Predictive Factors for Ovarian Stimulation Using a Fixed Daily Dose of 200 IU Recombinant FSH (Study 142003)(COMPLETED)(P05696) - Study Results

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment
Condition:	Infertility
Intervention:	Drug: Desogen/Marvelon

Participant Flow

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
Desogen Oral Contraceptive	Use of oral contraceptive pills prior to controlled ovarian stimulation
Non-Oral Contraceptive	No use of oral contraceptive pills prior to controlled ovarian stimulation

Participant Flow: Overall Study

	Desogen Oral Contraceptive	Non-Oral Contraceptive
STARTED	223	219
COMPLETED	195	185
NOT COMPLETED	28	34
Discontinuation: no embryo transfer	14	14
Did not receive recFSH	14	20

Baseline Characteristics

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Reporting Groups

	Description
Desogen Oral Contraceptive	Use of oral contraceptive pills prior to controlled ovarian stimulation
Non-Oral Contraceptive	No use of oral contraceptive pills prior to controlled ovarian stimulation

Baseline Measures

	Desogen Oral Contraceptive	Non-Oral Contraceptive	Total
Number of Participants [units: participants]	223	219	442
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	223	219	442
>=65 years	0	0	0
Gender [units: participants]
Female	223	219	442
Male	0	0	0

Outcome Measures

1. Primary:

Total Number of Oocytes [ 12 weeks ]

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Serious Adverse Events

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Other Adverse Events

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Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
Desogen Oral Contraceptive	Use of oral contraceptive pills prior to controlled ovarian stimulation
Non-Oral Contraceptive	No use of oral contraceptive pills prior to controlled ovarian stimulation

Other Adverse Events

	Desogen Oral Contraceptive	Non-Oral Contraceptive
Total, other (not including serious) adverse events
# participants affected / at risk	88	81
Gastrointestinal disorders
Nausea ^† # participants affected / at risk # events	8/209 (3.83%) 8	15/199 (7.54%) 18
Injury, poisoning and procedural complications
Procedural pain ^† # participants affected / at risk # events	53/209 (25.36%) 55	45/199 (22.61%) 45
Nervous system disorders
Headache ^† # participants affected / at risk # events	17/209 (8.13%) 23	12/199 (6.03%) 12
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous ^† # participants affected / at risk # events	8/209 (3.83%) 8	12/199 (6.03%) 12
Antepartum haemorrhage ^† # participants affected / at risk # events	11/209 (5.26%) 14	9/199 (4.52%) 13
Reproductive system and breast disorders
Ovarian hyperstimulation syndrome ^† # participants affected / at risk # events	5/209 (2.39%) 5	11/199 (5.53%) 11
Pelvic discomfort ^† # participants affected / at risk # events	20/209 (9.57%) 21	14/199 (7.04%) 16
Pelvic pain ^† # participants affected / at risk # events	18/209 (8.61%) 20	14/199 (7.04%) 14

^†	Indicates events were collected by systematic assessment.

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. Restriction Description: Organon recognizes the right of the investigator(s) to publish, but all communication concerning the clinical trial must be based on data validated and released and will first be submitted to Organon for written consent, which shall not be withheld unreasonably. Organon is free to use the data for publication. The investigator(s) may be invited to be co‑author(s). In any communication concerning this clinical trial, the author(s) of this protocol will be included in the list of authors.

Limitations and Caveats

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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Results Point of Contact:

Name/Title: Head, Clinical Trials Registry & Results Disclosure Group
Organization: NV Organon, part of S-P corporation
e-mail: ClinicalTrialsDisclosure@spcorp.com

No publications provided

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	142003, P05696
Study First Received:	October 23, 2008
Results First Received:	June 23, 2009
Last Updated:	October 2, 2009
ClinicalTrials.gov Identifier:	NCT00778999 History of Changes
Health Authority:	United States: Food and Drug Administration