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NCT00756028·Phase 4·INTERVENTIONAL

Short Versus Long Protocol for IVF and IVF+ICSI

GanirelixOtherCompleted

Status

Completed

Phase

Phase 4

Enrollment

1,099

Locations

2

Results

Not posted

Publications

3

Study summary

What the protocol is testing.

Purpose: Comparing a GnRH agonist and an antagonist protocol for IVF/ICSI with regard to 1. frequency of ovarian hyperstimulation syndrome (OHSS) (1. outcome measure) 2. quality of life (2. outcome measure) 3. live birth rate (2. outcome measure) 4. gene expression profiles of granulosa and cumulus cells, and concentrations of estradiol and vascular endothelial growth factor in follicular fluid(not only compared between GnRH agonist and antagonist protocol, but also between patients with OHSS and no OHSS and patients becoming pregnant and not becoming pregnant (2. outcome measure), and 5. number of oocytes removed per treatment, number of embryo transfers per treatment and number of spontaneous abortions per treatment (these three parameters are tertiary outcome measures). In addition to the above mentioned efficacy outcome measures the safety outcome measure "frequency of known side-effects" will be compared between the two protocols.

Full detailed description

Patients: 1100 patients are randomized prospectively to either treatment. Stratification: =\<36 y/\>36 y, IVF/ICSI, and treatment centre. Methods: OHSS is quantified by consecutive measurements of weight, abdominal diameter, ultrasound measurements of ascites and ovarian volume, paraclinical parameters, and by a systematic patient questionnaire. Furthermore it is registered if the patients have been hospitalized and/or have had ascites drainage performed due to OHSS. Data from the first 100 patients are used together with Golans OHSS-classification, to make a more precise definition of OHSS. This definition is applied prospectively on data from the remaining patients. Quality of life is gauged by a questionnaire. Child birth rate is ascertained by a pregnancy response questionnaire and by obtaining data from the Danish National Birth Registry. Statistics: The study is designed to be able to show a 50% reduction of OHSS comparing short to long protocol.

Interventions

Treatment arms and agents.

DRUG

Patients receiving short protocol IVF/ICSI-treatment.

Injection s.c. Orgalutran® (Ganirelix)0.25 mg once daily from day 5 of FSH-stimulation until HCG-day

DRUG

Long protocol

Patients receiving long protocol IVF/ICSI-treatment. Intervention pharmacon: GnRH-agonist (Synarela®:Nafarelin)

Timeline

From registration to results.

  1. First posted

    Sep 19, 2008

  2. Study start

    Jan 2009

  3. Primary completion

    Dec 2014

  4. Study completion

    Dec 2015

  5. Results posted

    Not reported

  6. Registry updated

    Jan 13, 2016

Outcomes

What the study measures.

Primary outcomes

Frequency of Ovarian Hyperstimulation Syndrome (OHSS)

Time frame · 3 years

Secondary outcomes

Quality of life during treatment

Time frame · 3 years

Live births

Time frame · 3 years

Gene expression profiles of granulosa and cumulus cells

Time frame · 3 years

Estradiol and vascular endothelial growth factor concentrations in follicular fluid.

Time frame · 3 years

Eligibility

Who can take part.

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

Inclusion Criteria: * All patients referred for infertility receiving their first IVF or IVF+ICSI treatment Exclusion Criteria: * Previous IVF or IVF+ICSI-treatment * Uterine anomalies * It is necessary to perform direct sperm aspiration from husband's/partner's testicles * Allergy to one of the intervention products * Patient is 40 years or above

Study locations

2 registered sites.

Denmark. Showing up to 24 locations stored in the fast local snapshot.

Dronninglund Fertility Clinic

Dronninglund, Denmark

Fertility Clinic, Hvidovre Hospital

Hvidovre, Denmark

Publications

Results and literature.

PMID 29175067 ↗Toftager M, Sylvest R, Schmidt L, Bogstad J, Lossl K, Praetorius L, Zedeler A, Bryndorf T, Pinborg A. Quality of life and psychosocial and physical well-being among 1,023 women during their first assisted reproductive technology treatment: secondary outcome to a randomized controlled trial comparing gonadotropin-releasing hormone (GnRH) antagonist and GnRH agonist protocols. Fertil Steril. 2018 Jan;109(1):154-164. doi: 10.1016/j.fertnstert.2017.09.020. Epub 2017 Nov 23.PMID 28130435 ↗Toftager M, Bogstad J, Lossl K, Praetorius L, Zedeler A, Bryndorf T, Nilas L, Pinborg A. Cumulative live birth rates after one ART cycle including all subsequent frozen-thaw cycles in 1050 women: secondary outcome of an RCT comparing GnRH-antagonist and GnRH-agonist protocols. Hum Reprod. 2017 Mar 1;32(3):556-567. doi: 10.1093/humrep/dew358.PMID 27060174 ↗Toftager M, Bogstad J, Bryndorf T, Lossl K, Roskaer J, Holland T, Praetorius L, Zedeler A, Nilas L, Pinborg A. Risk of severe ovarian hyperstimulation syndrome in GnRH antagonist versus GnRH agonist protocol: RCT including 1050 first IVF/ICSI cycles. Hum Reprod. 2016 Jun;31(6):1253-64. doi: 10.1093/humrep/dew051. Epub 2016 Apr 8.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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