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Optimizing Ovarian Stimulation for IVF and ICSI

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ClinicalTrials.gov Identifier: NCT01980563
Recruitment Status : Completed
First Posted : November 11, 2013
Last Update Posted : November 11, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Efficiency in Terms of Mature Oocyte Yield Procedure: ultrasound Procedure: combined monitoring Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 416 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimizing Ovarian Stimulation for IVF and ICSI
Study Start Date : January 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2012

Arm Intervention/treatment
Active Comparator: ultrasound Procedure: ultrasound
Procedure: combined monitoring
Active Comparator: combined monitoring Procedure: ultrasound
Procedure: combined monitoring



Primary Outcome Measures :
  1. The number of mature oocytes obtained. [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. The number of fertilized oocytes/good quality embryos [ Time Frame: at the moment of egg retrieval up to embryo transfer, assessed up to 100 months ]
  2. Pregnancy rate [ Time Frame: 12 months after egg retrieval ]
  3. clinical pregnancy rate [ Time Frame: 12 months after egg retrieval ]
  4. ongoing pregnancy rate [ Time Frame: 12 months after egg retrieval ]
  5. live birth rate for each individual transferred embryo [ Time Frame: 12 months after egg retrieval ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

inclusion criteria:

  • absence of ovarian cysts
  • both ovaries present

exclusion criteria:

  • ovarian cysts
  • not both ovaries present

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01980563


Locations
Belgium
University Hospital
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Frank Vandekerckhove, MD Fertility clinic

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01980563     History of Changes
Other Study ID Numbers: EC/2010/367
First Posted: November 11, 2013    Key Record Dates
Last Update Posted: November 11, 2013
Last Verified: November 2013