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Impact of FSH Dosage During Ovarian Stimulation for IVF/ICSI in Granulosa Cells

NCT05330130 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-01-09

No results posted yet for this study

Summary

To study the influence of different daily rec-FSH dosages (150 IU versus 300 IU), performed in the same patient in consecutive cycles, on the relation between FSH- and LH-receptors of the granulosa cells of the growing follicle.

Conditions

  • Ovarian Function Insufficiency
  • Fertility Issues
  • Infertility,Female
  • Infertility

Interventions

DRUG

Follitropin beta injection 150 IU

Participants commence ovarian stimulation on day 2 or 3 of their menstrual cycle with a daily dosage of 150 IU rec-FSH. The dosage will remain constant throughout the course of the stimulation. From the morning of the 5th stimulation day, GnRH-antagonist will be administered daily to prevent LH-rise. As soon as ≥ 3 follicle of a size of 17mm are seen, 0.3 mg GnRH-Agonist will be administered for final oocyte maturation. During ovarian stimulation, follicle puncture procedures with the aspiration of follicular fluid will be performed at the following time: * one follicle on the morning of day 5, before the administration of the first GnRH-antagonist * one follicle of the size of 12 to 14 mm, when at least 2 to 3 follicles have reached a size of 12 to 14 mm * two follicles (= pre-ovulatory follicle) on the morning of the day of final oocyte maturation. Oocyte retrieval of all other follicles will be carried out 36 hours after injection of the medication for final oocyte maturation.

DRUG

Follitropin beta injection 300 IU

Participants commence ovarian stimulation on day 2 or 3 of their menstrual cycle with a daily dosage of 300 IU rec-FSH. The dosage will remain constant throughout the course of the stimulation. From the morning of the 5th stimulation day, GnRH-antagonist will be administered daily to prevent LH-rise. As soon as ≥ 3 follicle of a size of 17mm are seen, 0.3 mg GnRH-Agonist will be administered for final oocyte maturation. During ovarian stimulation, follicle puncture procedures with the aspiration of follicular fluid will be performed at the following time: * one follicle on the morning of day 5, before the administration of the first GnRH-antagonist * one follicle of the size of 12 to 14 mm, when at least 2 to 3 follicles have reached a size of 12 to 14 mm * two follicles (= pre-ovulatory follicle) on the morning of the day of final oocyte maturation. Oocyte retrieval of all other follicles will be carried out 36 hours after injection of the medication for final oocyte maturation.

Sponsors & Collaborators

  • Organon and Co

    collaborator INDUSTRY

  • ART Fertility Clinics LLC

    lead OTHER

Principal Investigators

  • Barbara Lawrenz, PhD · ART Fertility Clinics LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
38 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-05
Primary Completion
2024-03-30
Completion
2024-06-30

Countries

  • United Arab Emirates

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05330130 on ClinicalTrials.gov