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

Subfertility Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02044445
• Other study ID #: UHR-10
• Status: Completed
• Phase: N/A
• First received: October 10, 2013
• Last updated: May 26, 2014
• Start date: November 2009

Study information

• Verified date: May 2014
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 43 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Subfertility

Intervention

Procedure:
• Oocyte retrieval will be performed 36 h or 38 h after hCG administration
Oocyte retrieval will be performed 36 h or 38 h after hCG administration

Locations

Country	Name	City	State
Greece	Unit for Human Reproduction, 1st Dept of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	retrieval rate (cumulus-oocyte complexes/ follicles> 11 mm)		up to 38 h after hCG administration	No
Secondary	Clinical pregnancy rate (evidence of intrauterine sac with fetal heart activity at 6-8 weeks of gestation)		At 6-8 weeks of gestation	No
Secondary	Total number of oocytes retrieved		up to 38 h after hCG administration	No