Optimizing Ovarian Stimulation for IVF and ICSI

Not Applicable

Completed

• Conditions: Efficiency in Terms of Mature Oocyte Yield
• Interventions: Procedure: ultrasound; Procedure: combined monitoring

• Registration Number: NCT01980563
• Lead Sponsor: University Hospital, Ghent

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2011-12
• Study Completion: 2012-12
• Study First Submitted: 2013-10-24
• Status Verified: 2013-11
• Study First Submitted QC: 2013-11-04
• Last Update Submitted: 2013-11-04
• Study First Posted: 2013-11-11
• Last Update Posted: 2013-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 416

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ultrasound	ultrasound	-
ultrasound	combined monitoring	-
combined monitoring	ultrasound	-
combined monitoring	combined monitoring	-

Primary Outcome Measures

Name	Time	Method
The number of mature oocytes obtained.	1 day

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital; 🇧🇪 Ghent, Belgium