Effect of Recombinant Follicular Stimulating Hormone (FSH) Dosing Following Cori-follitropin Alfa

NCT03686852 | Unknown

• 1 other identifier: rFSHdosingfinding.2018
• Study Type: interventional
• Target: 261
• Locations: 0 countries
• Sites: N/A

Brief Summary

In the trial, women planned to be treated with 150μg corifollitropin alfa followed by rFSH in a fixed GnRH antagonist protocol will be asked to participate and sign the ICF. Corifollitropin alpha treatment will be initiated at D2-D3 of the cycle. Patients who need additional r-FSH following corifollitropin-alfa will be randomized on day 8 of the stimulation into 3 study groups. In group A, B and C, ovarian stimulation with Corifollitropin alfa (Elonva®, MSD) will be used for ovarian stimulation, followed by 50IU (Group A), 150IU (Group B) or 250IU (Group C) of recFSH (Puregon®, MSD).

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• serum progesterone level on the day of the trigger

  Compare the mean serum progesterone level (ng/mL) on day of hCG between the study groups.

  2 years

Secondary Outcomes (4)

• Number of oocytes retrieved

  2 years

• Number of patients who underwent freeze all the embryos (FA)

  2 years

• Clinical pregnancy rate

  2 years

• Miscarriage rate

  2 years

Study Arms (3)

group A

ACTIVE COMPARATOR

The main difference between the groups is due to the different dose of r-FSH which will be given to pa-tients after the 7 days of CFA; namely that patients who need additional r-FSH following corifollitropin-alfa will be randomized on day 8 of the stimulation into 3 study groups. In group A, B and C, ovarian stimula-tion with Corifollitropin alfa (Elonva®, MSD) will be used for ovarian stimulation, followed by 50IU (Group A).

Other: same medications but different dosages

groppo B

ACTIVE COMPARATOR

The main difference between the groups is due to the different dose of r-FSH which will be given to pa-tients after the 7 days of CFA; namely that patients who need additional r-FSH following corifollitropin-alfa will be randomized on day 8 of the stimulation into 3 study groups. In group A, B and C, ovarian stimula-tion with Corifollitropin alfa (Elonva®, MSD) will be used for ovarian stimulation, followed by 150IU (Group B)

Other: same medications but different dosages

Group C

ACTIVE COMPARATOR

The main difference between the groups is due to the different dose of r-FSH which will be given to pa-tients after the 7 days of CFA; namely that patients who need additional r-FSH following corifollitropin-alfa will be randomized on day 8 of the stimulation into 3 study groups. In group A, B and C, ovarian stimula-tion with Corifollitropin alfa (Elonva®, MSD) will be used for ovarian stimulation, followed by 250IU (Group C) of recFSH (Puregon®, MSD).

Other: same medications but different dosages

Interventions

same medications but different dosages OTHER

The main difference between the groups is due to the different dose of r-FSH which will be given to pa-tients after the 7 days of CFA; namely that patients who need additional r-FSH following corifollitropin-alfa will be randomized on day 8 of the stimulation into 3 study groups. In group A, B and C, ovarian stimula-tion with Corifollitropin alfa (Elonva®, MSD) will be used for ovarian stimulation, followed by 50IU (Group A), 150IU (Group B) or 250IU (Group C) of recFSH (Puregon®, MSD)

Group C; groppo B; group A

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female age: \> 18 to \< 38 years
• The patient must have undergone not more than three consecutive unsuccessful IVF/ICSI cycles since the last ongoing pregnancy (whether fresh and/or several frozen ET resulted from these attempts)
• BMI ≤29 Kg /m2
• Patients of ≤ 35 years old, body weight should be ≥ 60kg
• Patients of \>35 years old, body weight should be \> 50 kg
• Regular normo-ovulatory menstrual cycles (26-35 days)
• Basal FSH \<10 IU/l, basal E2 \<60 pg/ml and basal Progesteone (\< 1.5 ng/mL) (normal cycle day-3 basal serum hormone levels), to be measured on cycle day 2 or 3 of the treatment cycle
• Normal ultrasound scan (presence of both ovaries without evidence of abnormality within 6 months)
• AFC \>7 and \< 20
• No pill within the 3 months before treatment
• Signed informed consent

You may not qualify if:

• Polycystic ovarian syndrome (PCOS) according to the Rotterdam classification (2004)
• Oocyte donors
• Poor responder patients (development of \<4 follicles in previous IVF/ICSI or cancelled cycles)
• Endometriosis ≥ grade 3
• Contraindications to the use of gonadotropins
• Abnormal vaginal bleeding of unknown cause
• History of ovarian hyperstimulation syndrome (OHSS) or a previous ovarian stimulation cycle with more than 30 follicles of 11 mm or higher (as recommended by the Elonva® Summary of Product Characteristics)
• A history of recurrent miscarriage (three or more consecutive miscarriages)

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead
• AZ Jan Palfijn Gent: collaborator
• Erasme University Hospital: collaborator

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: September 27, 2018
• Study Start: May 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: May 1, 2020
• Last Updated: March 29, 2019

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share