Premature Luteinisation, Progesterone Elevation
Conditions
Keywords
Controlled ovarian stimulation, GnRH antagonist, oocyte donation, LH surge
Brief summary
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.
Detailed description
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.
Interventions
OTHERGnRH 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.
Sponsors
Faculty of Medicine, School of Health Sciences, University of Thessaly, Larissa, Greece
Embryoland, Athens, Greece
Embryolab IVF Unit, Thessaloniki, Greece
Assisting Nature IVF Unit, Thessaloniki, Greece
HYGEIA IVF - Embryogenesis A.R.T. Unit, Athens, Greece
Institute of Fertility, Athens, Greece
Mitosis IVF Centre, Pireas, Greece
National and Kapodistrian University of Athens
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 32 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy women 21-32 years old with a BMI of 21 to 29 kg/m2 who wish to donate their oocytes * normal ovarian reserve tests * normal menstrual cycles of 26-32 days * the women would not have received any hormonal treatment during the last three months before entering the study. * absence of coagulation and/or autoimmune disorders.
Exclusion criteria
1. Use of other protocols towards oocyte retrieval, such as natural, or modified natural cycles 2. Poor ovarian response according to the Bologna criteria \[22\], 3. History of endocrine or metabolic disorders, ovarian cystectomy or oophorectomy, 4. Women with the diagnosis of polycystic ovary syndrome 5. Clinical and/or laboratory markers of hereditary or acquired thrombophilia that complied to the standard protocols of each Unit. * Non-hormonal medication for a serious medical condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of LH secretory peaks | 3 weeks after start of ovarian stimulation. | A secretory peak of LH is defined as the increase at levels ≥10 IU/l. |
| Rate of concentration of progesterone >1 ng/ml | At any time within 3 weeks after start of ovarian stimulation. | Concentration of progesterone elevation \>1 ng/ml |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of ongoing clinical pregnancy | 12 weeks after last menstrual period | Clinical pregnancy (fetal heart beat) at ultrasound |
| Rate of miscarriage | Within 20 weeks after last menstrual period | Miscarriage / Loss of the embryo |
Other
| Measure | Time frame | Description |
|---|---|---|
| Total dose of gonadotrophins (rFSH) | 2 weeks after last menstrual period | Dose of rFSH administered |
| Number of retrieved cumulus oocytes complexes (COCs) | 3 weeks after last menstrual period / and start of ovarian stimulation | Number of retrieved cumulus oocytes complexes (COCs) at oocyte retrieval |
Contacts
Primary ContactIoannis Messinis, Prof
Backup ContactCharalampos Siristatidis, Prof
Outcome results
None listed