RecruitingNot ApplicableNCT06635538

One-shot Ovarian Stimulation Protocol (One-shot)

One-Shot Ovarian Stimulation Protocol: A Pilot Study Investigating the Endocrine Profile


Sponsor

Fundación Santiago Dexeus Font

Enrollment

20 participants

Start Date

Oct 31, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years

Inclusion Criteria4

  • 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

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Interventions

DRUGCorifollitropin 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.

DRUGClomiphene 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_TESTMonitoring cycle

Scan controls and blood exams will be performed on stimulation days 1, 6, 8, 10 and, according to clinical needs, until trigger day.


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

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NCT06635538


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