Clinical trial NCT06635538: One-shot Ovarian Stimulation Protocol (One-shot)
Official title: One-Shot Ovarian Stimulation Protocol: A Pilot Study Investigating the Endocrine Profile
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infertility, Female
Lead sponsor: Fundacion Dexeus
Sponsor class: OTHER
First posted: 2024-10-10
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The current prospective observational pilot study aims to evaluate the endocrine profile of a single-injection protocol (single CFA + daily oral administration of CC).


Eligibility criteria: 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

Primary outcomes:
measure: Estradiol
timeFrame: days 1, 6, 8, 10,the day of ovulation triggering, the day of ovulation triggering day+1 and 7 days after oocyte retrieval
measure: Progesterone
timeFrame: days 1, 6, 8, 10,the day of ovulation triggering, the day of ovulation triggering day+1 and 7 days after oocyte retrieval
measure: Follicle stimulating hormone (FSH)
timeFrame: days 1, 6, 8, 10,the day of ovulation triggering, the day of ovulation triggering day+1 and 7 days after oocyte retrieval
measure: Luteinizing hormone (LH)
timeFrame: days 1, 6, 8, 10,the day of ovulation triggering, the day of ovulation triggering day+1 and 7 days after oocyte retrieval
Secondary outcomes:
measure: Days of stimulation
timeFrame: 7 -20 days from initiation of ovarian stimulation
measure: Number of oocytes retrieved (COCs)
timeFrame: 7 -20 days from initiation of ovarian stimulation
measure: Number of MII oocytes
timeFrame: 7 -20 days from initiation of ovarian stimulation
measure: Follicular Output Rate (FORT)
timeFrame: 7 -20 days from initiation of ovarian stimulation
measure: Follicle-to-oocyte index (FOI)
timeFrame: 7 -20 days from initiation of ovarian stimulation
measure: Cancellation rate
timeFrame: 7 -20 days from initiation of ovarian stimulation
measure: Ovarian hyperstimulation syndrome (OHSS) rate
timeFrame: Until 15 days after punction
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Dexeus Mujer Sabadell
state: Barcelona
city: Sant Cugat Del Vallès
country: Spain
facility: Dexeus Mujer Sant Cugat
state: Barcelona
city: Barcelona
country: Spain
facility: Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus
Study officials:
affiliation: Dexeus Fertility
name: Nikolaos P Polyzos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.