One-shot Ovarian Stimulation Protocol (One-shot)

Not Applicable

Recruiting

• Conditions: Infertility, Female
• Interventions: 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

• Registration Number: NCT06635538
• Lead Sponsor: Fundación Santiago Dexeus Font

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-07
• Study First Submitted QC: 2024-10-09
• Study First Posted: 2024-10-10
• Study Start: 2024-10-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-26
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 20

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
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	-
Corifollitropin alfa (CFA) 150 mcg + Clomiphene Citrate (CC) 100 mg/day from D1	Clomiphene Citrate (CC) 100 mg/day from D1	-
Corifollitropin alfa (CFA) 150 mcg + Clomiphene Citrate (CC) 100 mg/day from D1	Monitoring cycle	-

Primary Outcome Measures

Name	Time	Method
Estradiol	days 1, 6, 8, 10,the day of ovulation triggering, the day of ovulation triggering day+1 and 7 days after oocyte retrieval	Estradiol levels
Progesterone	days 1, 6, 8, 10,the day of ovulation triggering, the day of ovulation triggering day+1 and 7 days after oocyte retrieval	Progesterone levels
Follicle stimulating hormone (FSH)	days 1, 6, 8, 10,the day of ovulation triggering, the day of ovulation triggering day+1 and 7 days after oocyte retrieval	FSH levels
Luteinizing hormone (LH)	days 1, 6, 8, 10,the day of ovulation triggering, the day of ovulation triggering day+1 and 7 days after oocyte retrieval	LH levels

Secondary Outcome Measures

Name	Time	Method
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	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
Follicle-to-oocyte index (FOI)	7 -20 days from initiation of ovarian stimulation	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
Cancellation rate	7 -20 days from initiation of ovarian stimulation
Ovarian hyperstimulation syndrome (OHSS) rate	Until 15 days after punction

Trial Locations

Locations (3)

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