A Phase 4 interventional study of recombinant luteinizing hormone (r-LH) and recombinant human chorionic gonadotropin (r-hCG) in Controlled Ovarian Stimulation and Infertility, sponsored by Regionshospitalet Viborg, Skive. Completed at 1 site in Denmark. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2013-11-27.
Sponsored by Regionshospitalet Viborg, Skive · Phase 4, Interventional, and Basic science
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.
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's enrollment of 100 is below the median of 120 across 1,698 interventional studies indexed under Infertility.
Browse Infertility studies →Regionshospitalet Viborg, Skive is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
Drug: recombinant luteinizing hormone (r-LH)
25 IU of r-hCG from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14 )
Drug: recombinant human chorionic gonadotropin (r-hCG)
administration of r-LH 150 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)
administration of r-hCG 25 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)
The Oestradiol Concentration on the Day of Ovulation Induction
Time frame: treatment day 10 to 14
| Milestone | Recombinant Human Chorionic Gonadotrofin | Recombinant Luteinizing Hormone |
|---|---|---|
| Started | 50 | 50 |
| Completed | 50 | 50 |
| Not completed | 0 | 0 |
| pmol/L | Recombinant Human Chorionic Gonadotrofin | Recombinant Luteinizing Hormone |
|---|---|---|
| The Oestradiol Concentration on the Day of Ovulation Induction | 11482 ± 8210 | 12262 ± 8100 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Recombinant Human Chorionic Gonadotrofin | — | 0/50 (0%) | 0/50 (0%) |
| Recombinant Luteinizing Hormone | — | 0/50 (0%) | 0/50 (0%) |
| Age, Categorical(Participants) | Recombinant Human Chorionic Gonadotrofin | Recombinant Luteinizing Hormone | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 50 | 50 | 100 |
| >=65 years | 0 | 0 | 0 |
| Age Continuous(years) | Recombinant Human Chorionic Gonadotrofin | Recombinant Luteinizing Hormone | Total |
|---|---|---|---|
| Mean | 29.7 ± 3.1 | 30.1 ± 3.2 | 29.9 ± 3.1 |
| Sex: Female, Male(Participants) | Recombinant Human Chorionic Gonadotrofin | Recombinant Luteinizing Hormone | Total |
|---|---|---|---|
| Female | 50 | 50 | 100 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Recombinant Human Chorionic Gonadotrofin | Recombinant Luteinizing Hormone | Total |
|---|---|---|---|
| Denmark | 50 | 50 | 100 |
This study is completed, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.
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Regionshospitalet Viborg, Skive