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| Name | Class |
|---|---|
| Faculty of Medicine, School of Health Sciences, University of Thessaly, Larissa, Greece | UNKNOWN |
| Embryoland, Athens, Greece | UNKNOWN |
| Embryolab IVF Unit, Thessaloniki, Greece | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FSH only (no GnRH antagonist) | Experimental | 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. |
|
| FSH + GnRH antagonist | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GnRH antagonist | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of LH secretory peaks | A secretory peak of LH is defined as the increase at levels ≥10 IU/l. | 3 weeks after start of ovarian stimulation. |
| Rate of concentration of progesterone >1 ng/ml | Concentration of progesterone elevation >1 ng/ml | At any time within 3 weeks after start of ovarian stimulation. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of ongoing clinical pregnancy | Clinical pregnancy (fetal heart beat) at ultrasound | 12 weeks after last menstrual period |
| Rate of miscarriage | Miscarriage / Loss of the embryo |
| Measure | Description | Time Frame |
|---|---|---|
| Total dose of gonadotrophins (rFSH) | Dose of rFSH administered | 2 weeks after last menstrual period |
| Number of retrieved cumulus oocytes complexes (COCs) | Number of retrieved cumulus oocytes complexes (COCs) at oocyte retrieval |
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.
Exclusion Criteria:
Use of other protocols towards oocyte retrieval, such as natural, or modified natural cycles
Poor ovarian response according to the Bologna criteria [22],
History of endocrine or metabolic disorders, ovarian cystectomy or oophorectomy,
Women with the diagnosis of polycystic ovary syndrome
Clinical and/or laboratory markers of hereditary or acquired thrombophilia that complied to the standard protocols of each Unit.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ioannis Messinis, Prof | Contact | 6944370627 | 0030 | messinis.io@gmail.com |
| Charalampos Siristatidis, Prof | Contact | 2107286306 | 0030 | harrysiri@yahoo.gr |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27100388 | Background | Wang HL, Lai HH, Chuang TH, Shih YW, Huang SC, Lee MJ, Chen SU. A Patient Friendly Corifollitropin Alfa Protocol without Routine Pituitary Suppression in Normal Responders. PLoS One. 2016 Apr 21;11(4):e0154123. doi: 10.1371/journal.pone.0154123. eCollection 2016. | |
| 37370146 | Background | Zhang Y, Xu Y, Yu J, Wang X, Xue Q, Shang J, Yang X, Shan X. A premature luteinizing hormone surge without elevated progesterone levels has no adverse effect on cumulative live birth rate in patient undergoing a flexible GnRH antagonist protocol: a retrospective study. J Ovarian Res. 2023 Jun 27;16(1):119. doi: 10.1186/s13048-023-01219-w. |
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| ID | Term |
|---|---|
| C092464 | LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)- |
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| Assisting Nature IVF Unit, Thessaloniki, Greece | UNKNOWN |
| HYGEIA IVF - Embryogenesis A.R.T. Unit, Athens, Greece | UNKNOWN |
| Institute of Fertility, Athens, Greece | UNKNOWN |
| Mitosis IVF Centre, Pireas, Greece | UNKNOWN |
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.
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| Within 20 weeks after last menstrual period |
| 3 weeks after last menstrual period / and start of ovarian stimulation |
| 25956370 | Background | Kuang Y, Chen Q, Fu Y, Wang Y, Hong Q, Lyu Q, Ai A, Shoham Z. Medroxyprogesterone acetate is an effective oral alternative for preventing premature luteinizing hormone surges in women undergoing controlled ovarian hyperstimulation for in vitro fertilization. Fertil Steril. 2015 Jul;104(1):62-70.e3. doi: 10.1016/j.fertnstert.2015.03.022. Epub 2015 May 5. |
| 33583700 | Background | Messinis IE, Messini CI, Anifandis G, Daponte A. Exogenous progesterone for LH surge prevention is redundant in ovarian stimulation protocols. Reprod Biomed Online. 2021 Apr;42(4):694-697. doi: 10.1016/j.rbmo.2021.01.017. Epub 2021 Jan 30. |
| 3085995 | Background | Messinis IE, Templeton A, Baird DT. Endogenous luteinizing hormone surge in women during induction of multiple follicular development with pulsatile follicle stimulating hormone. Clin Endocrinol (Oxf). 1986 Feb;24(2):193-201. doi: 10.1111/j.1365-2265.1986.tb00762.x. |