EUCTR2013-003817-16-HU
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®in ART
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]
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
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The current trial will enroll poor ovarian responders as aligned with the 2011 Consensus Meeting of the ESHRE
- •1\. Subject must be a poor responder
- •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
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
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