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Recent findings suggest that letrozole may be a superior Clomiphene Citrate.
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Women with polycystic ovary syndrome (PCOS) can suffer from infertility because they do not produce an egg each month, resulting in irregular periods. As a result, these women often need a medication called clomiphene citrate (clomiphene) to induce ovulation. A traditional 'clomiphene protocol' begins with a short course of progestin treatment to bring on a period (termed a 'withdrawal bleed') before starting the clomiphene medication. Newer evidence, however, has suggested that this progestin-induced shedding of the uterine lining (i.e., withdrawal bleed) may decrease the chances of pregnancy. The purpose of our study is to determine whether withdrawal bleeding has an impact on pregnancy rates for patients with PCOS undergoing a clomiphene cycle.
It is hypothesized that patients who undergo ovulation induction with clomiphene citrate without prior endometrial shedding will have higher clinical pregnancy rates than those who begin with a progestin-induced withdrawal bleed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No withdrawal bleed | Experimental | No progestin prior to ovulation induction with clomiphene citrate |
|
| Withdrawal Bleed | No Intervention | Progestin prior to beginning ovulation induction with clomiphene citrate (standard care) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progestin | Drug | The experimental group will have no progestin prior to ovulation induction with clomiphene citrate, while the comparison group will have progestin medication prior to ovulation induction with clomiphene citrate, as per usual care. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical pregnancy rate per ovulation | clinical pregnancy rate (gestational sac seen on ultrasound approximately 6-7 weeks after starting clomiphene) per ovulation | 6 weeks after starting clomiphene |
| Measure | Description | Time Frame |
|---|---|---|
| cumulative pregnancy rate | cumulative pregnancy rate | assessed 9 months after the ovulation induction cycles |
| ovulation rate | ovulation rate (progesterone >10nmol/L per clomiphene cycle) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jon Havelock, MD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pacific Centre for Reproductive Medicine | Burnaby | British Columbia | V5G 4X7 | Canada |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D007246 | Infertility |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| D011372 | Progestins |
| D017258 | Medroxyprogesterone Acetate |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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|
| assessed 1 month after each induced ovulation cycle |
| ongoing pregnancy rate | ongoing pregnancy rate (pregnancy with a fetal heartbeat >12 weeks gestational age) | assessed 12 weeks after clinical pregnancy is acheived |
| miscarriage rate | miscarriage rate | Assessed 4 months after clinical pregnancy acheived |
| multiple pregnancy rate | multiple pregnancy rate (twins and higher order multiples) | Assessed 4 months after clinical pregnancy acheived |
| endometrial thickness | endometrial thickness (assessed via transvaginal ultrasound) | Assessed at 1 month after conception |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D020164 | Chemical Actions and Uses |
| D008525 | Medroxyprogesterone |
| D006908 | Hydroxyprogesterones |
| D011374 | Progesterone |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |