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The purpose of this study is to evaluate the effect of administration of low dose of human chorionic gonadotropin (HCG) after use of clomiphene citrate (CC) for induction of ovulation in infertile women having CC resistant polycystic ovarian syndrome (PCOS).
Women will be randomly divided into two groups; CC-HCG group and CC group. Women in the CC-HCG group will receive CC (150 mg/day for 5 consecutive days from day 2 of cycle) and HCG (200 IU/day SC from day 7 of cycle). Women in the CC group will receive CC alone (150 mg/day for 5 consecutive days from day 2 of cycle). Transvaginal sonography (TVS) scan will be performed regularly for monitoring of follicular growth (folliculometry); starting from day 10 of the stimulation cycle and repeated every 2-3 days. When there will be at least one follicle ≥ 18 mm in diameter, final oocyte maturation will be induced by intramuscular administration of 10000 IU of HCG and timed intercourse will be advised. If there will be no follicle ≥ 12 mm by day 16 of the cycle, monitoring of follicular growth will be discontinued and the cycle will be presumed to be anovulatory. Ovulation will be documented by TVS scan one week after triggering of oocyte maturation and will be confirmed by assessing the midluteal serum progesterone level. Each woman will be subjected to ovarian stimulation for a maximum of 3 consecutive cycles except if she gets pregnant in the first or second cycle
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clomiphene citrate-HCG group | Active Comparator | Women will receive clomiphene citrate and human chorionic gonadotropin (HCG) |
|
| Clomiphene citrate group | Active Comparator | Women will receive clomiphene citrate alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clomiphene citrate and Human chorionic gonadotropin (HCG) | Drug | Women will receive clomiphene citrate (150 mg/day for 5 consecutive days from day 2 of cycle) and HCG (200 IU/day SC from day 7 of cycle) |
| Measure | Description | Time Frame |
|---|---|---|
| Ovulation rate | Number of ovulatory cycles divided by the number of stimulation cycles | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of ovarian follicles ≥ 18 mm on day of triggering of oocyte maturation | Number of ovarian follicles ≥ 18 mm by TVS on day of triggering of oocyte maturation | 3 months |
| Endometrial thickness on day of triggering of oocyte maturation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mahmoud Thabet, MD | Mansoura University | Principal Investigator |
| Khaled S Ismael, MD | Mansoura University | Study Director |
| Ahmed Ragab, MD | Mansoura University | Study Director |
| Maged R Elshamy, MD | Mansoura University | Study Director |
| Mohamed A Elnegery, MD | Mansoura University | Study Director |
| Hamed Youssef, MD | Mansoura University | Study Director |
| Mahmoud M Abdel-razik, MD | Mansoura University | Study Director |
| Mohamed S Abdelhafez, MD | Mansoura University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Obstetrics and Gynecology Department in Mansoura University Hospital | Al Mansurah | 35111 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39202581 | Derived | Thabet M, Abdelhafez MS, Elshamy MR, Albahlol IA, Fayala E, Wageeh A, El-Zayadi AA, Bahgat NA, Mohammed SM, Mohamed AA, Awad MM, El-Menayyer A, El-Sherbiny M, Elsherbini DMA, Albarakati RG, Alshaikh ABA, Edris FE, Bushaqer NJ, Salama YGM, Abdel-Razik MM. Competence of Combined Low Dose of Human Chorionic Gonadotropin (HCG) and Clomiphene Citrate (CC) Versus Continued CC during Ovulation Induction in Women with CC-Resistant Polycystic Ovarian Syndrome: A Randomized Controlled Trial. Medicina (Kaunas). 2024 Aug 12;60(8):1300. doi: 10.3390/medicina60081300. |
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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 |
|---|---|
| D002996 | Clomiphene |
| D006063 | Chorionic Gonadotropin |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
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|
| Clomiphene citrate | Drug | Women will receive clomiphene citrate (150 mg/day for 5 consecutive days from day 2 of cycle) |
|
|
Endometrial thickness by Transvaginal sonography (TVS) scan on day of triggering of oocyte maturation
| 3 months |
| Clinical pregnancy rate | Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 6-8 weeks gestational age) divided by the number of women | 6-8 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 |
| 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 |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D006062 | Gonadotropins |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010926 | Placental Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011257 | Pregnancy Proteins |
| D011506 | Proteins |