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Dual Triggering in Patients With a High Immature Oocyte Rate

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ClinicalTrials.gov Identifier: NCT02813239
Recruitment Status : Completed
First Posted : June 24, 2016
Last Update Posted : June 24, 2016
Sponsor:
Information provided by (Responsible Party):
Juan A Garcia-Velasco, IVI Madrid

Tracking Information
First Submitted Date June 16, 2016
First Posted Date June 24, 2016
Last Update Posted Date June 24, 2016
Study Start Date November 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 23, 2016)
Metaphase II rate [ Time Frame: 1 day ]
Number of metaphase II among total of recovered oocytes
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Dual Triggering in Patients With a High Immature Oocyte Rate
Official Title Dual Triggering With Gonadotropin-releasing Hormone Agonist and Standard Dose Human Chorionic Gonadotropin in Patients With a High Immature Oocyte Rate
Brief Summary In in vitro fertilization (IVF) cycles, even after adequate triggering, some patients present a high rate of immature oocytes retrieved after controlled ovarian stimulation. In vitro oocyte maturation is still an experimental technique, with poorer results than conventional IVF. For that reason improve in in vivo maturation could have a better impact on reproductive outcome.
Detailed Description Investigators performed an observational study analyzing the difference in the percentage of mature oocytes retrieved in patients with more than 50% immature oocytes in a previous IVF cycle triggered with human chorionic gonadotropin (rhCG) compared to the rate of mature oocytes retrieved in subsequent cycles, triggered with both gonadotropin-releasing hormone agonist (GnRHa) and (hCG). The main outcome measure was the number and percentage of mature oocytes retrieved.
Study Type Observational
Study Design Observational Model: Case-Crossover
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Women undergoing controlled ovarian stimulation with a high immature oocyte rate
Condition INFERTILITY
Intervention
  • Other: hCG
    Oocyte maturation with hCG
    Other Name: OVITRELLE (Merck Serono)
  • Other: hCG + GnRH agonist
    Oocyte maturation with hCG + GnRH agonist
    Other Name: Ovitrelle (Merck Serono) + Decapeptyl (Ipsen Pharma)
Study Groups/Cohorts
  • HCG triggering
    Patients were scheduled by prescribing oral contraceptive (OC) for 12-16 days and recombinant FSH and/or highly purified u-hMG according to the patient's age, BMI, antral follicular count, AMH and previous responses to ovarian controlled stimulation. GnRH antagonist was added when at least one follicle reached 13 mm. Ovulation was induced by hCG when at least 2 follicles had a mean diameter of 17 mm.
    Intervention: Other: hCG
  • HCG + GnRH agonist triggering
    Patients were scheduled by prescribing oral contraceptive (OC) for 12-16 days and recombinant FSH and/or highly purified u-hMG according to the patient's age, BMI, antral follicular count, AMH and previous responses to ovarian controlled stimulation. GnRH antagonist was added when at least one follicle reached 13 mm. Ovulation was induced by hCG and GnRH agonist when at least 2 follicles had a mean diameter of 17 mm.
    Intervention: Other: hCG + GnRH agonist
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 23, 2016)
81
Original Actual Enrollment Same as current
Actual Study Completion Date November 2015
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • BMI of 18-30 kg/m2
  • Male factor required for ICSI

Exclusion Criteria:

-

Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 43 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02813239
Other Study ID Numbers 1408-MAD-058-JG
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Juan A Garcia-Velasco, IVI Madrid
Study Sponsor IVI Madrid
Collaborators Not Provided
Investigators
Principal Investigator: Juan Antonio Garcia Velasco, MD IVI Madrid
PRS Account IVI Madrid
Verification Date June 2016