyte pick-up

    Time frame · in 2 weeks after oocyte pick-up

  2. Clinical pregnancy

    Time frame · 5 weeks after oocyte pick-up

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2016

10 results

Gonadotropin-releasing hormone agonist trigger in oocyte donors co-treated with a gonadotropin-releasing hormone antagonist: a dose-finding study.

Vuong et al. 2016Fertility and sterilitycited by 43

PMID 26523330DOI 10.1016/j.fertnstert.2015.10.014PUB-26523330

Full text at the publisher10 results
Publisher pageSee results (10)

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 35 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 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. Exclusion Criteria: * 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

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