LH surge, ovulation, sub-fertility, GnRH-agonist, GnRH-antagonist
Conditions
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 cycle,
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 st
Sponsors
VU University Medical Center, Department of Obstetrics and Gynaecology
Eligibility
Inclusion criteria
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
Exclusion criteria: 1. Women aged over 39 years; 2. Women with a single ovary; 3. Known poor responders, defined as women with a follicle count of 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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: 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. | — |
Contacts
Public ContactP.G.A. Hompes
P.O. Box 7057
Outcome results
None listed