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NCT02813239 Clinical Trial

Dual Triggering in Patients With a High Immature Oocyte Rate

INFERTILITY Clinical Trial

Official title:
Dual Triggering With Gonadotropin-releasing Hormone Agonist and Standard Dose Human Chorionic Gonadotropin in Patients With a High Immature Oocyte Rate

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02813239
Other study ID # 1408-MAD-058-JG
Secondary ID
Status Completed
Phase N/A
First received June 16, 2016
Last updated June 23, 2016
Start date November 2014
Est. completion date November 2015

Study information
Verified date June 2016
Source IVI Madrid
Contact n/a
Is FDA regulated No
Health authority Spain: CEIC Puerta hierro
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 81
Est. completion date November 2015
Est. primary completion date November 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 43 Years
Eligibility Inclusion Criteria:

- BMI of 18-30 kg/m2

- Male factor required for ICSI

Exclusion Criteria:

Study Design

Observational Model: Case-Crossover, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Other:
• hCG
Oocyte maturation with hCG
• hCG + GnRH agonist
Oocyte maturation with hCG + GnRH agonist

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
IVI Madrid

References & Publications (2)

Fatemi HM, Garcia-Velasco J. Avoiding ovarian hyperstimulation syndrome with the use of gonadotropin-releasing hormone agonist trigger. Fertil Steril. 2015 Apr;103(4):870-3. doi: 10.1016/j.fertnstert.2015.02.004. Epub 2015 Feb 24. Review. — View Citation

Kohls G, Ruiz F, Martínez M, Hauzman E, de la Fuente G, Pellicer A, Garcia-Velasco JA. Early progesterone cessation after in vitro fertilization/intracytoplasmic sperm injection: a randomized, controlled trial. Fertil Steril. 2012 Oct;98(4):858-62. doi: 10.1016/j.fertnstert.2012.05.046. Epub 2012 Jun 29. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Metaphase II rate Number of metaphase II among total of recovered oocytes 1 day Yes
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