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
Recruitment status was Recruiting
Sponsor:
Regionshospitalet Viborg, Skive
Information provided by:
Regionshospitalet Viborg, Skive
ClinicalTrials.gov Identifier:
NCT01339299
First received: April 19, 2011
Last updated: May 2, 2011
Last verified: April 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Controlled Ovarian Stimulation Infertility |
Drug: recombinant luteinizing hormone (r-LH) Drug: recombinant human chorionic gonadotropin (r-hCG) |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Regionshospitalet Viborg, Skive:
Primary Outcome Measures:
- The oestradiol concentration on the day of ovulation induction [ Time Frame: treatment day 10 to 14 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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)
|
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)
|
|
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 )
|
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)
|
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01339299
Contacts
| Contact: Alice T Mikkelsen, RN | +45 78 44 57 66 | alice.tott.mikkelsen@Viborg.RM.dk |
Locations
| Denmark | |
| Fertility Clinic Skive regional Hospital | Recruiting |
| Skive, Denmark | |
| Contact: Alice T Mikkelsen +45 78 44 57 66 | |
Sponsors and Collaborators
Regionshospitalet Viborg, Skive
More Information
No publications provided
| Responsible Party: | Dr.Peter Humaidan, Skive regional hospital |
| ClinicalTrials.gov Identifier: | NCT01339299 History of Changes |
| Other Study ID Numbers: | 700642-603, 2009-009375-35 |
| Study First Received: | April 19, 2011 |
| Last Updated: | May 2, 2011 |
| Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics |
Keywords provided by Regionshospitalet Viborg, Skive:
|
COS ART Infertility |
Additional relevant MeSH terms:
|
Infertility Genital Diseases, Male Genital Diseases, Female Chorionic Gonadotropin Hormones Follicle Stimulating Hormone |
Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on May 16, 2013