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Completed

NCT Number: NCT03356964

Step Down FSH Approach and Late Follicular Phase in Progesterone Level

Step-down approach and late follicular phase progesterone level

Completed

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Key information

Conditions

Progesterone Resistance

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

IVI Middle East Fertilty Clinic

Abu Dhabi, United Arab Emirates

About this study

The study will be performed using the stimulation medication Gonal-F which is a recombinant FSH-preparation. Due to application as pen-device, it allows reduction of the stimulation dosage in steps of 12.5IU.

It is important to evaluate the dynamics of progesterone-rise after final oocyte maturation, as this dynamic might also have an influence on the receptivity of the endometrium.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Primary / secondary infertility with the indication for IVF/ICSI
  • Patients age 18 - 40 years
  • 60 kg up to and including 90 kg
  • BMI of 18-32 kg/m2
  • Menstrual cycle length of 24-35 days

Exclusion criteria

An individual who meets any of the following criteria will be excluded from participation in this study:

Exclusion criteria

  • presence or history of an endocrine abnormality
  • abnormal outcome of blood biochemistry or hematology
  • relevant ovarian-, tubal- or uterine-pathology that could interfere with the ovarian stimulation treatment
  • history of ovarian hyper-response (more than 30 follicles ≥ 11 mm) or ovarian hyper-stimulation syndrome (OHSS), polycystic ovary syndrome (PCOS)
  • History of poor ovarian response, according to the Rotterdam-criteria (Ferrarretti et al.)
  • ovarian reserve parameter, indicating the risk of poor ovarian response (AFC < 5 and AMH < 0,5ng/ml) (14)

Treatment and study plan

follicle stimulating hormone

Drug

Follicle stimulating hormone( will be chosen according to ovarian reserve parameters in the study group the dosage will be reduced in the control group it will remain unchanged

Other names: Gonal-F

Primary outcomes

  1. Impact of dose reduction in recFSH for IVF on the progesterone level.

    Time frame: 1year and 6 months

    Whether higher progesterone levels on the day of trigger will lead to rapid rise of progesterone after ovulation induction compared to lower progesterone levels.

Sponsors and collaborators

Lead sponsor

ART Fertility Clinics LLC

Other

Collaborators

  • Merck Serono International SA

Registry information

Official study title

Impact of Step-down Approach During Late Follicular Phase in Recombinant FSH-stimulation Dosage for IVF on Progesterone Level on the Day of Final Oocyte Maturation

Acronym: FSH

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Nov 29, 2017
Registry last updated
Sep 9, 2020

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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