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The purpose of this study is to compare the clinical outcomes of recombinant human chorionic gonadotrophin (rHCG) and urinary HCG (uHCG) in patients undergoing IVF cycles.
Urinary human chorionic gonadotrophin (u-hCG) has been widely used to induce final oocyte maturation and to trigger ovulation in assisted conception. Recombinant technology has allowed the production of r-hCG inj which all urinary contaminants are absent. Hence, this would allow the safe subcutaneous administration of a compound with less batch-to-batch variation. This study will investigate the effectiveness of the recombinant hCG compared to the currently used urinary hCG.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rHCG 250 ug | Active Comparator | Injection of 250 ug Ovitrelle to trigger final oocyte maturation |
|
| uHCG 5000 IU | Active Comparator | Injection of 5000 IU Pregnyl to trigger final oocyte maturation |
|
| uHCG 7500 IU | Active Comparator | Injection of 7500 IU Pregnyl to trigger final oocyte maturation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rHCG 250ug | Drug | Injection of 250 ug Ovitrelle to trigger final oocyte maturation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of mature oocytes | Percentage MII/COCs | Day of oocyte retrieval (Day 0) |
| Measure | Description | Time Frame |
|---|---|---|
| Positive test per embryo transfer | 15 days post oocyte retrieval | |
| Clinical pregnancy per embryo transfer | 7 weeks of gestation | |
| Ongoing pregnancy per embryo transfer |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tryfon Lainas, PhD | Eugonia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eugonia | Athens | 11528 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16848893 | Background | Revelli A, Poso F, Gennarelli G, Moffa F, Grassi G, Massobrio M. Recombinant versus highly-purified, urinary follicle-stimulating hormone (r-FSH vs. HP-uFSH) in ovulation induction: a prospective, randomized study with cost-minimization analysis. Reprod Biol Endocrinol. 2006 Jul 18;4:38. doi: 10.1186/1477-7827-4-38. | |
| 15846677 |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D006063 | Chorionic Gonadotropin |
| ID | Term |
|---|---|
| D006062 | Gonadotropins |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| uHCG 5000 IU | Drug | Injection of 5000 IU Pregnyl to trigger final oocyte maturation |
|
|
| uHCG 7500 IU | Drug | Injection of 7500 IU Pregnyl to trigger final oocyte maturation |
|
|
| 12 weeks of gestation |
| Level of serum hCG on day of oocyte retrieval | Day of oocyte retrieval |
| Number of oocytes (COC) retrieved | Day of oocyte retrieval |
| Number of mature oocytes (MII) | Day of oocyte retrieval |
| Oocyte retrieval rate | Number of oocytes retrieved/number of follicles on the day of triggering final oocyte maturation | Day of oocyte retrieval (Day 0) |
| Incidence of severe early OHSS | up to Day 5 post oocyte retrieval |
| Al-Inany HG, Aboulghar M, Mansour R, Proctor M. Recombinant versus urinary human chorionic gonadotrophin for ovulation induction in assisted conception. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD003719. doi: 10.1002/14651858.CD003719.pub2. |
| D010926 | Placental Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011257 | Pregnancy Proteins |
| D011506 | Proteins |