Recruiting NCT06635538
One-shot Ovarian Stimulation Protocol (One-shot)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Corifollitropin alfa (CFA) 150 mcg + Clomiphene Citrate (CC) 100 mg/day from D1, Clomiphene Citrate (CC) 100 mg/day from D1, Monitoring cycle.
- Who it may be relevant to
- Registry conditions: Infertility, Female. Basic parameters: 18 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
One-Shot Ovarian Stimulation Protocol: A Pilot Study Investigating the Endocrine Profile
Overview
The current prospective observational pilot study aims to evaluate the endocrine profile of a single-injection protocol (single CFA + daily oral administration of CC).
Interventions
- Drug 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. - Drug 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 - Diagnostic test 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.
Primary outcome measures
- Estradiol [Time frame: days 1, 6, 8, 10,the day of ovulation triggering, the day of ovulation triggering day+1 and 7 days after oocyte retrieval]
- Progesterone [Time frame: 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) [Time frame: 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) [Time frame: days 1, 6, 8, 10,the day of ovulation triggering, the day of ovulation triggering day+1 and 7 days after oocyte retrieval]
Secondary outcome measures (7)
- Days of stimulation [Time frame: 7 -20 days from initiation of ovarian stimulation]
- Number of oocytes retrieved (COCs) [Time frame: 7 -20 days from initiation of ovarian stimulation]
- Number of MII oocytes [Time frame: 7 -20 days from initiation of ovarian stimulation]
- Follicular Output Rate (FORT) [Time frame: 7 -20 days from initiation of ovarian stimulation]
- Follicle-to-oocyte index (FOI) [Time frame: 7 -20 days from initiation of ovarian stimulation]
- Cancellation rate [Time frame: 7 -20 days from initiation of ovarian stimulation]
- Ovarian hyperstimulation syndrome (OHSS) rate [Time frame: Until 15 days after punction]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Spain · 3 centers
- Dexeus Mujer Sabadell — Sabadell
- Dexeus Mujer Sant Cugat — Sant Cugat del Vallès
- Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus — Barcelona
Publications
- 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. PMID 33742206
- 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. PMID 31081407
- 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. PMID 1374895
- 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. PMID 2497133
- 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. PMID 23809505
- 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. PMID 3924949
- 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. PMID 9111183
- 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. PMID 17697488
Identifiers
NCT: NCT06635538 · FSD-ONE-2024-09