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

NCT02044445 | Completed

• 1 other identifier: UHR-10
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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

Conditions

Subfertility

Keywords

IVF, hCG, oocyte retrieval, time interval

Outcome Measures

Primary Outcomes (1)

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

  up to 38 h after hCG administration

Secondary Outcomes (2)

• Clinical pregnancy rate (evidence of intrauterine sac with fetal heart activity at 6-8 weeks of gestation)

  At 6-8 weeks of gestation

• Total number of oocytes retrieved

  up to 38 h after hCG administration

Study Arms (2)

36 h group

ACTIVE COMPARATOR

Oocyte retrieval will be performed 36 hours after hCG administration

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

38 h group

ACTIVE COMPARATOR

Oocyte retrieval will be performed 38 hours after hCG administration

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

Interventions

Oocyte retrieval will be performed 36 h or 38 h after hCG administration PROCEDURE

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

Also known as: oocyte retrieval at 36 hours following hCG administration, oocyte retrieval at 38 hours following hCG administration

36 h group; 38 h group

Eligibility Criteria

• Age: 20 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

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

Thessaloniki, Greece

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 10, 2013
• First Posted: January 24, 2014
• Study Start: November 1, 2009
• Primary Completion: December 1, 2013
• Last Updated: May 28, 2014

Record last verified: 2014-05

Locations

GR (1)