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Trial · Interventional

CompletedNot applicableRegistry data

IVF Treatment in Women With Immature Oocytes in Previous Cycle

NCTNCT02368964 (opens ClinicalTrials.gov in a new tab)Other idSHEBA-14-1817-YH-CTIL
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
100 participants (actual)
Sponsor
Sheba Medical Center · Other gov
Design
Randomized · Single masking
Countries
1 country

Israel

Start
1 Feb 2015
Primary completion
1 Jun 2020
Completion
1 Jun 2020
First posted
23 Feb 2015 (estimated)
Last update posted
24 Jun 2022
Conditions
Infertility

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2015201620172018201920202021
  1. N/A

    IVF Treatment in Women With Immature Oocytes in Previous Cycle

    NCT02368964

    1 Feb 2015 to 1 Jun 2020

Registry summary

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

In standard IVF stimulation cycle,human chorionic gonadotropin (hCG) is usually used at the end of controlled ovarian hyperstimulation (COH) as a surrogate to only the luteinizing hormone (LH) surge. Yet, the last dose of follicle stimulating hormone (FSH) is usually given between 12-24 hours before the hCG triggering dose.One protocol used at the investigators unit, after a cycle with low proportion of mature oocytes per number oocytes retrieved, is triggering with high dose hCG (500 mcg)-38 hours prior to oocyte aspiration. Lately, new researches showed that dual triggering of final oocyte maturation with a combination of GnRH- agonist and hCG, could improve the live-birth rate of normal responders undergoing the GnRH-antagonist COH protocol Another treatment option is high dose hCG. Only few case reports have described the use of high dose hCG after aspiration of non mature oocytes at a previous cycle. At the investigators IVF unit, patients with previous history of high percentage of immature oocytes retrieved, are triggered at the following cycle, either with double trigger or with high dose of hCG decided by the physician consulting the patient. It is still not known with which way of triggering more mature oocytes is retrieved. The aim of this study is to perform a prospective randomized controlled study in patients with low proportion of mature-MII oocytes oocytes (\<75%) per number oocytes retrieved, despite normal response to controlled ovarian hyperstimulation ( COH ) comparing cycles triggered with high dose hCG to those triggered with hCG+GnRH agonist.

Interventions

  • GnRH agonist 0.2 mg + hCG 250 mcgDrug
  • high dose hCG 500 mcgDrug

Arms2

  • Experimental

    High dose hCG

    The hCG group- will be triggered for final follicular maturation with high dose hCG (500 mcg)-38 hours prior to oocyte aspiration

  • Experimental

    Double trigger

    Double trigger Group- will receive GnRH agonist (Decapeptyl 0.2mg) 40 hours prior to oocyte aspiration and hCG (250mcg) 34 hours prior to the oocyte aspiration

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number MII oocytes per number of oocytes retrieved

    Time frame · day of retrieving the oocytes

    Registry description

    Rate of mature oocytes from total oocytes retrieved

Secondary outcomes(3)

  1. Total oocytes

    Time frame · day of retrieving the oocytes

  2. Pregnancy rate

    Time frame · Two weeks from induction of ovulation

  3. Number of top quality embryos

    Time frame · day of retrieving the oocytes

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: Observational study · 2013

4 results

Dual trigger with combination of gonadotropin-releasing hormone agonist and human chorionic gonadotropin significantly improves the live-birth rate for normal responders in GnRH-antagonist cycles.

Lin et al. 2013Fertility and sterilitycited by 110

PMID 23993928DOI 10.1016/j.fertnstert.2013.07.1976PUB-23993928

Full text at the publisher4 results
Publisher pageSee results (4)

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 42 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Patients with low proportion of mature-MII oocytes oocytes (75%) per number oocytes retrieved at the prior IVF cycle * Age between 18-42 Exclusion Criteria: * Women with high ovarian response:anti-mullerian hormone ( AMH) \>5, antral follicle count ( AFC) \>15 * more than 20 oocytes retrieved at the prior cycle.

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