Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2024-10-31
2025-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Corifollitropin alfa (CFA) 150 mcg + Clomiphene Citrate (CC) 100 mg/day from D1
Corifollitropin alfa (CFA) 150 mcg + Clomiphene Citrate (CC) 100 mg/day from D1
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.
Clomiphene Citrate (CC) 100 mg/day from D1
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
Scan controls and blood exams will be performed on stimulation days 1, 6, 8, 10 and, according to clinical needs, until trigger day.
Interventions
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Corifollitropin alfa (CFA) 150 mcg + Clomiphene Citrate (CC) 100 mg/day from D1
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.
Clomiphene Citrate (CC) 100 mg/day from D1
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
Scan controls and blood exams will be performed on stimulation days 1, 6, 8, 10 and, according to clinical needs, until trigger day.
Eligibility Criteria
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Inclusion Criteria
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
18 Years
40 Years
FEMALE
No
Sponsors
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Fundación Santiago Dexeus Font
OTHER
Responsible Party
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Principal Investigators
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Nikolaos P Polyzos, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Dexeus Fertility
Locations
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Dexeus Mujer Sabadell
Sabadell, Barcelona, Spain
Dexeus Mujer Sant Cugat
Sant Cugat del Vallès, Barcelona, Spain
Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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Silvia Grau, MD
Role: primary
Silvia Grau, MD
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Related Info
Other Identifiers
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FSD-ONE-2024-09
Identifier Type: -
Identifier Source: org_study_id
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