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The current prospective observational pilot study aims to evaluate the endocrine profile of a single-injection protocol (single CFA + daily oral administration of CC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corifollitropin alfa (CFA) 150 mcg + Clomiphene Citrate (CC) 100 mg/day from D1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corifollitropin alfa (CFA) 150 mcg + Clomiphene Citrate (CC) 100 mg/day from D1 | Drug | On day 2 or 3 of the menstrual cycle or after 5 days of pill-free interval, a single injection of 150 mcg of CFA (Stimulation Day 1) will be administered. |
| Measure | Description | Time Frame |
|---|---|---|
| Estradiol | Estradiol levels | days 1, 6, 8, 10,the day of ovulation triggering, the day of ovulation triggering day+1 and 7 days after oocyte retrieval |
| Progesterone | Progesterone levels | days 1, 6, 8, 10,the day of ovulation triggering, the day of ovulation triggering day+1 and 7 days after oocyte retrieval |
| Follicle stimulating hormone (FSH) | FSH levels | days 1, 6, 8, 10,the day of ovulation triggering, the day of ovulation triggering day+1 and 7 days after oocyte retrieval |
| Luteinizing hormone (LH) | LH levels | days 1, 6, 8, 10,the day of ovulation triggering, the day of ovulation triggering day+1 and 7 days after oocyte retrieval |
| Measure | Description | Time Frame |
|---|---|---|
| Days of stimulation | 7 -20 days from initiation of ovarian stimulation | |
| Number of oocytes retrieved (COCs) | 7 -20 days from initiation of ovarian stimulation | |
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Inclusion Criteria:
Age <= 40
AMH (Anti-Mullerian Hormone) 1.2-3.5 ng/ml or AFC 7-20
No family history of hereditary or chromosomal diseases
Body mass index (BMI) 18 to 30 kg/m2
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nikolaos P Polyzos, MD, PhD | Contact | 0034932274700 | nikpol@dexeus.com | |
| Ignacio Rodríguez, MSc | Contact | 0034932274700 | 22029 | nacrod@dexeus.com |
| Name | Affiliation | Role |
|---|---|---|
| Nikolaos P Polyzos, MD, PhD | Dexeus Fertility | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dexeus Mujer Sabadell | Recruiting | Sabadell | Barcelona | 08203 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33742206 | Background | Martinez F, Racca A, Rodriguez I, Polyzos NP. Ovarian stimulation for oocyte donation: a systematic review and meta-analysis. Hum Reprod Update. 2021 Jun 22;27(4):673-696. doi: 10.1093/humupd/dmab008. | |
| 31081407 | Background | Martinez F, Rodriguez-Purata J, Clua E, Garcia S, Coroleu B, Polyzos N. Ovarian response in oocyte donation cycles under LH suppression with GnRH antagonist or desogestrel progestin: retrospective and comparative study. Gynecol Endocrinol. 2019 Oct;35(10):884-889. doi: 10.1080/09513590.2019.1604662. Epub 2019 May 12. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C437186 | follicle stimulating hormone, human, with HCG C-terminal peptide |
| D002996 | Clomiphene |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
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| Clomiphene Citrate (CC) 100 mg/day from D1 | Drug | On day 2 or 3 of the menstrual cycle or after 5 days of pill-free interval, the patients will start oral administration of Clomiphene Citrate 100/day continuing up to and including the day of ovulation triggering |
|
| Monitoring cycle | Diagnostic Test | Scan controls and blood exams will be performed on stimulation days 1, 6, 8, 10 and, according to clinical needs, until trigger day. |
|
| Number of MII oocytes |
| 7 -20 days from initiation of ovarian stimulation |
| Follicular Output Rate (FORT) | expressed as the ratio between the total number of oocytes retrieved at oocyte pick-up and the number of antral follicles available at the start of stimulation | 7 -20 days from initiation of ovarian stimulation |
| Follicle-to-oocyte index (FOI) | expressed as the ratio between the total number of oocytes retrieved at oocyte pick-up and the number of antral follicles available at the start of stimulation | 7 -20 days from initiation of ovarian stimulation |
| Cancellation rate | 7 -20 days from initiation of ovarian stimulation |
| Ovarian hyperstimulation syndrome (OHSS) rate | Until 15 days after punction |
| Dexeus Mujer Sant Cugat | Recruiting | Sant Cugat del Vallès | Barcelona | 08195 | Spain |
|
| Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus | Not yet recruiting | Barcelona | 08037 | Spain |
|
| 1374895 | Background | Fares FA, Suganuma N, Nishimori K, LaPolt PS, Hsueh AJ, Boime I. Design of a long-acting follitropin agonist by fusing the C-terminal sequence of the chorionic gonadotropin beta subunit to the follitropin beta subunit. Proc Natl Acad Sci U S A. 1992 May 15;89(10):4304-8. doi: 10.1073/pnas.89.10.4304. |
| 2497133 | Background | Glasier AF, Irvine DS, Wickings EJ, Hillier SG, Baird DT. A comparison of the effects on follicular development between clomiphene citrate, its two separate isomers and spontaneous cycles. Hum Reprod. 1989 Apr;4(3):252-6. doi: 10.1093/oxfordjournals.humrep.a136882. |
| 23809505 | Background | Practice Committee of the American Society for Reproductive Medicine. Use of clomiphene citrate in infertile women: a committee opinion. Fertil Steril. 2013 Aug;100(2):341-8. doi: 10.1016/j.fertnstert.2013.05.033. Epub 2013 Jun 27. |
| 3924949 | Background | Kerin JF, Liu JH, Phillipou G, Yen SS. Evidence for a hypothalamic site of action of clomiphene citrate in women. J Clin Endocrinol Metab. 1985 Aug;61(2):265-8. doi: 10.1210/jcem-61-2-265. |
| 9111183 | Background | Dickey RP, Holtkamp DE. Development, pharmacology and clinical experience with clomiphene citrate. Hum Reprod Update. 1996 Nov-Dec;2(6):483-506. doi: 10.1093/humupd/2.6.483. |
| 17697488 | Background | Teramoto S, Kato O. Minimal ovarian stimulation with clomiphene citrate: a large-scale retrospective study. Reprod Biomed Online. 2007 Aug;15(2):134-48. doi: 10.1016/s1472-6483(10)60701-8. |
| 3150950 | Background | Messinis IE, Templeton A. Blockage of the positive feedback effect of oestradiol during prolonged administration of clomiphene citrate to normal women. Clin Endocrinol (Oxf). 1988 Nov;29(5):509-16. doi: 10.1111/j.1365-2265.1988.tb03700.x. |
| 34672261 | Background | Melo AS, Paula CTV, Santos TLD, Faria VAC, Rufato MAF, Barboza RP, Barreto J. Corifollitropin alpha, clomiphene citrate and dydrogesterone without daily gonadotrophin: a new option of a friendly protocol for high-responder oocyte donors. JBRA Assist Reprod. 2022 Apr 17;26(2):315-320. doi: 10.5935/1518-0557.20210082. |
| D000091662 | Genital Diseases |
| D007246 | Infertility |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |