PERgoveriS In Stratified Treatment for Assisted Reproductive Technique (PERSIST)

This study has been completed.

Sponsor:

Collaborators:

Merck Serono S.A., Geneva

Merck A/S, Denmark

Merck OY, Finland

Merck Serono S.A.S, France

Merck Serono GmbH, Germany

Merck A.E., Greece

Merck B.V., Netherlands

Merck SP. Z.O.O., Poland

Merck Serono S.P.A., Italy

Merck Services U.K. Ltd, UK

LLC Merck, Russia

Merck spol. s r.o., Slovakia

Merck Pharma, K.S., Slovakia

Information provided by (Responsible Party):

Merck KGaA

ClinicalTrials.gov Identifier:

NCT01297465

First received: February 15, 2011

Last updated: January 10, 2014

Last verified: January 2014

History of Changes

Results First Received: October 23, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Conditions:	Assisted Reproductive Techniques Reproductive Technology, Assisted
Interventions:	Drug: Gonal-f® Drug: Pergoveris® Drug: Recombinant human chorionic gonadotropin (r-hCG)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

Description

Gonal-f® Plus Pergoveris®

Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. 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 was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.

Participant Flow: Overall Study

	Gonal-f® Plus Pergoveris®	Pergoveris®
STARTED	99	103
COMPLETED	91	93
NOT COMPLETED	8	10
Lack of Ovarian Response	1	1
Ovarian hyperstimulation syndrome risk	0	1
No Oocytes Retrieved	1	1
Poor oocyte quality	0	1
No Fertilization	6	4
All Embryos Discarded	0	1
Intention to Freeze all Embryos	0	1

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population included all the randomized participants who had received at least 1 dose of Pergoveris® or Gonal-f®.

Reporting Groups

	Description
Gonal-f® Plus Pergoveris®	Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. 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 was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
Total	Total of all reporting groups

Baseline Measures

	Gonal-f® Plus Pergoveris®	Pergoveris®	Total
Overall Participants Analyzed [Units: Participants]	99	103	202

Age [Units: Years] Mean (Standard Deviation)	37.6 (1.16)	37.4 (1.14)	37.5 (1.15)

Gender [Units: Participants]
Female	99	103	202
Male	0	0	0

Race [Units: Participants]
Black	4	3	7
Asian	4	6	10
Other	2	2	4
White	89	92	181

Height [Units: Centimeter] Mean (Standard Deviation)	166.1 (6.49)	166.3 (6.47)	166.2 (6.46)

Weight [Units: Kilogram] Mean (Standard Deviation)	64.81 (10.364)	65.82 (8.923)	65.33 (9.645)

Outcome Measures

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1. Primary:

Total Number of Oocytes Retrieved [ Time Frame: OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 11 days}]) ]

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2. Secondary:

Total Dose and Mean Daily Dose of Follicle Stimulating Hormone (FSH) [ Time Frame: Day 1 up to r-hCG day (end of stimulation cycle [approximately 11 days]) ]

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3. Secondary:

Total Number of Stimulation Treatment Days [ Time Frame: Day 1 up to r-hCG day (end of stimulation cycle [approximately 11 days]) ]

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4. Secondary:

Implantation Rate [ Time Frame: Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days]) ]

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5. Secondary:

Number of Fetal Sacs With Activity [ Time Frame: Days 35-42 post r-hCG day [end of stimulation cycle {approximately 11 days}]) ]

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6. Secondary:

Number of Fetal Hearts With Activity [ Time Frame: Days 35-42 post r-hCG day [end of stimulation cycle {approximately 11 days}]) ]

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7. Secondary:

Clinical Pregnancy Rate [ Time Frame: Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days]) ]

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8. Secondary:

Number of Participants With Cancelled Cycles Due to Excessive or Insufficient Ovarian Response to Treatment [ Time Frame: S1 until Day 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days]) ]

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9. Secondary:

Biochemical Pregnancies Rate [ Time Frame: Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days]) ]

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10. Secondary:

Number of Participants With Multiple Pregnancies [ Time Frame: Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days]) ]

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11. Secondary:

Number of Participants With Early and Late Ovarian Hyper Stimulation Syndrome (OHSS) [ Time Frame: Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days]) ]

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12. Secondary:

Number of Participants With Treatment-emergent Adverse Events [ Time Frame: Day 1 up to days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days]) ]

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13. Secondary:

Systolic and Diastolic Arterial Blood Pressure Assessments [ Time Frame: Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days]) ]

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14. Secondary:

Heart Rate Assessments [ Time Frame: Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days]) ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Results Point of Contact:

Name/Title: Merck KGaA Communication Center
Organization: Merck Serono, a division of Merck KGaA
phone: +49-6151-72-5200
e-mail: service@merckgroup.com

Publications of Results:

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)

Responsible Party:	Merck KGaA
ClinicalTrials.gov Identifier:	NCT01297465 History of Changes
Other Study ID Numbers:	EMR 200061-504 2010-023534-23 ( EudraCT Number )
Study First Received:	February 15, 2011
Results First Received:	October 23, 2013
Last Updated:	January 10, 2014

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