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OpenTrials
Completed

NCT Number: NCT01980563

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • absence of ovarian cysts
  • both ovaries present

Exclusion criteria

  • ovarian cysts
  • not both ovaries present

Treatment and study plan

Ultrasound

Procedure

combined monitoring

Procedure

Primary outcomes

  1. The number of mature oocytes obtained.

    Time frame: 1 day

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Nov 11, 2013
Registry last updated
Nov 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.