Infertility Clinical Trial
— COMPORTOfficial title:
Corifollitropin Alfa Followed by Hp-HMG Versus Recombinant FSH in Young Poor Ovarian Responders. A Multicentre Randomized Controlled Clinical Trial
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.
Status | Completed |
Enrollment | 150 |
Est. completion date | May 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 39 Years |
Eligibility |
Inclusion Criteria: - Age less than 40 years - Fulfillment of the "Bologna criteria" for poor ovarian response. Based on inclusion criteria two patients' categories are eligible: 1. Women < 40 years old AND =3 oocytes in one of the previous cycles AND (Antral follicle count <7 or antimullerian hormone serum values <1.1 ng/ml) 2. Women <40 years old and =3 oocytes in two the previous cycles with maximum ovarian stimulation 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: - Uterine abnormalities - Recent history of any current untreated endocrine abnormality - Unilateral or bilateral hydrosalpinx (visible on transvaginal ultrasound, unless clipped) - Contraindications for the use of gonadotropins - Recent history of severe disease requiring regular treatment |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | Universitair Ziekenhuis Brussel | Brussels | |
Vietnam | University of Medicine and Pharmacy of Ho Chi Minh City | Ho Chi Minh City |
Lead Sponsor | Collaborator |
---|---|
Universitair Ziekenhuis Brussel | Ho Chi Minh City University of Medicine and Pharmacy |
Belgium, Vietnam,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Cycle cancellation due to poor ovarian response | Number of cycles cancelled due to monofollicular or no follicular development | Day 8-10 of ovarian stimulation | No |
Other | Number of cycles reaching the stage of embryo transfer | The outcome will be evaluated 3 days after oocyte retrieval | 9 -20 days from initiation of ovarian stimulation | No |
Other | Number and quality of embryos | 3 days after oocyte retrieval | Day of embryo transfer | No |
Other | 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 | No |
Other | Endocrine parameters (LH,FSH, E2, Progesterone) during ovarian stimulation | Days 1,6,8,10 of stimulation and day of ovulation triggering | No | |
Other | 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 | Yes |
Primary | 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 | No |
Secondary | Clinical pregnancy | The presence of intrauterine gestational sac at 7 weeks of gestation | 7 weeks of gestation | No |
Secondary | Biochemical pregnancy | Positive pregnancy test 2 weeks after embryo transfer | 2 weeks after embryo transfer | No |
Secondary | Number of oocytes retrieved | The outcome will be evaluated on the day of oocyte retrieval | 9 -20 days from initiation of ovarian stimulation | No |
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