Study to Examine Effect of Recombinant Luteinizing Hormone (r-Lh) and Recombinant Human Chorionic Gonadotropin (r-hCG) for Ovarian Stimulation in Assisted Reproduction Techniques (ART)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2011 by Regionshospitalet Viborg, Skive.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Regionshospitalet Viborg, Skive

ClinicalTrials.gov Identifier:

NCT01339299

First received: April 19, 2011

Last updated: May 2, 2011

Last verified: April 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

April 19, 2011

Last Updated Date

May 2, 2011

Start Date ^ICMJE

October 2009

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The oestradiol concentration on the day of ovulation induction [ Time Frame: treatment day 10 to 14 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01339299 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study to Examine Effect of Recombinant Luteinizing Hormone (r-Lh) and Recombinant Human Chorionic Gonadotropin (r-hCG) for Ovarian Stimulation in Assisted Reproduction Techniques (ART)

Official Title ^ICMJE

The Endocrine Efficacy of Either Recombinant Luteinizing Hormone (r-LH) or Low Dose Recombinant Human Chorionic Gonadotropin (r-hCG) Supplementation for Recombinant Follicle Stimulating Hormone (r-FSH) Stimulation in Normogonadotrophic Women Undergoing in Vitro Fertilization (IVF)/Intracytoplasmic Sperm Injection (ICSI) Therapy Following a Long-term Gonadotropin Releasing Hormone (GnRH) Agonist Down Regulation Protocol

Brief Summary

The study is a prospective, randomised, controlled, and non-blinded multi-center pilot study to evaluate endocrine efficacy of recombinant luteinizing hormone versus recombinant human chorionic gonadotropin administered during controlled ovarian stimulation for IVF/ICSI in normogonadotrophic women.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science

Condition ^ICMJE

Controlled Ovarian Stimulation
Infertility

Intervention ^ICMJE

Drug: recombinant luteinizing hormone (r-LH)
administration of r-LH 150 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)
Drug: recombinant human chorionic gonadotropin (r-hCG)
administration of r-hCG 25 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)

Study Arm (s)

Experimental: recombinant luteinizing hormone
150 IU r-LH, recombinant luteinising hormone, from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14)

Intervention: Drug: recombinant luteinizing hormone (r-LH)
Active Comparator: recombinant human chorionic gonadotrofin
25 IU of r-hCG from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14 )

Intervention: Drug: recombinant human chorionic gonadotropin (r-hCG)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

100

Estimated Completion Date

December 2011

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Women who plan to undergo IVF or ICSI treatment
Woman's age > 18 years but ≤ 35 years
Regular menstrual cycle (25-34 days)
BMI 18 to 30 inclusive
Signed patient information and informed consent forms

Exclusion Criteria:

PCOS
More than 2 prior IVF/ICSI attempts
Diabetes mellitus, epilepsy, lever-, kidney-, heart- and metabolism disorders, according to the Investigator's assessment.

Gender

Female

Ages

18 Years to 35 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Alice T Mikkelsen, RN

+45 78 44 57 66

alice.tott.mikkelsen@Viborg.RM.dk

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT01339299

Other Study ID Numbers ^ICMJE

700642-603, 2009-009375-35

Has Data Monitoring Committee

Responsible Party

Dr.Peter Humaidan, Skive regional hospital

Study Sponsor ^ICMJE

Regionshospitalet Viborg, Skive

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Regionshospitalet Viborg, Skive

Verification Date

April 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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