search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Triptorelin Oral contraceptive Pill Flare-up in IVF/ICSI Treatment trial.


- candidate number9126
- NTR NumberNTR2759
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-feb-2011
- Secondary IDs2010/118 METc VUmc
- Public TitleTriptorelin Oral contraceptive Pill Flare-up in IVF/ICSI Treatment trial.
- Scientific TitleTriptorelin Oral contraceptive Pill Flare-up in IVF/ICSI Treatment trial.
- ACRONYMTOPFIT trial
- hypothesisThe aim of the study is to show non-inferiority of a short, flare-up GnRH-agonist protocol to the GnRH-antagonist protocol, both with OC pill pre-treatment, in women undergoing in vitro fertilisation (IVF) or intracellular sperm injection (ICSI) treatment with gonadotrophins.
- Healt Condition(s) or Problem(s) studiedSubfertility, Ovulation, LH surge, GnRH-agonist, GnRH-antagonist
- Inclusion criteriaAny woman undergoing IVF/ICSI treatment (first, second or third cycle) is eligible to participate in the trial. A patient can only participate once in the study. Signed informed consent is mandatory.
- Exclusion criteria1. Women aged over 39 years;
2. Women with a single ovary;
3. Known poor responders, defined as women with a follicle count of < 4 follicles > 14 mm in a previous IVF/ICSI treatment cycle;
4. History or evidence of polycystic ovary syndrome (PCOS) or incipient ovarian failure;
5. Severe endometriosis, stage III/IV, needing Surrey stimulation protocol;
6. Women with known contraindications for oral OCs.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2011
- planned closingdate
- Target number of participants200
- Interventions1. Flare-up GnRH-agonist protocol with OC pill pre-treatment. OC pill is given during 21±3 days of the preceding cycle. On day two of the menses after withdrawal of the OC pill of the following cycle, triptorelin is started, accompanied at day three by HP-hMG in a fixed dose of 150 IU. Both are given until criteria for hCG administration are met;
2. GnRH-antagonist protocol with OC pill pre-treatment. OC pill is given during 21±3 days of the preceding cycle. On day three of the menses of the following cycle, HP-hMG (fixed dose of 150 IU) is started and accompanied by cetrorelix at day six of gonadotrophin administration, both given until criteria for hCG administration are met.
- Primary outcomeTo assess non-inferiority of the short, flare-up GnRH-agonist protocol compared to the GnRH-antagonist protocol, both with OC pill pre-treatment, with respect to incidence of premature serum LH surges, with or without a rise in progesterone, in patients treated with IVF/ICSI for subfertility.
- Secondary outcomeTo assess non-inferiority of the short, flare-up GnRH-agonist protocol compared to the GnRH-antagonist protocol, both with OC pill pre-treatment, in patients treated with IVF/ICSI for subfertility, with respect to:
1. Premature urinary LH surges;
2. Follicular development;
3. Number of oocytes and (top-quality) embryos;
4. Embryo metabolomics;
5. Endometrial thickness;
6. Hormone levels: LH, FSH, oestradiol, progesterone;
7. (Signs of) OHSS;
8. Cancellation rate;
9. Fertilisation rate, implantation rate, ongoing pregnancy rate and live birth rate;
10. (Hypo-oestrogenic) adverse events;
11. Total dose and duration of GnRH analogue and gonadotrophin treatment.
- TimepointsThe primary endpoint is the incidence of premature LH surges, defined as a serum LH value > 10 IU/l, with or without a rise in progesterone, defined as a value > 1 ng/ml (> 3.18 nmol/l).
Secondary endpoints include incidence of premature urine LH surges, follicular development, number of oocytes and (top-quality) embryo’s, embryo metabolomics, endometrial thickness, hormone levels (LH, FSH, oestradiol, progesterone), (signs of) ovarian hyperstimulation syndrome (OHSS), cancellation rate, fertilisation rate, implantation rate, ongoing pregnancy rate and live birth rate. In addition, (hypo-oestrogenic) adverse events and total dose and duration of GnRH analogue and gonadotrophin treatment will be assessed.
- Trial web siteN/A
- statusstopped
- CONTACT FOR PUBLIC QUERIESDr. P.G.A. Hompes
- CONTACT for SCIENTIFIC QUERIESDr. P.G.A. Hompes
- Sponsor/Initiator VU University Medical Center, Department of Obstetrics and Gynaecology
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center, Department of Obstetrics and Gynaecology
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)26-Apr-2013: Trial has ended prematurely due to a inclusion shortage - NM
- RECORD16-feb-2011 - 26-apr-2013


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl