PERgoveriS In Stratified Treatment for Assisted Reproductive Technique
NCT ID: NCT01297465
Last Updated: 2021-05-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
202 participants
INTERVENTIONAL
2011-05-31
2012-10-31
Brief Summary
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* GONAL-f®: (Liquid Pen; 300 international unit \[IU\] of per day) stimulation Day 1-5 followed by Pergoveris® (vial/powder, 300 IU per day) from stimulation Day 6 and until required recombinant human chorionic hormone (r-hCG) criterion is met. The dose can be adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
* Pergoveris®: (vial/powder, 300 IU per day) from stimulation Day 1 and until required r-hCG criterion is met. The dose can be adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
Randomization across the two treatment arms will be kept balanced in a 1:1 ratio. Follicular development will be monitored according to the center's standard practice by ultrasound (US) and/or estradiol (E2) levels, until the protocol r-hCG requirement is met (i.e., at least one follicle greater than or equal to \[\>=\] 18 millimeter \[mm\] and two follicles \>=16 mm). After this, a single injection of r-hCG will be administered in order to induce final oocyte maturation.
At a time of 34-38 hours after r-hCG administration, oocytes will be recovered vaginally under US monitoring. Oocytes will then be fertilized in vitro and embryos replaced 2-5 days after oocyte recovery. Ovum pick up (OPU), in vitro fertilization (IVF), embryo transfer (ET) and luteal support will be performed as per center's standard practice.
A post-treatment safety visit will be performed for all subjects who received r-hCG (pregnant and non- pregnant) on Day 15-20 post-hCG. For subjects who have withdrawn from treatment (i.e. after starting Pergoveris® or Gonal-f® but before hCG is given) this visit will take place 20-30 days after their first Pergoveris® or Gonal-f® treatment injection (excluding pregnancy testing).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Gonal-f® Plus Pergoveris®
Gonal-f®
Gonal-f® (follitropin alfa) 300 International Unit (IU) will be administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5).
Pergoveris®
Pergoveris® (follitropin alfa and lutropin alfa) 300 IU will be administered subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 1 follicles \>= 18 mm). The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
Recombinant human chorionic gonadotropin (r-hCG)
250 microgram of r-hCG will be administered once subcutaneously on r-hCG day (at least 1 follicles \>= 18 mm).
Pergoveris®
Pergoveris®
Pergoveris® (follitropin alfa and lutropin alfa) 300 IU will be administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles \>= 18 mm). The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
Recombinant human chorionic gonadotropin (r-hCG)
250 microgram of r-hCG will be administered once subcutaneously on r-hCG day (at least 1 follicles \>= 18 mm).
Interventions
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Gonal-f®
Gonal-f® (follitropin alfa) 300 International Unit (IU) will be administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5).
Pergoveris®
Pergoveris® (follitropin alfa and lutropin alfa) 300 IU will be administered subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 1 follicles \>= 18 mm). The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
Pergoveris®
Pergoveris® (follitropin alfa and lutropin alfa) 300 IU will be administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles \>= 18 mm). The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
Recombinant human chorionic gonadotropin (r-hCG)
250 microgram of r-hCG will be administered once subcutaneously on r-hCG day (at least 1 follicles \>= 18 mm).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Be between her 36th and 40th birthday (both included) at the time of the randomization visit
* Have early follicular phase (Day 2-4) serum level of basal follicle stimulating hormone (FSH less than or equal to (=\<)12 IU/L) measured in the center's local laboratory during the screening period (that is within 2 months prior to down-regulation start)
* A body mass index (BMI) less than (\<) 30 kilogram per square meter (kg/m\^2)
* Have a regular spontaneous ovulatory menstrual cycle between 21 and 35 days in length
* Be willing and able to comply with the protocol for the duration of the trial
* Have given written informed consent, prior to any trial-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to her future medical care
* Have a male partner with semen analysis within the past 6 months prior to randomization considered adequate to proceed with regular insemination or intracytoplasmic sperm injection (ICSI) according to the center's standard practice. If these criteria are not met, the subject can only be entered if donor sperm will be used
Exclusion Criteria
* Any medical condition, which in the judgment of the investigator may interfere with the absorption, distribution, metabolism or excretion of the drug. In case of doubt, the subject in question should be discussed with Merck Serono's medical responsible
* Had previous severe ovarian Hyperstimulation Syndrome (OHSS)
* Polycystic ovary syndrome (PCOS; Rotterdam criteria) to reduce the risk of the occurrence of OHSS
* Any contraindication to being pregnant and/or carrying a pregnancy to term
* History of 3 or more miscarriages (early or late miscarriages) due to any cause
* A clinically significant systemic disease
* Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus in the trial subject or her male partner
* Known allergy or hypersensitivity to human gonadotrophin preparations
* Entered previously into this trial or simultaneous participation in another clinical trial.
* Pregnancy and lactation period
* Participation in another clinical trial within the past 30 days
36 Years
40 Years
FEMALE
No
Sponsors
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Merck Serono S.A., Geneva
INDUSTRY
Merck A/S, Denmark
INDUSTRY
Merck OY, Finland
INDUSTRY
Merck Serono S.A.S, France
INDUSTRY
Merck Serono GmbH, Germany
INDUSTRY
Merck A.E., Greece
INDUSTRY
Merck B.V., Netherlands
INDUSTRY
Merck SP. Z.O.O., Poland
INDUSTRY
Merck Serono S.P.A., Italy
INDUSTRY
Merck Services U.K. Ltd, UK
INDUSTRY
LLC Merck, Russia
INDUSTRY
Merck spol. s r.o., Slovakia
INDUSTRY
Merck Pharma, K.S., Slovakia
INDUSTRY
Merck KGaA, Darmstadt, Germany
INDUSTRY
Responsible Party
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Principal Investigators
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Salvatore Longobardi, MD
Role: STUDY_DIRECTOR
Merck Serono S.P.A., Italy
Locations
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Research Site
Dronninglund, , Denmark
Research Site
Fredericia, , Denmark
Research Site
Helsinki, , Finland
Research Site
Bondy, , France
Research Site
Bruges, , France
Research Site
Clamart, , France
Research Site
Thenon, , France
Research Site
Villeurbanne, , France
Research Site
Berlin, , Germany
Research Site
Halle, , Germany
Research Site
Heraklion, Crete, Greece
Research Site
Pylaia, Thessaloniki, Greece
Research Site
Athens, , Greece
Research Site
Bologna, , Italy
Research Site
Florence, , Italy
Research Site
Torino, , Italy
Research Site
Zwolle, , Netherlands
Research Site
Warsaw, , Poland
Research Site
Moscow, , Russia
Research Site
Samara, , Russia
Research Site
Bratislava, , Slovakia
Research Site
London, , United Kingdom
Research Site
Swansea, , United Kingdom
Countries
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References
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H Behre, C Howles, S Longobardi. Luteinizing hormone supplementation from Day 1 versus 6 of ovarian stimulation in women aged 36-40 years: results from an open-label, randomized, multicentre, multinational trial. Human Reproduction. 2013;28(suppl 1)
Behre HM, Howles CM, Longobardi S; PERSIST Study Investigators. Randomized trial comparing luteinizing hormone supplementation timing strategies in older women undergoing ovarian stimulation. Reprod Biomed Online. 2015 Sep;31(3):339-46. doi: 10.1016/j.rbmo.2015.06.002. Epub 2015 Jun 15.
Other Identifiers
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2010-023534-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EMR 200061-504
Identifier Type: -
Identifier Source: org_study_id
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