Effect of Treatment With Corifollitropin Alpha in Vitro Fertilization in Patients With Poor Ovarian Response.

NCT02118051 | Completed Phase 3 DMC

• 2 other identifiers: POR-ELONVA2013-002027-42
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

Brief Summary

Patients who have had or are expected to have a poor ovarian response (POR), because they meet any of the criteria of Bologna, can benefit from ovarian stimulation with 150 mg of alpha Corifollitropin (CFA) (Elonva ®) as single dose for a week, in the cycles of in vitro fertilization (IVF). 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

Conditions

Infertility

Keywords

Infertility; IVF; Corifollitropin Alfa treatment; Ovarian stimulation

Outcome Measures

Primary Outcomes (2)

• Rate of evolutionary gestation in each cycle

  Evolutionary pregnancy has been defined as gestation of at least 1 fetus reaches 20 weeks of gestation diagnosed by normal ultrasound or confirmed by live birth

  20 week of gestation

• oocytes (MII) rate by patient

  When follicular puncture occurs, we value the number of punctured follicles, total oocytes and MII oocytes

  participants will be followed for the duration of the cycle,an expected average of 8-16 days.

Secondary Outcomes (1)

• Number of Participants with Adverse Events

  participants will be followed for the duration of the cycle,an expected average of 16 days.

Study Arms (2)

CFA , hMG,Ganirelix,choriogonadotropin alfa,progesterone.

EXPERIMENTAL

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.

Drug: Ganirelix 0.25 mg.; Drug: Recombinant choriogonadotropin alfa; Drug: Micronized natural progesterone.

hMG ,Ganirelix,choriogonadotropin alfa,progesterone

ACTIVE COMPARATOR

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.

Drug: Ganirelix 0.25 mg.; Drug: Recombinant choriogonadotropin alfa; Drug: Micronized natural progesterone.

Interventions

Ganirelix 0.25 mg. DRUG

Ganirelix 0.25 mg. Route of administration: Subcutaneous use. Dose: 250μg/24h since the day observe a follicle\> 14mm.

Also known as: ORGALUTRAN®.

CFA , hMG,Ganirelix,choriogonadotropin alfa,progesterone.; hMG ,Ganirelix,choriogonadotropin alfa,progesterone

Recombinant choriogonadotropin alfa DRUG

Recombinant choriogonadotropin alfa. Route of administration: Subcutaneous use. Dose: 6,500 IU, pods, when follicles\> 17 mm are observed

Also known as: OVITRELLE®.

CFA , hMG,Ganirelix,choriogonadotropin alfa,progesterone.; hMG ,Ganirelix,choriogonadotropin alfa,progesterone

Micronized natural progesterone. DRUG

Micronized natural progesterone. Route of administration: vaginal . Dose: 400mg/24, from embryo transfer until the day of b-hCG.

Also known as: PROGEFFIK®.

CFA , hMG,Ganirelix,choriogonadotropin alfa,progesterone.; hMG ,Ganirelix,choriogonadotropin alfa,progesterone

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- Age ≥ 18 years old.
• \- Signed informed consent to perform IVF and participation in this study.
• \- Due to characteristics of our center not perform treatments in patients
• 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
• Have a history of surgical or medical treatment as a risk factor for POR.
• Patients witch had have a poor ovarian response in response to the ovarian controlled stimulation (previous cycle after conventional stimulation with ≤ 3 oocytes)
• Patients with ovarian reserve test anti-mullerian hormone(AMH ) \<1.1 ng / ml (\<8 pM) or antral follicle count (AFC)\<7

You may not qualify if:

• Anovulation.
• Patient with tubal factor, untreated
• Patient with uterine pathology untreated
• \- Couples with severe male factor, fresh count \<5 million / ml, and azoospermia in which the patient's sperm, epididymal or testicular is used

Sponsors & Collaborators

• Instituto de Investigacion Sanitaria La Fe: lead

Study Sites (1)

Human Reproduction Unit of the La Fe University and Politechnic Hospital

Valencia, 46026, Spain

Location

Related Publications (17)

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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MeSH Terms

Conditions

Infertility

Interventions

ganirelix; Chorionic Gonadotropin

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pregnancy Proteins; Proteins

Study Officials

• Roser Taroncher

  Hospital Universitario La Fe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2014
• First Posted: April 21, 2014
• Study Start: September 1, 2013
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: June 12, 2017

Record last verified: 2016-09

Locations

ES (1)