- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02044445
Is the IVF Outcome Dependent on the Time Interval Between hCG Administration and Oocyte Retrieval?
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Thessaloniki, Greece
- Unit for Human Reproduction, 1st Dept of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 36 h group
Oocyte retrieval will be performed 36 hours after hCG administration
|
Oocyte retrieval will be performed 36 h or 38 h after hCG administration
Other Names:
|
Active Comparator: 38 h group
Oocyte retrieval will be performed 38 hours after hCG administration
|
Oocyte retrieval will be performed 36 h or 38 h after hCG administration
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
retrieval rate (cumulus-oocyte complexes/ follicles> 11 mm)
Time Frame: up to 38 h after hCG administration
|
up to 38 h after hCG administration
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
At 6-8 weeks of gestation
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Total number of oocytes retrieved
Time Frame: up to 38 h after hCG administration
|
up to 38 h after hCG administration
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UHR-10
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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