A Phase 1/2 interventional study of GnRH antagonist in Premature Luteinisation and Progesterone Elevation, sponsored by National and Kapodistrian University of Athens. Status unknown. Open to female participants aged 21 Years to 32 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-10.
Sponsored by National and Kapodistrian University of Athens · Phase 1/2, Interventional, and Treatment
The aim of this study is to compare the efficacy of a protocol using FSH alone with that of a protocol using FSH plus a GnRH antagonist for controlled ovarian hyperstimulation in cycles of elective freezing in the context of a donor/recipient programme.
The hypothesis to be tested is that an ovarian stimulation protocol that includes FSH alone without any LH surge prevention regimens is not inferior to a protocol including FSH plus a GnRH antagonist in terms of clinical outcome in a donor/recipient model.
The formal sample size is calculated as follows:
If there is a true difference in favour of the experimental treatment of 5% (20% vs 15%), then 160 patients (80 per group in case of 1:1 enrolment) are required to be 80% sure that the upper limit of a one-sided 95% confidence interval (or equivalently a 90% two-sided confidence interval) will exclude a difference in favour of the standard/control group of more than 10%.
In the context of the present pilot study (as a first stage), the investigators intend to study 50 patients (25 per group in case of 1:1 enrolment). At a second stage the above mentioned sample size will be used.
National and Kapodistrian University of Athens is the lead sponsor of 168 studies on the registry; 50 are open to participants now.
Counted across the registry records on this site, refreshed daily.
the women would not have received any hormonal treatment during the last three months before entering the study.
Exclusion Criteria:
Clinical and/or laboratory markers of hereditary or acquired thrombophilia that complied to the standard protocols of each Unit.
Women receive only FSH starting on day 2 of the cycle. The starting dose of FSH is 225-300 IU s.c. for the first 4 days adjusted thereafter according to the ovarian response.
Other: GnRH antagonist
Women receive 225-300 IU s.c. FSH, and a GnRH antagonist from day 6 of FSH treatment at the dose of 0.25 mg per day until the triggering day. The GnRH antagonist in group 2 is injected each time immediately after the injection of FSH.
Other: GnRH antagonist
The GnRH antagonist in the control group (standard therapy) is administered from day 6 of FSH treatment at the dose of 0.25 mg per day until the triggering day and is injected each time immediately after the injection of FSH.
Rate of LH secretory peaks
A secretory peak of LH is defined as the increase at levels ≥10 IU/l.
Time frame: 3 weeks after start of ovarian stimulation.
Rate of concentration of progesterone >1 ng/ml
Concentration of progesterone elevation \>1 ng/ml
Time frame: At any time within 3 weeks after start of ovarian stimulation.
Rate of ongoing clinical pregnancy
Clinical pregnancy (fetal heart beat) at ultrasound
Time frame: 12 weeks after last menstrual period
Rate of miscarriage
Miscarriage / Loss of the embryo
Time frame: Within 20 weeks after last menstrual period
Total dose of gonadotrophins (rFSH)
Dose of rFSH administered
Time frame: 2 weeks after last menstrual period
Number of retrieved cumulus oocytes complexes (COCs)
Number of retrieved cumulus oocytes complexes (COCs) at oocyte retrieval
Time frame: 3 weeks after last menstrual period / and start of ovarian stimulation
No study locations are listed for this record.
Plan to share: Undecided
This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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National and Kapodistrian University of Athens