Triptorelin Oral contraceptive Pill Flare-up in IVF/ICSI Treatment trial.
Suspended
- Conditions
- H surge, ovulation, sub-fertility, GnRH-agonist, GnRH-antagonist
- Registration Number
- NL-OMON29309
- Lead Sponsor
- VU University Medical Center, Department of Obstetrics and Gynaecology
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
Any 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 Criteria
1. Women aged over 39 years;
2. Women with a single ovary;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To 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 Outcome Measures
Name Time Method To 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:<br /><br>1. Premature urinary LH surges;<br /><br>2. Follicular development;<br /><br>3. Number of oocytes and (top-quality) embryos;<br /><br>4. Embryo metabolomics;<br /><br>5. Endometrial thickness;<br /><br>6. Hormone levels: LH, FSH, oestradiol, progesterone;<br /><br>7. (Signs of) OHSS;<br /><br>8. Cancellation rate;<br /><br>9. Fertilisation rate, implantation rate, ongoing pregnancy rate and live birth rate;<br /><br>10. (Hypo-oestrogenic) adverse events;<br /><br>11. Total dose and duration of GnRH analogue and gonadotrophin treatment.