Current partner codePEPTIDESDE
NCT01816321·Phase 3·INTERVENTIONAL

Corifollitropin Alfa Followed by Menotropin for Poor Ovarian Responders Trial

Status

Completed

Phase

Phase 3

Enrollment

150

Locations

2

Results

Not posted

Publications

6

Study summary

What the protocol is testing.

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.

Full detailed description

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

Interventions

Treatment arms and agents.

DRUG

Corifollitropin alfa

Corifollitropin alfa 150μg on day 2 of the menstrual cycle (stimulation day 1)

DRUG

recombinant FSH

recombinant FSH 300IU/daily from day 2 of the cycle (stimulation day 8)until day of ovulation triggering

DRUG

Ganirelix

Ganirelix 0.25mg/daily from day 7 of the cycle(stimulation day 6) until day of ovulation triggering

DRUG

hp HMG

hp HMG 300IU/daily from day 9 of the cycle (stimulation day 8)until day of ovulation triggering

Timeline

From registration to results.

  1. First posted

    Mar 22, 2013

  2. Study start

    Mar 2013

  3. Primary completion

    May 2016

  4. Study completion

    May 2016

  5. Results posted

    Not reported

  6. Registry updated

    Jun 23, 2016

Outcomes

What the study measures.

Primary outcomes

Ongoing pregnancy

Time frame · 9-10 weeks of gestation

The presence of intrauterine gestational sac with an embryonic pole demonstrating cardiac activity at 9-10 weeks of gestation.

Secondary outcomes

Clinical pregnancy

Time frame · 7 weeks of gestation

The presence of intrauterine gestational sac at 7 weeks of gestation

Biochemical pregnancy

Time frame · 2 weeks after embryo transfer

Positive pregnancy test 2 weeks after embryo transfer

Number of oocytes retrieved

Time frame · 9 -20 days from initiation of ovarian stimulation

The outcome will be evaluated on the day of oocyte retrieval

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
39 Years
Sex
FEMALE
Healthy volunteers
No

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

Study locations

2 registered sites.

Belgium · Vietnam. Showing up to 24 locations stored in the fast local snapshot.

Universitair Ziekenhuis Brussel

Brussels, Belgium

University of Medicine and Pharmacy of Ho Chi Minh City

Ho Chi Minh City, Vietnam

Publications

Results and literature.

PMID 23442756Polyzos 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.PMID 23084565Polyzos 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.PMID 22940767Polyzos 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.PMID 22036048Polyzos 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.PMID 21505041Ferraretti 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.PMID 29040589Drakopoulos 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.

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