Follicle diameter study: timing of human chorionic gonadotropin administration according to predetermined criteria of follicular size

ISRCTN	ISRCTN24724622
DOI	https://doi.org/10.1186/ISRCTN24724622
Protocol serial number	N/A
Sponsor	Academic Medical Centre (AMC) (The Netherlands)
Funder	Organon (The Netherlands)

Submission date: 08/02/2007
Registration date: 08/02/2007
Last edited: 15/08/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr M H Mochtar
Scientific

Academic Medical Centre
Centre for Reproductive Medicine
Amsterdam
1100 DE
Netherlands

Email	M.H.Mochtar@amc.uva.nl

Study information

Primary study design	Interventional
Study design	Randomised, active-controlled, parallel group, multicentre trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Approval received from the Ethics Board of the Academical Medical Center, Amsterdam, on the 20th July 2005 (ref: MEC 05/161 #05.17.1237).
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Human Chorionic Gonadotropin (hCG)
Primary outcome measure(s)	Ongoing pregnancy rate, defined as a positive foetal heartbeat by ultrasound at ten weeks after oocyte retrieval.
Key secondary outcome measure(s)	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
Completion date	01/04/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	400
Key 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
Key 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)
Date of first enrolment	01/04/2006
Date of final enrolment	01/04/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

Academic Medical Centre

Amsterdam
1100 DE
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2011		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes