Corifollitropin Alpha and Ovarian Response

Infertility, Female Clinical Trial

Official title:

Ovarian Response to Controlled Ovarian Stimulation Measured Through the Follicular Output Rate (FORT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04416607
• Other study ID #: 87020518800005327
• Status: Completed
• Phase: N/A
• Start date: June 15, 2018
• Est. completion date: January 31, 2019

Study information

• Verified date: June 2020
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objective: To study whether an administration of corifollitropin alpha modifies the follicular cohort, measured by Follicular Output Rate (FORT), compared to human menopausal gonadotropin (HMG), in infertile patients undergoing in vitro fertilisation (IVF).

M/M: 306 infertile patients undergoing in vitro fertilisation (IVF). Ovarian stimulation protocol will be performed with a single dose of 100 μg (<60kg) or 150 μg (≥60kg) corifollitropin alpha in group 1 (n=147), and 150-300 IU/day human menopausal gonadotropin (HMG) according to age, antimullerian hormone (AMH) level and antral follicle count (AFC) in group 2 (n=150).

Moreover, FORT will be calculated as the ratio of pre-ovulatory follicle (16-22 mm in diameter) count on day of HCG×100/small antral follicle (3-8 mm) count at baseline.

Description:

Patients will be allocated for convenience into two groups: those who would receive corifollitropin alpha (Group 1) or HMG (Group 2).

Ovarian stimulation protocol will be performed with a single dose of 100 μg (<60 kg) or 150 μg (≥60 kg) of corifollitropin alpha (Elonva, Schering-Plough, Brazil) in group 1, which could be followed by daily administration of HMG beginning on day 8 if necessary; in group 2 150-300 IU/day HMG (menotropin, Menopur, Ferring, Brazil) will be administered, starting on cycle day 3, according to age, AMH level and AFC, plus gonadotropin-releasing hormone antagonist co-treatment (Ganirelix 25 mcg/day, Orgalutran, Schering-Plough, Brazil) in a flexible protocol (at least 1 follicle >14 mm or 3 or more follicles >12 mm). Doses will be adjusted as needed by the patient according to the ultrasound, which is performed with a 6 MHz multifrequency transvaginal probe (Toshiba, Japan). The criterion for HCG administration (5.000 IU Choriomon, Biopharma, Brazil) will be at least three follicles greater than 17 mm, and then, 36 hours later, transvaginal oocyte retrieval was performed. After 3 or 5 days, one or two good-quality embryos will be transferred. It will be performed intracytoplasmic sperm injection (ICSI) instead of conventional IVF when major male factor is presented.

Primary outcome measure is FORT. Secondary outcome measures include number of oocytes retrieved, MII, duration of stimulation, number of embryos, embryo quality and clinical pregnancy rate. Adverse events, such as ovarian hyperstimulation syndrome (OHSS) or drug-related complications are also monitored.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

Inclusion Criteria:

• Regular menstrual cycles;

• Body mass index (BMI) of <33.0 kg/m².

Exclusion Criteria:

• Previous ovarian surgery;

• Current diagnosis of polycystic ovarian syndrome (PCOS) or other endocrinopathies;

• History of autoimmune or metabolic disorders.

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Drug:
• Corifollitropin Alfa
Primary outcome measure is ovarian response measured by FORT. Drugs are administrated for controlled ovarian stimulation prior in vitro fertilization.
• Menotropins
Primary outcome measure is ovarian response measured by FORT. Drugs are administrated for controlled ovarian stimulation prior in vitro fertilization.

Locations

Country	Name	City	State
Brazil	Centro de Reproduçao Humana Insemine	Porto Alegre	RGS
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	RGS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FORT	FORT is calculated as the ratio of pre-ovulatory follicle (16-22 mm in diameter) count on day of HCG × 100/small antral follicle (3 -8 mm in diameter) count at baseline	15 days