Clinical trial NCT04416607: Corifollitropin Alpha and Ovarian Response
Official title: Ovarian Response to Controlled Ovarian Stimulation Measured Through the Follicular Output Rate (FORT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility, Female
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: FORT
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Centro de Reproduçao Humana Insemine
state: RGS
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: RGS
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Joao Sabino Lahorgue da Cunha Filho, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: