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

Skip to Main Content

ClinicalTrials.gov

Home Search Study Topics Glossary


	Full Text View


	Tabular View


	Study Results


	Related Studies

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

This study has been completed.

Study NCT00778999 Information provided by Schering-Plough

First Received on October 23, 2008. Last Updated on December 12, 2011 History of Changes

Results First Received: June 23, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Infertility
Intervention:	Drug: Marvelon

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
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

	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

Hide Baseline Characteristics

Reporting Groups

	Description
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

	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 [ Time Frame: 12 weeks ]

Show Outcome Measure 1

2. Secondary:

Number of Mature Oocytes [ Time Frame: 12 weeks ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

3. Secondary:

Number of Follicles on Stimulation Day 8 [ Time Frame: 12 weeks ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

4. Secondary:

Number of Follicles on Day of hCG [ Time Frame: 12 weeks ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

5. Secondary:

Number of Fertilized (2PN) Oocytes [ Time Frame: 12 weeks ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

6. Secondary:

Number of Good Quality Embryos [ Time Frame: 12 weeks ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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: Sponsor 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 the Sponsor for written consent, which shall not be withheld unreasonably. Sponsor 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
No text entered.

Results Point of Contact:

Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@merck.com

No publications provided by Schering-Plough

Publications automatically indexed to this study:

Andersen AN, Witjes H, Gordon K, Mannaerts B; Xpect investigators. Predictive factors of ovarian response and clinical outcome after IVF/ICSI following a rFSH/GnRH antagonist protocol with or without oral contraceptive pre-treatment. Hum Reprod. 2011 Dec;26(12):3413-23. Epub 2011 Sep 27.

Responsible Party:	Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00778999 History of Changes
Obsolete Identifiers:	NCT00628641
Other Study ID Numbers:	142003, P05696
Study First Received:	October 23, 2008
Results First Received:	June 23, 2009
Last Updated:	December 12, 2011
Health Authority:	United States: Food and Drug Administration

Back to top of Main Content