Other Complications Associated With Artificial Fertilization
Conditions
Keywords
In Vitro Fertilization, Testosterone, Ovarian Stimulation, Luteinizing Hormone
Brief summary
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.
Detailed description
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.
Interventions
DRUGTestosterone and FSHr-LHr
75U of LHr added to FSHr ovarian stimulation in IVF, when testosterone was used to improve the ovarian response
DRUGtestosterone and FSHr alone
FSHr alone used in ovarian stimulation in IVF, when testosterone was used to improve the ovarian response
Sponsors
Hospital Clinic of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 41 Years
Healthy volunteers
Yes
Inclusion criteria
* Low responder patients: patients with previously canceled cycle or recovery of 3 or less oocytes
Exclusion criteria
* FSH \> 12 * Previous ovarian surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ovarian response | within 2 weeks after begining ovarian stimulation | number of oocytes obtained per ovarian stimulation cycle |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| clinical pregnancy rate | within 5 weeks (plus or minus 1 week) after embryo transfer | 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. |
| Implantation rate | within 5 weeks (plus/minus 1 week) after embryo transfer | The number of gestational sacs (observed by ultrasound examination) divided by the number of embryos transferred. |
| Live birth rate | within 9 months (plus/minus 1 month) after embryo transfer | The number of deliveries that resulted in at least one live born baby expressed per 100 embryo transfer cycles. |
Countries
Spain
Outcome results
None listed