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The purpose of this study is to compare the efficacy of in vitro fertilization (IVF) versus gonadotropin therapy in infertile women having clomiphene citrate (CC) resistant polycystic ovarian syndrome (PCOS).
Women will be randomly divided into two groups; IVF group and gonadotropin group. Women in the IVF group will undergo one full IVF cycle. Women in the gonadotropin group will be subjected to ovarian stimulation for 6 months with the gonadotropin low-dose step-down protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVF group | Active Comparator | Women will undergo one full IVF cycle |
|
| Gonadotropin group | Active Comparator | Women will be subjected to ovarian stimulation for 6 months with the gonadotropin low-dose step-down protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVF | Procedure | Women will undergo one IVF cycle |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Live birth rate | Number of live births divided by the number of women | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical pregnancy rate | Number of clinical pregnancies divided by the number of women | 6-8 weeks gestational age |
| Multifetal pregnancy rate | Number of multifetal pregnancies divided by the number of clinical pregnancies |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed Gibreel, Dr | Mansoura University | Principal Investigator |
| Mohamed S Abdelhafez, Dr | Mansoura University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fertility Care Unit (FCU) in Mansoura University Hospital | Al Mansurah | Dakahlia Governorate | 35111 | Egypt | ||
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| ID | Term |
|---|---|
| D007246 | Infertility |
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
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| ID | Term |
|---|---|
| D020554 | Sperm Injections, Intracytoplasmic |
| D006062 | Gonadotropins |
| D008596 | Menotropins |
| ID | Term |
|---|---|
| D005307 | Fertilization in Vitro |
| D027724 | Reproductive Techniques, Assisted |
| D012099 | Reproductive Techniques |
| D013812 | Therapeutics |
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| Gonadotropin | Drug | Women will be subjected to ovarian stimulation for 6 months with the gonadotropin low-dose step-down protocol |
|
|
| 12 weeks gestational age |
| Miscarriage rate | Number of first trimester miscarriages (before 12 weeks gestational age) divided by the number of clinical pregnancies | 12 weeks gestational age |
| Incidence of early ovarian hyperstimulation syndrome (OHSS) | Incidence of OHSS within 9 days of final triggering of oocyte maturation | Within 9 days of final triggering of oocyte maturation |
| Private fertility care centers |
| Al Mansurah |
| Dakahlia Governorate |
| Egypt |
| D009369 |
| Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D008919 | Investigative Techniques |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D006065 | Gonadotropins, Pituitary |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |