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The accurate identification and efficient management of poor responders remains one of the most enigmatic challenges in assisted reproductive technology (ART). The investigators study will compare the letrozole/antagonist protocol to the hMG/antagonist protocol in women who poor responders.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| human menopausal gonadotropin (hMG) | Active Comparator | hMG at a dose of 300 IU/day will be initiated on the second or third day of spontaneous menstruation and continued until the day of ovulation triggering. Ovulation triggering will be performed with the administration of 10000 IU of human chorionic gonadotropin (hCG) as soon as two-three follicles of 17 mm diameter will be observed by transvaginal ultrasound. |
|
| Letrozole | Active Comparator | Letrozole (Femara; Novartis, East Hanover, NJ) at a dose of 5 mg/day will be initiated on the second or third day of spontaneous menstruation and continued for 5 days. Again on the second or third day of spontaneous menstruation, 150 IU of hMG will be started until the day of ovulation triggering. Ovulation triggering will be performed with the administration of 10000 IU of hCG as soon as two-three follicles of 17 mm diameter will be observed by transvaginal ultrasound. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Letrozole | Drug |
|
| |
| human menopausal gonadotropin (hMG) |
| Measure | Description | Time Frame |
|---|---|---|
| Ongoing pregnancy rate | The primary outcome measure will be the ongoing pregnancy rate (>12 weeks' gestation) per started cycle. | up to 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cancellation Rate | One of the secondary outcome measures will be cancellation rate. | up to one month |
| Number of oocytes retrieved | One of the secondary outcome measures will be number of oocytes retrieved. |
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Inclusion Criteria:
Patients will be considered eligible if they are poor ovarian responders according to the Bologna criteria (Ferraretti et al., 2011).
Two out of three of the following criteria are essential in order to classify a patient as poor ovarian responder:
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| Name | Affiliation | Role |
|---|---|---|
| Harika Yumru, M.D. | Istanbul University School of Medicine | Principal Investigator |
| Hasan F Buyru, M.D. Prof. | Istanbul University School of Medicine | Study Chair |
| Ercan Bastu, M.D. | Istanbul University School of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Obstetrics and Gynecology, Istanbul University School of Medicine | Istanbul | 34093 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21505041 | Background | Ferraretti AP, La Marca A, Fauser BC, Tarlatzis B, Nargund G, Gianaroli L; ESHRE working group on Poor Ovarian Response Definition. ESHRE consensus on the definition of 'poor response' to ovarian stimulation for in vitro fertilization: the Bologna criteria. Hum Reprod. 2011 Jul;26(7):1616-24. doi: 10.1093/humrep/der092. Epub 2011 Apr 19. |
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| ID | Term |
|---|---|
| D000077289 | Letrozole |
| D008596 | Menotropins |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 |
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| Drug |
|
| up to one month |
| Number of transferable embryos | One of the secondary outcome measures will be number of transferable embryos. | up to one month |
| Implantation rate | One of the secondary outcome measures will be implantation rates. | up to 2 weeks |
| Clinical pregnancy rate | One of the secondary outcome measures will be clinical pregnancy rates. | up to 2 weeks |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006065 | Gonadotropins, Pituitary |
| D006062 | Gonadotropins |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |