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TOPFIT: Triptorelin Oral contraceptive Pill Flare-up in IVF/ICSI Treatment trial The effect of a short, flare-up gonadotrophin-releasing hormone agonist versus antagonist treatment protocol in patients pre-treated with oral contraceptive pill on premature luteinizing hormone surges

TOPFIT: Triptorelin Oral contraceptive Pill Flare-up in IVF/ICSI Treatment trial The effect of a short, flare-up gonadotrophin-releasing hormone agonist versus antagonist treatment protocol in patients pre-treated with oral contraceptive pill on premature luteinizing hormone surges - TOPFIT-trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON34327
Enrollment
200
Registered
2010-09-21
Start date
2011-01-01
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

infertility IVF/ICSI treatment

Interventions

1. 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 cycl

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - IVF or ICSI treatment (first, second or third cycle) - Signed informed consent

Exclusion criteria

Exclusion criteria: - Women aged over 39 years - Women with a single ovary - Known poor responders, defined as women with a follicle count of 14 mm in a previous IVF/ICSI treatment cycle - History or evidence of polycystic ovary syndrome (PCOS) or incipient ovarian failure (IOF) - Severe endometriosis, stage III/IV, needing Surrey stimulation protocol - Women with known contraindications for oral OCs

Design outcomes

Primary

MeasureTime frame
The 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

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)