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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR876 |
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Date of registration:
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22/01/2007 |
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Primary sponsor: |
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Public title:
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Follikel diameter studie
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Scientific title:
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Timing of hCG administration according to predetermined criteria of follicular size. -
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Date of first enrolment:
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1/4/2006 |
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Target sample size:
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400 |
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Recruitment status: |
recruiting |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=876 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: -
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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Fulco
Veen, van der |
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Address:
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Academic Medical Center (AMC), Department of Obstetrics and Gynecology, Center For Reproductive Medicine,
P.O. Box 22660, Meibergdreef 9
1100 DD
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20 5663557 |
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Email:
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F.vanderVeen@amc.uva.nl |
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Affiliation:
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Name:
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M.H.
Mochtar |
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Address:
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Academical Medical Center, Center for Reproductive Medicine, Postbox 22700
1100 DE
Amsterdam
The Netherlands |
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Telephone:
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Email:
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M.H.Mochtar@amc.uva.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Age between 18 and 42 and 11 months;
2. Valid indication for IVF or ICSI;
3. Undergoing their first or second IVF/ICSI attempt;
4. Normal FSH levels (< 15);
5. Antral follicle count > 5 for women between 40 and 43.
Exclusion criteria: 1. Endocrinopathological disease as: PCOS, cushing syndrome, adrenal hyperplasia, hyperprolactinaemia, acromegaly, hypothalamic amenorrhea, hypothyroidy, diabetes mellitus type I;
2. Premature ovarian failure defined as a FSH level on cycle-day 3 of ¡Ý 15 IU at the age of 40;
3. Low responders defined as follicle growth of less than 3 follicles during controlled ovarian hyperstimulation (including the dominant follicle).
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Timing Humane Chorion Gonadotropine (HCG), Follicle size, In vitro fertilization (IVF)
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Intervention(s)
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hCG administration for follicular maturation when the dominant follicle measures 18 mm compared to hCG administration for follicular maturation when the dominant follicle measures 22 mm
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Primary Outcome(s)
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Ongoing pregnancy rate, defined as a positive foetal heartbeat by ultrasound at 10 weeks after oocyte retrieval.
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Secondary Outcome(s)
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Endometrium thickness, 3-layer aspect
Total days of controlled hyper stimulation
Total amount of rFSH used
Total number of retrieved oocytes
Number of Score I oocytes (IVF only)
Number of metaphase II oocytes (ICSI only)
Fertilization rate
Number and quality of embryos
Pronuclear morphology
Presence of early cleavage
Daily morphological quality of embryos until transfer
Number of embryos suited for cryo-preservation
OHSS/ discontinuation due a high risk of OHSS
Biochemical and clinical pregnancy rates, defined as a increase in serum HCG or a positive pregnancy test and positive heartbeat by ultrasound at 7 weeks after oocyte retrieval, respectively.
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Secondary ID(s)
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ISRCTN24724622
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N/A
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Source(s) of Monetary Support
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Organon
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