Optimizing Ovarian Stimulation for IVF and ICSI

Study Overview
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Brief Summary
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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.

Official Title
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Optimizing Ovarian Stimulation for IVF and ICSI

Conditions
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Efficiency in Terms of Mature Oocyte Yield

Intervention / Treatment
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* Procedure: ultrasound
* Procedure: combined monitoring


Participation Criteria
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Eligibility Criteria
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inclusion criteria: absence of ovarian cysts both ovaries present exclusion criteria: ovarian cysts not both ovaries present

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ultrasound<br> | Procedure: ultrasound<br> <br> Procedure: combined monitoring<br> <br> |
| Active Comparator: combined monitoring<br> | Procedure: ultrasound<br> <br> Procedure: combined monitoring<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |