Step Down FSH Approach and Late Follicular Phase in Progesterone Level (FSH)

September 8, 2020 updated by: Prof Dr. Human Fatemi, ART Fertility Clinics LLC

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

Step-down approach and late follicular phase progesterone level

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

127

Phase

  • Early Phase 1

Contacts and Locations

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

Study Locations

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

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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)

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
Follicle stimulating Hormone will be applied, starting from day 3 of the cycle, the dosage will be choosen between Gonal F 150 - 225 IU, according to the ovarian reserve parameters (13). The stimulation dosage will remain unchanged until the criteria for final oocyte maturation are met (≥ 3 follicles of ≥ 17 mm).
Drug: follicle stimulating hormone
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
Experimental: Study group
Follicle stimulating Hormone will be applied, starting from day 3 of the cycle, the dosage will be choosen between Gonal F 150 - 225 IU, according to the ovarian reserve parameters (LaMarca et al.). As soon as ≥ 3 follicle of a size of 14mm are seen, the stimulation dosage will be reduced daily by 12.5 IU recFSH until the criteria for final oocyte maturation are met (≥ 3 follicles of ≥ 17 mm).
Drug: follicle stimulating hormone
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1year and 6 months

Collaborators and Investigators

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

Sponsor

ART Fertility Clinics LLC

Collaborators

Merck Serono International SA

Investigators

  • Principal Investigator: Human Fatemi, ART Fertility Clinics LLC

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

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)

November 23, 2017

Primary Completion (Actual)

February 12, 2020

Study Completion (Actual)

August 31, 2020

Study Registration Dates

First Submitted

November 14, 2017

First Submitted That Met QC Criteria

November 23, 2017

First Posted (Actual)

November 29, 2017

Study Record Updates

Last Update Posted (Actual)

September 9, 2020

Last Update Submitted That Met QC Criteria

September 8, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1612-ABU-084-HF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on Progesterone Resistance

Clinical Trials on follicle stimulating hormone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Senegal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe