Condition category
Pregnancy and Childbirth
Date applied
08/02/2007
Date assigned
08/02/2007
Last edited
15/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.studies-obsgyn.nl

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 measures

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

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

http://www.amc.uva.nl/#http://www.amc.uva.nl/

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

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21362684

Publication citations

  1. 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.

Additional files

Editorial Notes