Effect of Treatment With Corifollitropin Alpha in Vitro Fertilization in Patients With Poor Ovarian Response.
NCT ID: NCT02118051
Last Updated: 2017-06-12
Study Results
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Basic Information
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COMPLETED
PHASE3
234 participants
INTERVENTIONAL
2013-09-30
2017-06-30
Brief Summary
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In this study aims to demonstrate non-inferiority of the Corifollitropin Alpha (CFA ) versus daily administration of Human Menopausal Gonadotropin (hMG) (Menopur ®) during the first seven days of ovarian stimulation, in a protocol with gonadotropin-releasing hormone ( GnRH) antagonists
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Detailed Description
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The ovarian response to gonadotropin stimulation is crucial for successful assisted reproduction techniques .Cycles with low rates response was obtained and increased cancellation rate and worst pregnancy rates .
Different criteria for the definition of low response, different tests to assess ovarian reserve and different threshold values for each has been used.
In 2010 a group of experts from the ESHRE ,achieved consensus on the criteria for low ovarian response to homogenize the study groups and reach meaningful conclusions, are known as "The Bologna criteria" ,they defined the "Poor Ovarian Response" (POR).
There is not sufficient to recommend most of the proposed treatments to improve pregnancy rates in poor responders evidence.
Taking into account the profile of equivalence and safety of CFA (Corifollitropin Alpha , active of ELONVA ® ) , different studies had been concluded that CFA can be an alternative to daily injections of recombinant follicle stimulating hormone ( rFSH) in normal responders patients in vitro fertilization cycle with ovarian stimulation.But more research is needed to determine whether long-acting recombinant follicle stimulating hormone ( rFSH) is safe and effective for use in women with low and high response.
The ovarian controlled stimulation with Alpha Corifollitropin produces significantly more oocytes compared to recombinant follicle stimulating hormone (r FSH ) administrated daily in normal responders patients, For this reason , the use of Alpha Corifollitropin may be beneficial in patients with poor response which the number of oocytes retrieved is crucial for successful treatment
There have been two studies in which the results are compared after ovarian stimulation with daily rFSH vs CFA . In both shows , retrospectively and prospectively , the CFA seems to be at least as effective as hMG recombinant follicle stimulating hormone ( rFSH) daily.
There are scientific publications showing that the association of luteinizing hormone ( LH) to recombinant follicle stimulating hormone ( rFSH) can improve embryos quality and achieved better pregnancy rate . The pregnancy rate was not statistically significant , in normal responders patients.
Recently reported the beneficial effect in POR patients treated with CFA and hMG.
The IVF treatment is known to affects the physical and mental condition in patients with infertility , being the excess emotional stress one of the most important reasons for discontinuation of treatment.
The ovarian stimulation with CFA simplifies treatment , reducing the administration of multiple daily injections ,and may reduce the emotional burden on patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CFA , hMG,Ganirelix,choriogonadotropin alfa,progesterone.
Corifollitropin Alfa (CFA) 150 ug from the 2nd day of the cycle for 7 days. hMG 300 IU/24h, if required from the 8th day of the Controlled Ovarian Stimulation , until the day human chorionic gonadotropin ( hCG.) Ganirelix 0.25 mg,Dose: 250μg/24h since the day observe a follicle\> 14mm. Recombinant choriogonadotropin alfa,Dose: 6,500 IU, pods, when follicles\> 17 mm are observed.
Micronized natural progesterone. Route of administration: vaginal. Dose: 400mg/24, from embryo transfer until the day of b-hCG.
Ganirelix 0.25 mg.
Ganirelix 0.25 mg. Route of administration: Subcutaneous use. Dose: 250μg/24h since the day observe a follicle\> 14mm.
Recombinant choriogonadotropin alfa
Recombinant choriogonadotropin alfa. Route of administration: Subcutaneous use. Dose: 6,500 IU, pods, when follicles\> 17 mm are observed
Micronized natural progesterone.
Micronized natural progesterone. Route of administration: vaginal . Dose: 400mg/24, from embryo transfer until the day of b-hCG.
hMG ,Ganirelix,choriogonadotropin alfa,progesterone
Human Menopausal Gonadotropin (hMG). Dose: 300 IU/24h from the 2nd day of the cycle throughout the stimulation.
Ganirelix 0.25 mg,Dose: 250μg/24h since the day observe a follicle\> 14mm. Recombinant choriogonadotropin alfa,Dose: 6,500 IU, pods, when follicles\> 17 mm are observed.
Micronized natural progesterone. Route of administration: vaginal. Dose: 400mg/24, from embryo transfer until the day of b-hCG.
Ganirelix 0.25 mg.
Ganirelix 0.25 mg. Route of administration: Subcutaneous use. Dose: 250μg/24h since the day observe a follicle\> 14mm.
Recombinant choriogonadotropin alfa
Recombinant choriogonadotropin alfa. Route of administration: Subcutaneous use. Dose: 6,500 IU, pods, when follicles\> 17 mm are observed
Micronized natural progesterone.
Micronized natural progesterone. Route of administration: vaginal . Dose: 400mg/24, from embryo transfer until the day of b-hCG.
Interventions
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Ganirelix 0.25 mg.
Ganirelix 0.25 mg. Route of administration: Subcutaneous use. Dose: 250μg/24h since the day observe a follicle\> 14mm.
Recombinant choriogonadotropin alfa
Recombinant choriogonadotropin alfa. Route of administration: Subcutaneous use. Dose: 6,500 IU, pods, when follicles\> 17 mm are observed
Micronized natural progesterone.
Micronized natural progesterone. Route of administration: vaginal . Dose: 400mg/24, from embryo transfer until the day of b-hCG.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. \- Signed informed consent to perform IVF and participation in this study.
3. \- Due to characteristics of our center not perform treatments in patients
* 40 years old ,and being one of the Bologna criteria that we will not be able to consider ,we decided to include patients affected subsidiary infertility treatment by IVF or intracytoplasmatic sperm injection (ICSI), present one of the following factors
1. Have a history of surgical or medical treatment as a risk factor for POR.
2. Patients witch had have a poor ovarian response in response to the ovarian controlled stimulation (previous cycle after conventional stimulation with ≤ 3 oocytes)
3. Patients with ovarian reserve test anti-mullerian hormone(AMH ) \<1.1 ng / ml (\<8 pM) or antral follicle count (AFC)\<7
Exclusion Criteria
2. -Patient with tubal factor, untreated
3. -Patient with uterine pathology untreated
4. \- Couples with severe male factor, fresh count \<5 million / ml, and azoospermia in which the patient's sperm, epididymal or testicular is used
18 Years
40 Years
FEMALE
No
Sponsors
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Instituto de Investigacion Sanitaria La Fe
OTHER
Responsible Party
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Principal Investigators
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Roser Taroncher
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario La Fe
Locations
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Human Reproduction Unit of the La Fe University and Politechnic Hospital
Valencia, , Spain
Countries
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References
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Cousineau TM, Domar AD. Psychological impact of infertility. Best Pract Res Clin Obstet Gynaecol. 2007 Apr;21(2):293-308. doi: 10.1016/j.bpobgyn.2006.12.003. Epub 2007 Jan 22.
Devroey P, Boostanfar R, Koper NP, Mannaerts BM, Ijzerman-Boon PC, Fauser BC; ENGAGE Investigators. A double-blind, non-inferiority RCT comparing corifollitropin alfa and recombinant FSH during the first seven days of ovarian stimulation using a GnRH antagonist protocol. Hum Reprod. 2009 Dec;24(12):3063-72. doi: 10.1093/humrep/dep291. Epub 2009 Aug 14.
Devroey P, Fauser BC, Platteau P, Beckers NG, Dhont M, Mannaerts BM. Induction of multiple follicular development by a single dose of long-acting recombinant follicle-Stimulating hormone (FSH-CTP, corifollitropin alfa) for controlled ovarian stimulation before in vitro fertilization. J Clin Endocrinol Metab. 2004 May;89(5):2062-70. doi: 10.1210/jc.2003-031766.
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.
Keay SD, Liversedge NH, Mathur RS, Jenkins JM. Assisted conception following poor ovarian response to gonadotrophin stimulation. Br J Obstet Gynaecol. 1997 May;104(5):521-7. doi: 10.1111/j.1471-0528.1997.tb11525.x. No abstract available.
Kim CH, Jeon GH, Cheon YP, Jeon I, Kim SH, Chae HD, Kang BM. Comparison of GnRH antagonist protocol with or without oral contraceptive pill pretreatment and GnRH agonist low-dose long protocol in low responders undergoing IVF/intracytoplasmic sperm injection. Fertil Steril. 2009 Nov;92(5):1758-60. doi: 10.1016/j.fertnstert.2009.05.013. Epub 2009 Jun 12.
Kolibianakis EM, Venetis CA, Bosdou JK, Zepiridis L, Chatzimeletiou K, Makedos A, Masouridou S, Triantafillidis S, Mitsoli A, Tarlatzis BC. Corifollitropin alfa compared with follitropin beta in poor responders undergoing ICSI: a randomized controlled trial. Hum Reprod. 2015 Feb;30(2):432-40. doi: 10.1093/humrep/deu301. Epub 2014 Dec 9.
Kyrou D, Kolibianakis EM, Venetis CA, Papanikolaou EG, Bontis J, Tarlatzis BC. How to improve the probability of pregnancy in poor responders undergoing in vitro fertilization: a systematic review and meta-analysis. Fertil Steril. 2009 Mar;91(3):749-66. doi: 10.1016/j.fertnstert.2007.12.077. Epub 2008 Jul 21.
Mahmoud Youssef MA, van Wely M, Aboulfoutouh I, El-Khyat W, van der Veen F, Al-Inany H. Is there a place for corifollitropin alfa in IVF/ICSI cycles? A systematic review and meta-analysis. Fertil Steril. 2012 Apr;97(4):876-85. doi: 10.1016/j.fertnstert.2012.01.092. Epub 2012 Jan 23.
Pandian Z, McTavish AR, Aucott L, Hamilton MP, Bhattacharya S. Interventions for 'poor responders' to controlled ovarian hyper stimulation (COH) in in-vitro fertilisation (IVF). Cochrane Database Syst Rev. 2010 Jan 20;(1):CD004379. doi: 10.1002/14651858.CD004379.pub3.
Pellicer A, Lightman A, Diamond MP, Russell JB, DeCherney AH. Outcome of in vitro fertilization in women with low response to ovarian stimulation. Fertil Steril. 1987 May;47(5):812-5. doi: 10.1016/s0015-0282(16)59170-5.
Pellicer A, Ardiles G, Neuspiller F, Remohi J, Simon C, Bonilla-Musoles F. Evaluation of the ovarian reserve in young low responders with normal basal levels of follicle-stimulating hormone using three-dimensional ultrasonography. Fertil Steril. 1998 Oct;70(4):671-5. doi: 10.1016/s0015-0282(98)00268-4.
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.
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.
Pouwer AW, Farquhar C, Kremer JA. Long-acting FSH versus daily FSH for women undergoing assisted reproduction. Cochrane Database Syst Rev. 2012 Jun 13;(6):CD009577. doi: 10.1002/14651858.CD009577.pub2.
Requena A, Landeras JL, Martinez-Navarro L, Calatayud C, Sanchez F, Maldonado V, Munoz M, Fernandez M, Gonzalez A, Lopez S, Lopez R, Pacheco A, Calderon G, Martinez V. Could the addition of hp-hMG and GnRH antagonists modulate the response in IVF-ICSI cycles? Hum Fertil (Camb). 2010 Mar;13(1):41-9. doi: 10.3109/14647270903586356.
Tarlatzis BC, Zepiridis L, Grimbizis G, Bontis J. Clinical management of low ovarian response to stimulation for IVF: a systematic review. Hum Reprod Update. 2003 Jan-Feb;9(1):61-76. doi: 10.1093/humupd/dmg007.
Other Identifiers
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2013-002027-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
POR-ELONVA
Identifier Type: -
Identifier Source: org_study_id
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