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NCT Number: NCT06635538

One-shot Ovarian Stimulation Protocol (One-shot)

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

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Key information

Conditions

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

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dexeus Mujer Sabadell, Sabadell, Barcelona, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. Days of stimulation

    Time frame: 7 -20 days from initiation of ovarian stimulation

  2. Number of oocytes retrieved (COCs)

    Time frame: 7 -20 days from initiation of ovarian stimulation

  3. Number of MII oocytes

    Time frame: 7 -20 days from initiation of ovarian stimulation

  4. 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

  5. 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

  6. Cancellation rate

    Time frame: 7 -20 days from initiation of ovarian stimulation

  7. Ovarian hyperstimulation syndrome (OHSS) rate

    Time frame: Until 15 days after punction

Study contacts

Contact information is provided by the study sponsor or research team.

Ignacio Rodríguez, MSc

CONTACT

[email protected]

0034932274700 ext. 22029

Nikolaos P Polyzos, MD, PhD

CONTACT

[email protected]

0034932274700

Sponsors and collaborators

Lead sponsor

Fundación Santiago Dexeus Font

Other

Registry information

Official study title

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

Acronym: One-shot

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 10, 2024
Registry last updated
Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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