One-shot Ovarian Stimulation Protocol (One-shot)

NCT06635538 | Recruiting

• 1 other identifier: FSD-ONE-2024-09
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

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).

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (7)

• Days of stimulation

  7 -20 days from initiation of ovarian stimulation

• Number of oocytes retrieved (COCs)

  7 -20 days from initiation of ovarian stimulation

• Number of MII oocytes

  7 -20 days from initiation of ovarian stimulation

• Follicular Output Rate (FORT)

  7 -20 days from initiation of ovarian stimulation

• Follicle-to-oocyte index (FOI)

  7 -20 days from initiation of ovarian stimulation

Study Arms (1)

Corifollitropin alfa (CFA) 150 mcg + Clomiphene Citrate (CC) 100 mg/day from D1

EXPERIMENTAL

Drug: Corifollitropin alfa (CFA) 150 mcg + Clomiphene Citrate (CC) 100 mg/day from D1; Drug: Clomiphene Citrate (CC) 100 mg/day from D1; Diagnostic Test: Monitoring cycle

Interventions

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.

Corifollitropin alfa (CFA) 150 mcg + Clomiphene Citrate (CC) 100 mg/day from D1

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

Corifollitropin alfa (CFA) 150 mcg + Clomiphene Citrate (CC) 100 mg/day from D1

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.

Corifollitropin alfa (CFA) 150 mcg + Clomiphene Citrate (CC) 100 mg/day from D1

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Fundación Santiago Dexeus Font: lead

Study Sites (3)

Dexeus Mujer Sabadell

Sabadell, Barcelona, 08203, Spain

RECRUITING

Dexeus Mujer Sant Cugat

Sant Cugat del Vallès, Barcelona, 08195, Spain

RECRUITING

Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus

Barcelona, 08037, Spain

NOT YET RECRUITING

Related Publications (10)

• 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 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.

  PMID: 31081407 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.

  PMID: 1374895 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.

  PMID: 2497133 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.

  PMID: 23809505 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.

  PMID: 3924949 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.

  PMID: 9111183 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.

  PMID: 17697488 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.

  PMID: 3150950 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.

  PMID: 34672261 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Infertility, Female

Interventions

follicle stimulating hormone, human, with HCG C-terminal peptide; Clomiphene

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Nikolaos P Polyzos, MD, PhD

  Dexeus Fertility

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nikolaos P Polyzos, MD, PhD

CONTACT

0034932274700; nikpol@dexeus.com

Ignacio Rodríguez, MSc

CONTACT

0034932274700; nacrod@dexeus.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 10, 2024
• Study Start: October 31, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: February 26, 2025

Record last verified: 2025-02

Locations

ES (3)