Dual Triggering in Patients With a High Immature Oocyte Rate

June 23, 2016 updated by: Juan A Garcia-Velasco, IVI Madrid

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

81

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women undergoing controlled ovarian stimulation with a high immature oocyte rate

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: hCG
Oocyte maturation with hCG
Other Names:
  • OVITRELLE (Merck Serono)
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.
Other: hCG + GnRH agonist
Oocyte maturation with hCG + GnRH agonist
Other Names:
  • Ovitrelle (Merck Serono) + Decapeptyl (Ipsen Pharma)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metaphase II rate
Time Frame: 1 day
Number of metaphase II among total of recovered oocytes
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IVI Madrid

Investigators

  • Principal Investigator: Juan Antonio Garcia Velasco, MD, IVI Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

June 16, 2016

First Submitted That Met QC Criteria

June 23, 2016

First Posted (Estimate)

June 24, 2016

Study Record Updates

Last Update Posted (Estimate)

June 24, 2016

Last Update Submitted That Met QC Criteria

June 23, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1408-MAD-058-JG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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