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One-shot Ovarian Stimulation Protocol (One-shot)

F

Fundación Santiago Dexeus Font

Status

Enrolling

Conditions

Infertility, Female

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06635538
FSD-ONE-2024-09

Details and patient eligibility

About

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

Enrollment

20 estimated patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

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

Trial contacts and locations

3

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Central trial contact

Nikolaos P Polyzos, MD, PhD; Ignacio Rodríguez, MSc

Data sourced from clinicaltrials.gov

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