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The investigators have previously demonstrated the utility of transdermal testosterone in in vitro fertilization (IVF) low responder patients. Now, the investigators want to evaluate the efficacy of luteinizing hormone (LH) activity added to recombinant follicular stimulating hormone (FSHr) during ovarian stimulation in these patients.
Studies in macaques have indicated that androgens have some synergistic effects with follicular stimulating hormone (FSH) on folliculogenesis. Our previous clinical studies demonstrated the usefulness of pretreatment with transdermal testosterone in low-responder IVF patients.
There is controversy on the usefulness of recombinant luteinizing hormone (LHr) added to FSHr in ovarian stimulation of low responder patients. Thus, our present study has been designed to compare ovarian stimulation with FSHr alone versus LHr added to FSHr when transdermal testosterone pretreatment is used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Testosterone and FSHr | Active Comparator |
| |
| testosterone and FSHr-LHr | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone and FSHr-LHr | Drug | 75U of LHr added to FSHr ovarian stimulation in IVF, when testosterone was used to improve the ovarian response |
|
| Measure | Description | Time Frame |
|---|---|---|
| ovarian response | number of oocytes obtained per ovarian stimulation cycle | within 2 weeks after begining ovarian stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| clinical pregnancy rate | The number of clinical pregnancies expressed per embryo transfer cycles. Clinical pregnancy: a pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy. Multiple gestational sacs are counted as one clinical pregnancy. | within 5 weeks (plus or minus 1 week) after embryo transfer |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnic | Barcelona | Barcelona | 08036 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16517559 | Background | Balasch J, Fabregues F, Penarrubia J, Carmona F, Casamitjana R, Creus M, Manau D, Casals G, Vanrell JA. Pretreatment with transdermal testosterone may improve ovarian response to gonadotrophins in poor-responder IVF patients with normal basal concentrations of FSH. Hum Reprod. 2006 Jul;21(7):1884-93. doi: 10.1093/humrep/del052. Epub 2006 Mar 3. | |
| 19054777 |
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| ID | Term |
|---|---|
| D013739 | Testosterone |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| testosterone and FSHr alone | Drug | FSHr alone used in ovarian stimulation in IVF, when testosterone was used to improve the ovarian response |
|
| Implantation rate | The number of gestational sacs (observed by ultrasound examination) divided by the number of embryos transferred. | within 5 weeks (plus/minus 1 week) after embryo transfer |
| Live birth rate | The number of deliveries that resulted in at least one live born baby expressed per 100 embryo transfer cycles. | within 9 months (plus/minus 1 month) after embryo transfer |
| Fabregues F, Penarrubia J, Creus M, Manau D, Casals G, Carmona F, Balasch J. Transdermal testosterone may improve ovarian response to gonadotrophins in low-responder IVF patients: a randomized, clinical trial. Hum Reprod. 2009 Feb;24(2):349-59. doi: 10.1093/humrep/den428. Epub 2008 Dec 3. |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |