Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr M H Mochtar
ORCID ID
Contact details
Academic Medical Centre
Centre for Reproductive Medicine
Amsterdam
1100 DE
Netherlands
M.H.Mochtar@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
To assess whether delayed administration of human Chorionic Gonadotropin (hCG) for controlled ovarian hyperstimulation for In Vitro Fertilisation (IVF) and embryo transfer leads to an increased advanced stage of endometrium, and prolonged exposure to high levels of estradiol which may result in a lower pregnancy rate.
Ethics approval
Approval received from the Ethics Board of the Academical Medical Center, Amsterdam, on the 20th July 2005 (ref: MEC 05/161 #05.17.1237).
Study design
Randomised, active-controlled, parallel group, multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
In Vitro Fertilisation (IVF), timing of human Chorionic Gonadotropin (hCG) administration, follicle size
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
Human Chorionic Gonadotropin (hCG)
Primary outcome measure
Ongoing pregnancy rate, defined as a positive foetal heartbeat by ultrasound at ten weeks after oocyte retrieval.
Secondary outcome measures
1. Endometrium thickness, three-layer aspect
2. Total days of controlled hyper stimulation
3. Total amount of recombinant FSH (rFSH) used
4. Total number of retrieved oocytes
5. Number of score one oocytes (IVF only)
6. Number of metaphase two oocytes (ICSI only)
7. Fertilisation rate
8. Number and quality of embryos
9. Pronuclear morphology
10. Presence of early cleavage
11. Daily morphological quality of embryos until transfer
12. Number of embryos suited for cryo-preservation
13. Ovarian Hyper-Stimulation Syndrome (OHSS)/discontinuation due a high risk of OHSS
14. Biochemical and clinical pregnancy rates, defined as a increase in serum hCG or a positive pregnancy test and positive heartbeat by ultrasound at seven weeks after oocyte retrieval, respectively
Overall trial start date
01/04/2006
Overall trial end date
01/04/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age between 18 and 42 and 11 months
2. Valid indication for IVF or Intra-Cytoplasmic Sperm Injection (ICSI)
3. Undergoing their first or second IVF/ICSI attempt
4. Normal Follicle-Stimulating Hormone (FSH) levels (less than 15)
5. Antral follicle count more than five for women between 40 and 43
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
400
Participant exclusion criteria
1. Endocrinopathological disease as: Poly-Cystic Ovarian Syndrome (PCOS), cushing syndrome, adrenal hyperplasia, hyperprolactinaemia, acromegaly, hypothalamic amenorrhoea, hypothyroidy, diabetes mellitus type one
2. Premature ovarian failure defined as a FSH level on cycle-day three of more than or equal to 15 IU at the age of 40
3. Low responders defined as follicle growth of less than three follicles during controlled ovarian hyperstimulation (including the dominant follicle)
Recruitment start date
01/04/2006
Recruitment end date
01/04/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Centre
Amsterdam
1100 DE
Netherlands
Sponsor information
Organisation
Academic Medical Centre (AMC) (The Netherlands)
Sponsor details
Center For Reproductive Medicine
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Organon (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21362684
Publication citations
-
Results
Mochtar MH, Custers IM, Koks CA, Bernardus RE, Verhoeve HR, Mol BW, van Wely M, van der Veen F, Timing oocyte collection in GnRH agonists down-regulated IVF and ICSI cycles: a randomized clinical trial., Hum. Reprod., 2011, 26, 5, 1091-1096, doi: 10.1093/humrep/der048.