Optimizing Ovarian Stimulation for IVF and ICSI

Monitoring ovarian stimulation for in vitro fertilization (IVF) and intracytoplasmatic sperm injection (ICSI) can be simplified by reducing the procedure to measuring follicles by ultrasound. Proponents of a simplified procedure claim that the procedure can be reduced to simple monitoring by ultrasound while maintaining results (numbers of mature oocytes, percentage of pregnancy and live birth rates). On the other hand simultaneous blood sampling for measuring hormone levels is still the state of the art in many clinics. A large review (Cochrane review) stated that "although there was no clear evidence for a better outcome, combined cycle monitoring was still recommended until it could be proven that ovarian hyperstimulation can be avoided without hormonal monitoring". Investigators therefore perform a study that compares the results between 2 groups: those with ultrasound monitoring and those with combined monitoring. Deciding when to plan the retrieval of the oocytes can depend on subtle differences in the number of large follicles measured by ultrasound, but also on hormonal levels in the blood of the patient. Therefore the investigators planned a randomized study in the group of patients with combined monitoring. The investigators examined if delaying the moment for planning the moment of oocyte retrieval by 24 hours had any effect on the number of mature oocytes and pregnancy rates and what the effect of rising progesterone levels might be. The investigators hypothesis was that combined monitoring could lead to better results since recent studies have thought that rising progesterone levels, if found, have a negative impact on pregnancy rates. On the other hand the investigators expect to find that waiting for larger follicles in cases with normal progesterone levels lead to a better oocyte yield.

Study Overview

• Status: Completed
• Conditions: Efficiency in Terms of Mature Oocyte Yield
• Intervention / Treatment: Procedure: ultrasound; Procedure: combined monitoring

• Study Type: Interventional
• Enrollment (Actual): 416
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

inclusion criteria:

• absence of ovarian cysts
• both ovaries present

exclusion criteria:

• ovarian cysts
• not both ovaries present

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ultrasound	Procedure: ultrasound; Procedure: combined monitoring
Active Comparator: combined monitoring	Procedure: ultrasound; Procedure: combined monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The number of mature oocytes obtained.	1 day

Secondary Outcome Measures

Outcome Measure	Time Frame
The number of fertilized oocytes/good quality embryos	at the moment of egg retrieval up to embryo transfer, assessed up to 100 months
Pregnancy rate	12 months after egg retrieval
clinical pregnancy rate	12 months after egg retrieval
ongoing pregnancy rate	12 months after egg retrieval
live birth rate for each individual transferred embryo	12 months after egg retrieval

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Investigators: Principal Investigator: Frank Vandekerckhove, MD, Fertility Clinic

Publications and helpful links

General Publications

• Vandekerckhove F, Gerris J, Vansteelandt S, De Baerdemaeker A, Tilleman K, De Sutter P. Delaying the oocyte maturation trigger by one day leads to a higher metaphase II oocyte yield in IVF/ICSI: a randomised controlled trial. Reprod Biol Endocrinol. 2014 Apr 23;12:31. doi: 10.1186/1477-7827-12-31.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: October 24, 2013
• First Submitted That Met QC Criteria: November 4, 2013
• First Posted (Estimate): November 11, 2013

Study Record Updates

• Last Update Posted (Estimate): November 11, 2013
• Last Update Submitted That Met QC Criteria: November 4, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: EC/2010/367