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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000583-29 | EudraCT Number |
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| Name | Class |
|---|---|
| University of Medicine and Pharmacy at Ho Chi Minh City | OTHER |
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In combination with the existing literature, previous work indicates that 1) women with poor ovarian response fulfilling the "Bologna criteria" have very low pregnancy rates, irrespective of age 2) current treatment protocols demonstrate ongoing pregnancy rates that do not exceed 8.5% and 3) corifollitropin alfa followed by hpHMG might increase ongoing pregnancy rates in young patients (<40years old) fulfilling the criteria. These findings provide a strong rationale for a definitive large RCT. The COMPORT study will provide conclusive evidence regarding the superiority or not of this novel protocol with corifollitropin alfa followed by hpHMG for the treatment of young poor ovarian responders fulfilling the Bologna criteria.
Recently, the European Society of Human Reproduction and Embryology developed a new definition in order to select patients suitable for inclusion in future clinical trials as poor ovarian responders, the so-called "Bologna criteria". However, a limited number of studies has been published to date including patients with poor ovarian response according to the "Bologna criteria", whereas no randomized trial is published or ongoing for this population.
Preliminary reports in "Bologna poor responders" highlight the limited prospects for these women. Natural cycle IVF has been shown to result in disappointingly low live birth rates, regardless of patients' age and ovarian stimulation with widely accepted treatment modalities, e.g. short agonist protocol, did not appear demonstrate substantial benefits.
Nonetheless, despite the disappointing results from the vast majority of the preliminary studies in this population, a recent pilot study by our group has shown that a specific protocol may indeed be a promising option for women of younger age fulfilling the "Bologna criteria". Corifollitropin alfa followed by highly purified hMG in an antagonist protocol demonstrated an ongoing pregnancy rate of 28% in women <40years, strongly suggesting the conduction of a future randomized trial testing this novel treatment protocol
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corifollitropin alfa followed by hpHMG | Experimental |
| |
| recombinant FSH | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corifollitropin alfa | Drug | Corifollitropin alfa 150μg on day 2 of the menstrual cycle (stimulation day 1) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ongoing pregnancy | The presence of intrauterine gestational sac with an embryonic pole demonstrating cardiac activity at 9-10 weeks of gestation. | 9-10 weeks of gestation |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical pregnancy | The presence of intrauterine gestational sac at 7 weeks of gestation | 7 weeks of gestation |
| Biochemical pregnancy | Positive pregnancy test 2 weeks after embryo transfer |
| Measure | Description | Time Frame |
|---|---|---|
| Cycle cancellation due to poor ovarian response | Number of cycles cancelled due to monofollicular or no follicular development | Day 8-10 of ovarian stimulation |
| Number of cycles reaching the stage of embryo transfer |
Inclusion Criteria:
Based on inclusion criteria two patients' categories are eligible:
In addition women less than 40 years old will be considered eligible if they had undergone previous ovarian surgery or chemotherapy (risk factors for poor ovarian response) and have an AMH<1.1ng/ml or an AFC<7, as suggested by the Bologna criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nikolaos P Polyzos, MD PhD | Universitair Ziekenhuis Brussel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Brussel | Brussels | 1090 | Belgium | |||
| University of Medicine and Pharmacy of Ho Chi Minh City |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23442756 | Background | Polyzos NP, De Vos M, Corona R, Vloeberghs V, Ortega-Hrepich C, Stoop D, Tournaye H. Addition of highly purified HMG after corifollitropin alfa in antagonist-treated poor ovarian responders: a pilot study. Hum Reprod. 2013 May;28(5):1254-60. doi: 10.1093/humrep/det045. Epub 2013 Feb 26. | |
| 23084565 | Background |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C437186 | follicle stimulating hormone, human, with HCG C-terminal peptide |
| C061018 | ganirelix |
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| recombinant FSH | Drug | recombinant FSH 300IU/daily from day 2 of the cycle (stimulation day 8)until day of ovulation triggering |
|
| Ganirelix | Drug | Ganirelix 0.25mg/daily from day 7 of the cycle(stimulation day 6) until day of ovulation triggering |
|
| hp HMG | Drug | hp HMG 300IU/daily from day 9 of the cycle (stimulation day 8)until day of ovulation triggering |
|
| 2 weeks after embryo transfer |
| Number of oocytes retrieved | The outcome will be evaluated on the day of oocyte retrieval | 9 -20 days from initiation of ovarian stimulation |
The outcome will be evaluated 3 days after oocyte retrieval
| 9 -20 days from initiation of ovarian stimulation |
| Number and quality of embryos | 3 days after oocyte retrieval | Day of embryo transfer |
| Number of cycles with frozen supernumerary embryos | The outcome will be evaluated 5 days after oocyte retrieval or 2-3 days after embryo transfer in case of an embryo transfer | 9 -20 days from initiation of ovarian stimulation |
| Endocrine parameters (LH,FSH, E2, Progesterone) during ovarian stimulation | Days 1,6,8,10 of stimulation and day of ovulation triggering |
| Cycle cancellation due to serious adverse effects of medication | 20-25 days after the initiation of ovarian stimulation all patients (cycles) will be monitored for the occurence of any adverse effect and cycle cancellation(during ovarian stimulation) due to a serious adverse effect from medication | 20-25 days after initiation of stimulation |
| Ho Chi Minh City |
| Vietnam |
| Polyzos NP, Devos M, Humaidan P, Stoop D, Ortega-Hrepich C, Devroey P, Tournaye H. Corifollitropin alfa followed by rFSH in a GnRH antagonist protocol for poor ovarian responder patients: an observational pilot study. Fertil Steril. 2013 Feb;99(2):422-6. doi: 10.1016/j.fertnstert.2012.09.043. Epub 2012 Oct 16. |
| 22940767 | Background | Polyzos NP, Blockeel C, Verpoest W, De Vos M, Stoop D, Vloeberghs V, Camus M, Devroey P, Tournaye H. Live birth rates following natural cycle IVF in women with poor ovarian response according to the Bologna criteria. Hum Reprod. 2012 Dec;27(12):3481-6. doi: 10.1093/humrep/des318. Epub 2012 Aug 30. |
| 22036048 | Background | Polyzos NP, Devroey P. A systematic review of randomized trials for the treatment of poor ovarian responders: is there any light at the end of the tunnel? Fertil Steril. 2011 Nov;96(5):1058-61.e7. doi: 10.1016/j.fertnstert.2011.09.048. |
| 21505041 | Background | Ferraretti AP, La Marca A, Fauser BC, Tarlatzis B, Nargund G, Gianaroli L; ESHRE working group on Poor Ovarian Response Definition. ESHRE consensus on the definition of 'poor response' to ovarian stimulation for in vitro fertilization: the Bologna criteria. Hum Reprod. 2011 Jul;26(7):1616-24. doi: 10.1093/humrep/der092. Epub 2011 Apr 19. |
| 29040589 | Derived | Drakopoulos P, Vuong TNL, Ho NAV, Vaiarelli A, Ho MT, Blockeel C, Camus M, Lam AT, van de Vijver A, Humaidan P, Tournaye H, Polyzos NP. Corifollitropin alfa followed by highly purified HMG versus recombinant FSH in young poor ovarian responders: a multicentre randomized controlled clinical trial. Hum Reprod. 2017 Nov 1;32(11):2225-2233. doi: 10.1093/humrep/dex296. |