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 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Academic Medical Centre
Centre for Reproductive Medicine
Amsterdam
1100 DE
Netherlands
| M.H.Mochtar@amc.uva.nl |
Study information
| Study design | Randomised, active-controlled, parallel group, multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/04/2006 |
| Completion date | 01/04/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 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
1100 DE
Netherlands
Sponsor information
Academic Medical Centre (AMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Center For Reproductive Medicine
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Website | http://www.amc.uva.nl/#http://www.amc.uva.nl/ |
|---|---|
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Industry
Organon (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
