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)

NCTNCT01339299Other id700642-603Other id2009-009375-35Other id2009

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 4
Enrollment: 100 participants (actual)
Sponsor: Regionshospitalet Viborg, Skive · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
Denmark
Start: Oct 2009
Primary completion: Jul 2012
Completion: Jul 2012
First posted: 20 Apr 2011 (estimated)
Last update posted: 27 Nov 2013 (estimated)
Conditions: Controlled Ovarian Stimulation · Infertility

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20092010201120122013

Ph 4
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)
NCT01339299
Oct 2009 to Jul 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

recombinant luteinizing hormone (r-LH)Drug
recombinant human chorionic gonadotropin (r-hCG)Drug

Arms2

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)
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 )

Primary outcomes1

Outcomes the sponsor listed as primary.

The Oestradiol Concentration on the Day of Ovulation Induction
Time frame · treatment day 10 to 14

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· treatment day 10 to 14

The Oestradiol Concentration on the Day of Ovulation Induction

Group	Value (pmol/L)	Spread
Recombinant Human Chorionic Gonadotrofin	11482	8210
Recombinant Luteinizing Hormone	12262	8100

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Recombinant Human Chorionic Gonadotrofin25 IU of r-hCG from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14 ) 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)	–	0 / 50	0 / 50
Recombinant Luteinizing Hormone150 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) 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)	–	0 / 50	0 / 50

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 35 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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