One-shot Ovarian Stimulation Protocol (One-shot) (One-shot)

February 25, 2025 updated by: Fundación Santiago Dexeus Font

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ignacio Rodríguez, MSc
  • Phone Number: 22029 0034932274700
  • Email: nacrod@dexeus.com

Study Contact Backup

  • Name: Nikolaos P Polyzos, MD, PhD
  • Phone Number: 0034932274700
  • Email: nikpol@dexeus.com

Study Locations

  • Spain
      • Barcelona, Spain, 08037
        • Not yet recruiting
        • Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus
        • Contact:
        • Principal Investigator:
          • Nikolaos P Polyzos, MD PhD
        • Sub-Investigator:
          • Valeria Donno, MD
    • Barcelona
      • Sabadell, Barcelona, Spain, 08203
        • Recruiting
        • Dexeus Mujer Sabadell
        • Contact:
          • Silvia Grau, MD
        • Principal Investigator:
          • Silvia Grau
      • Sant Cugat Del Vallès, Barcelona, Spain, 08195
        • Recruiting
        • Dexeus Mujer Sant Cugat
        • Contact:
          • Silvia Grau, MD
        • Principal Investigator:
          • Silvia Grau, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Corifollitropin alfa (CFA) 150 mcg + Clomiphene Citrate (CC) 100 mg/day from D1
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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 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)
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
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)
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days of stimulation
Time Frame: 7 -20 days from initiation of ovarian stimulation
7 -20 days from initiation of ovarian stimulation
Number of oocytes retrieved (COCs)
Time Frame: 7 -20 days from initiation of ovarian stimulation
7 -20 days from initiation of ovarian stimulation
Number of MII oocytes
Time Frame: 7 -20 days from initiation of ovarian stimulation
7 -20 days from initiation of ovarian stimulation
Follicular Output Rate (FORT)
Time Frame: 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
7 -20 days from initiation of ovarian stimulation
Follicle-to-oocyte index (FOI)
Time Frame: 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
7 -20 days from initiation of ovarian stimulation
Cancellation rate
Time Frame: 7 -20 days from initiation of ovarian stimulation
7 -20 days from initiation of ovarian stimulation
Ovarian hyperstimulation syndrome (OHSS) rate
Time Frame: Until 15 days after punction
Until 15 days after punction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Santiago Dexeus Font

Investigators

  • Principal Investigator: Nikolaos P Polyzos, MD, PhD, Dexeus Fertility

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

October 7, 2024

First Submitted That Met QC Criteria

October 9, 2024

First Posted (Actual)

October 10, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 25, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FSD-ONE-2024-09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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