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Is the IVF Outcome Dependent on the Time Interval Between hCG Administration and Oocyte Retrieval?

Primary Purpose

Subfertility

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Oocyte retrieval will be performed 36 h or 38 h after hCG administration
Sponsored by
Aristotle University Of Thessaloniki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subfertility focused on measuring IVF, hCG, oocyte retrieval, time interval

Eligibility Criteria

20 Years - 43 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • women undergoing fresh IVF cycle with recombinant FSH and GnRH antagonists
  • regular spontaneous menstrual cycle (24-35 days)
  • age ≤ 43 years
  • FSH ≤ 20 IU/L

Exclusion Criteria:

  • History of previous ovarian surgery
  • Women with Stage III-IV Endometriosis
  • Women undergoing natural cycle IVF

Sites / Locations

  • Unit for Human Reproduction, 1st Dept of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

36 h group

38 h group

Arm Description

Oocyte retrieval will be performed 36 hours after hCG administration

Oocyte retrieval will be performed 38 hours after hCG administration

Outcomes

Primary Outcome Measures

retrieval rate (cumulus-oocyte complexes/ follicles> 11 mm)

Secondary Outcome Measures

Clinical pregnancy rate (evidence of intrauterine sac with fetal heart activity at 6-8 weeks of gestation)
Total number of oocytes retrieved

Full Information

First Posted
October 10, 2013
Last Updated
May 26, 2014
Sponsor
Aristotle University Of Thessaloniki
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1. Study Identification

Unique Protocol Identification Number
NCT02044445
Brief Title
Is the IVF Outcome Dependent on the Time Interval Between hCG Administration and Oocyte Retrieval?
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aristotle University Of Thessaloniki

4. Oversight

5. Study Description

Brief Summary
During controlled ovarian hyperstimulation (COH), human chorionic gonadotrophin (hCG) is administered to trigger the final follicular maturation before oocyte retrieval, in an attempt to mimic the physiologic effects of LH. The hCG is administered when more than three follicles ≥17mm in mean diameter have developed. The time interval between hCG administration and oocyte retrieval is of critical importance since the time after luteinizing stimulus is a period of intense processes including the start of luteinization, expansion of cumulus cells and oocyte meiotic maturation. The commonly practiced hCG administration time of 33 to 36 h in most IVF cycles aims to avoiding spontaneous ovulation before oocyte retrieval. However, several studies have shown that significantly more high quality embryos have been obtained with a prolonged hCG-to-oocyte interval of 38 h. It has been hypothesized that longer interval would be beneficial in improving oocyte quality and achieving optimal maturation. Currently there are no data on the effect of the time interval between hCG administration and oocyte retrieval on IVF outcome in GnRH antagonist cycles. The aim of this study is to determine whether there is any difference in in vitro fertilization outcome when oocyte retrieval takes place at 36 h or 38 h following hCG administration

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subfertility
Keywords
IVF, hCG, oocyte retrieval, time interval

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
36 h group
Arm Type
Active Comparator
Arm Description
Oocyte retrieval will be performed 36 hours after hCG administration
Arm Title
38 h group
Arm Type
Active Comparator
Arm Description
Oocyte retrieval will be performed 38 hours after hCG administration
Intervention Type
Procedure
Intervention Name(s)
Oocyte retrieval will be performed 36 h or 38 h after hCG administration
Other Intervention Name(s)
oocyte retrieval at 36 hours following hCG administration, oocyte retrieval at 38 hours following hCG administration
Intervention Description
Oocyte retrieval will be performed 36 h or 38 h after hCG administration
Primary Outcome Measure Information:
Title
retrieval rate (cumulus-oocyte complexes/ follicles> 11 mm)
Time Frame
up to 38 h after hCG administration
Secondary Outcome Measure Information:
Title
Clinical pregnancy rate (evidence of intrauterine sac with fetal heart activity at 6-8 weeks of gestation)
Time Frame
At 6-8 weeks of gestation
Title
Total number of oocytes retrieved
Time Frame
up to 38 h after hCG administration

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: women undergoing fresh IVF cycle with recombinant FSH and GnRH antagonists regular spontaneous menstrual cycle (24-35 days) age ≤ 43 years FSH ≤ 20 IU/L Exclusion Criteria: History of previous ovarian surgery Women with Stage III-IV Endometriosis Women undergoing natural cycle IVF
Facility Information:
Facility Name
Unit for Human Reproduction, 1st Dept of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki
City
Thessaloniki
Country
Greece

12. IPD Sharing Statement

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Is the IVF Outcome Dependent on the Time Interval Between hCG Administration and Oocyte Retrieval?

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