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Clinical Trials/EUCTR2013-003817-16-NL
EUCTR2013-003817-16-NL
Active, not recruiting
Not Applicable

A phase III, randomized, controlled, single-blind,multicentre, parallel arm trial to assess theefficacy and safety of Pergoveris® (follitropin alfaand lutropin alfa) and GONAL-f® (follitropinalfa) for multifollicular development as part of anassisted reproductive technology treatment cyclein poor ovarian responders, as defined by theEuropean Society of Human Reproduction andEmbryology criteria - ESPART Evaluating the Efficacy and the Safety of Pergoveris (r) in ART

Merck KGaA0 sites946 target enrollmentJanuary 3, 2014
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ConditionsPoor Ovarian Response i.e. a failure to respond adequately to standard ART (assisted reproductive technologies) protocols and to recruit adequate folliclesMedDRA version: 17.0Level: LLTClassification code 10033140Term: Ovarian disorder NOSSystem Organ Class: 100000004872Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]
DrugsPergoveris 150 IU-75 IU Powder and solvent for solution for injectionGONAL-f 450 IU/0.75 ml (33 micrograms/0.75 ml) powder and solvent for solution for injection

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Poor Ovarian Response i.e. a failure to respond adequately to standard ART (assisted reproductive technologies) protocols and to recruit adequate follicles
Sponsor
Merck KGaA
Enrollment
946
Status
Active, not recruiting
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 3, 2014
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
Merck KGaA

Eligibility Criteria

Inclusion Criteria

  • •The current trial will enroll poor ovarian responders according as aligned with the 2011 Consensus Meeting of the ESHRE. 1\. Subject must be a poor responde
  • •at least 2 of the following 3 features must be present:
  • •\- ESHRE criteria \= Advanced maternal age (\= 40 years) or any risk factor for POR\- INCLUSION for this study: yes (\<41 years), no for any risk factor.
  • •\- ESHRE criteria \= A previous POR (\= 3 oocytes with a conventional stimulation protocol). INCLUSION for this study: Yes.
  • •\- ESHRE criteria \= An abnormal ovarian reserve test (ORT) (ie, anti\-mullerian hormone \[AMH] \< 0\.5 \- 1\.1 ng mL). INCLUSION for this study: Yes for AMH only (\=\> lower limit of assay detection \-1\.3 ng/mL, inclusive)
  • •Additional inclusion criteria are:
  • •2\. Female subjects, 18 to \< 41 years of age (according to date of birth at time of informed consent) who are eligible for ovarian stimulation and ART treatment, including ICSI
  • •3\. Absence of anatomical abnormalities of the reproductive tract that would interfere with implantation or pregnancy
  • •4\. Absence of any medical condition in which pregnancy is contraindicated
  • •5\. Body mass index 18 to 30 kg/m2, inclusive

Exclusion Criteria

  • •1\. Primary ovarian failure
  • •2\. Preimplantation genetic screening or diagnosis
  • •3\. Two episodes of POR after maximal stimulation
  • •4\. History or presence of tumors of the hypothalamus or pituitary gland
  • •5\. History or presence of ovarian enlargement or cyst of unknown etiology, or presence of an ovarian cyst \> 25 mm on the day of randomization
  • •6\. Presence of endometriosis grade III – IV, confirmed or suspected
  • •7\. Presence of uni\- or bilateral hydrosalpinx
  • •8\. Abnormal gynecological bleeding of undetermined origin
  • •9\. Malformations of sexual organs incompatible with pregnancy
  • •10\. Contraindication to being pregnant and/or carrying a pregnancy to term

Outcomes

Primary Outcomes

Not specified

Similar Trials

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A study to compare Pergoveris and GONAL-f in women who have responded poorly to previous infertiliy treatment cyclesPoor Ovarian Response i.e. a failure to respond adequately to standard ART (assisted reproductive technologies) protocols and to recruit adequate folliclesMedDRA version: 17.0Level: LLTClassification code 10033140Term: Ovarian disorder NOSSystem Organ Class: 100000004872Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]
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